1. Burden of acute otitis media, recurrent otitis media and tympanostomy tube insertion in urban, minority children less than 7 years of age in Boston: Comparison of Pre and Post PCV13 eras
Stephen Pelton, MD and Kim Shea, PhD
Boston University Schools of Medicine and Public Health

2. Burden of acute otitis media, recurrent otitis media and tympanostomy tube insertion in urban, minority children less than 7 years of age in Boston: Comparison of Pre and Post PCV13 eras
Objective: To evaluate the change in OM disease burden in urban, minority children < 7 yrs. of age, with and without comorbidity, in Boston, MA by comparing AOM, ROM and TT insertion incidence before and after introduction of PCV13*.
Add note/focus about comorbidity?
We propose to assess the burden of pneumonia in children in the BMC health network and to evaluate the impact of PCV13 introduction on disease incidence and excess risk in children with at-risk and high-risk conditions as defined by 2012 Report of The Committee on Infectious Diseases of the American Academy of Pediatrics (AAP)10 and 2013 recommendations by the Advisory Committee on Immunization Practices. 11
* PCV13 introduced in 2nd quarter of 2010 for all children < 5 years of age
Impact of PCV13 vaccination on AOM

3. NOVEL Study Design and Data Source
Impact of PCV13 vaccination on AOM 4
NOVEL Study Design and Data Source
Retrospective cohort analysis of children 0-7 years of age who received primary care with the BMC health system between January 1, 2007 – December 31, 2014
Data Source: De-identified electronic medical records included in the Massachusetts Health Disparities Repository (MHDR)
Includes patient demographics, visit history, clinical diagnoses, medications, and immunization records

4. NOVEL Study Design
To increase the likelihood the child was part of the practice (and not a transient) a primary care visit was required for each year the child was to be included in the data set [as opposed to ER visit].
A random primary care visit was selected for a given year and the experience with OM events tracked for the subsequent 12 months
[this implies that not all OM events are identified as some may have preceded the primary care visit; therefore comparison between years are possible but true incidence is not determined]
Outcomes ascertained via physician-entered problem lists and/or ICD-9CM and/or CPT diagnosis codes included in the MHDR
OM event frequency was compared for the and the time period

5. AOM Outcomes of Interest:
Any AOM
Proportion of children with FIRST EPISODE within 12 months of primary care visit
AOM episodes occurring within 14 days of a previous diagnosis were assumed to be a follow-up or treatment failure and were excluded
Recurrent AOM
Identified all children in data base with ROM (3 episodes within 6 months or 4 episodes within 12 months)
ROM episodes identified within 12 months after the qualifying primary care visit were included
Tympanostomy tube insertion
Identify tube insertion within 12 months of qualifying primary care visit

6. Study population by Year: 2007-2009 vs 2011 vs 2014
No. children
36032
53859 n %
<6 months**
7457
15.6
8099
15.0
6<12 months
3473
7.3
3551
6.6
12<24 months
6784
14.2
7228
13.4
24<60 months
18037
37.8
20373
60<84 months
12006
25.1
14608
27.1
Asian
3708
7.8
3922
Black
25013
52.4
26092
48.4
Hispanic
3298
6.9
3218
6.0
White
5700
11.9
5890
10.9
Other
10038
21.0
14737
27.4
Comorbidity
6223
13.0
6690
12.4
No comorbidity
41534
87.0
47169
87.6
Public insurance
35033
74.6
42005
78.8
Private insurance
11906
25.4
11301
21.2

7. Decline in Proportion of
Proportion of urban Boston children with any AOM by year and comparison of prePCV13 ( ) with postPCV13( )
PCV13 introduced
Period
% with AOM
Decline (%) 95% CI
Pre-PCV13
38.5
19.6%
(19.1 – 20.1)
Post-PCV13
31.0
Decline in Proportion of
Children with AOM: vs

8. Proportion of Urban Boston Children with AOM by year and age and decline in AOM in children in PCV13 era
Year
Pre-PCV13 ( )
Post-PCV13 ( )
DECLINE (%)
No. children
36032
53859
n AOM
n children %
<6 months
1249
5543
22.5
1521
8099
18.8
16.7 ( Z)
6<12 months
905
2575
35.1
1101
3551
31.0
11.8 ( )
12<24 months
1420
5146
27.6
1795
7228
24.8
10.0 ( )
24<60 months
2365
13695
17.3
2777
20373
13.6
21.1 ( )
60<84 months
1003
9073
11.1
1148
14608
7.9
28.9 ( )
PCV13
Declines observed in ALL AGE GROUPING beginning in 2012

9. Proportion of Children with Comorbid conditions and List of most common comorbidities
Age
Comorbidity (%)
< 6 mon.
5.3
6 – 11 mon
11.8
12 – 23 mon
10.8
24 – 59 mon
14.2
> 60 mon
16.5
overall
13.6
Comorbidity N %
Persistent wheeze/asthma
10930
9.8
Hemoglobinopathy
1407
1.3
Congenital and chronic heart disease
871
0.8
Neuromuscular disorder
686
0.6
Chronic lung disease
615
Diabetes
162
0.15
Congenital immunodeficiency 58
< 0.1
HIV 57
Chronic Renal Disease 32
Liver disease 16
Nephrotic Syndrome 8
Down syndrome 6
Malignancy 2
Neuopathy 1
Prematurity was not included as comorbidity because it is uncommonly carried over after year 2 of life

10. Proportion of Urban Boston Children with AOM by year and comorbidity and decline in AOM in children with and without comorbidity in PCV13 era
Year
Pre-PCV13 ( )
Post-PCV13 ( )
DECLINE (%)
No. children
36032
53859
n AOM
n children %
healthy
5884
31311
18.8
7226
47169
15.3
18.5 ( )
comorbidity
1058
4721
22.4
1116
6690
16.7
25.6 ( )
PCV13 introduced

11. ROM by year and decline in ROM: 2011-2014 compared to 2007-2009
Pre-PCV13 ( )
Post-PCV13 ( )
DECLINE (%)
No. children
36032
53859
number
ROM %
numberROM
Recurrent OM
564
1.6%
529
1.0
37.3 ( )

12. Proportion of Urban Boston Children with ROM by year and age grouping
Pre-PCV13 ( )
Post-PCV13 ( )
DECLINE (%)
No. children
36032
53859
n AOM
n children %
<6 months** 4
5543
0.1 6
8099
+2.7 ( )
6<12 months 68
2575
2.6 63
3551
1.8
32.8 ( )
12<24 months
227
5146
4.4
234
7228
3.2
26.6 ( )
24<60 months
214
13695
1.6
188
20373
0.9
40.9 ( )
60<84 months 51
9073
0.6 33
14608
0.2
59.8 ( )

13. Proportion of Urban Boston Children with ROM with and without comorbid conditions and decline in ROM in children in PCV13 era
Year
Pre-PCV13 ( )
Post-PCV13 ( )
DECLINE N
ROM
Children %
Healthy
395
31311
1.3
415
47169 1
30.3 ( )
Comorbidity
179
4721
3.8
109
6690
57.0 ( )

14. Proportion of Urban Boston Children with Tympanostomy Tube Insertion by year among children with and without comorbidity

15. Limitations
We assumed each child with a primary care visit in a given year remained in the population for at least 12 months; however, some children may stop receiving primary care before the end of their 12- month follow-up period, resulting in under ascertainment of AOM cases
We were not able to evaluate the impact of PCV13 on specific pathogens or pneumococcal serotypes
PCV13 is potentially only one contributor to the decline in AOM and ROM observed [as there may be unappreciated confounders].
Each child with a primary care visit in a given year is assumed to be part of the annual cohort however

16. Summary Decline in AOM and ROM in both healthy children and those with
comorbid conditions was observed in urban, largely minority children in
Boston in in association with introduction of PCV13.
In general that declines were observed across all age groupings
The decline in ROM was greater that decline in AOM
The decline was observed approximately 2 years after PCV13 introduction
5. It is likely that there are unappreciated confounders that contribute
to the decline in addition to PCV13

17. Acknowledgements Study Team Kimberly Shea Stephen I. Pelton
Impact of PCV13 vaccination on all-cause pneumonia
IDM Symposium 2017
Acknowledgements
Study Team
Kimberly Shea
Stephen I. Pelton
Aaron Legler
Laura White
Inci Yildirim
Emily Welch
Funded through an investigator initiated grant from the Thrasher Foundation, and Pfizer Inc.,