Table 2Test results – Combined clinical & laboratory criteria I (Boston criteria, Milwaukee protocol, Philadelphia protocol, Rochester criteria, and Yale observation score)

Study ID

QUADAS Total Score
N/n*
Age Range
N (%) with SBISensitivity
(%)
[95% CI]
Specificity
(%)
[95% CI]
PPV
(%)
[95% CI]
NPV
(%)
[95% CI]
Other
Boston Criteria
Kadish (2000)22

[12]
394/372
1–28 d
Total: 45 (12.1)
UTI: 32
Bacteremia: 12
Meningitis: 5
Cellulitis: 3
Septic arthritis: 1
Gastroenteritis: 1
Pneumonia: 1
82.0
[67.4, 91.5]
68.0
[62.8, 73.1]
26.0
[19.4, 34.4]
97.0
[93.0, 98.4]
LR+=2.58
LR-= 0.26
Bacteremia: 1275.0
[42.8, 93.3]
63.3
[58.1, 68.3]
6.4
[3.1, 12.1]
98.7
[96.0, 99.6]
LR+=2.04
LR-= 0.39
Kaplan (2000)55

[8]
3,166/2,190
28–90 d
Total: 191 (8.7)
Types of SBI: NR
88.5
[82.8, 92.5]
56.2
[54.0, 58.4]
16.2
[14.0, 18.6]
98.1
[97.0, 98.7]
LR+= 2.02
LR-= 0.20
Stanley (2005)35

[13]
5,279/5,279
0–90 d
Total: 480 (9.1)
UTI: 305
Meningitis: 10
Bacteremia: 39
Bacteremia/meningitis: 8
Bacteremia/UTI: 11
Pneumonia: 70
Cellulitis: 26
Bacterial enteritis: 11
99.5
[98.3, 99.9]
NRNRNRNR
Milwaukee Protocol
Bonadio (1993)10

[5]
534/534
29–60 d
Total: 24 (4.5)
UTI: 11
Bacterial meningitis: 4
Bacteremia: 6
Bacterial enteritis: 2
Pneumonia: 1
96.0
[88.0, 100.0]
28.0
[23.0, 36.0]
5.9
[3.6, 8.2]
99.3
[98.0, 100.0]
LR+= 1.33
LR-= 0.15
Philadelphia Protocol
Baker (1999)11

[13]
254/254
3–28 d
Total: 32 (12.5)
UTI: 17
Bacteremia: 8
Meningitis: 4
Cellulitis: 1
Gastroenteritis: 2
Peritonitis: 1
Osteomyelitis: 1
84.4
[67.0, 95.0]
46.8
[40.0, 53.0]
18.6
[12.0, 25.0]
95.4
[90.0, 99.0]
LR+=1.58
LR-= 0.33
Bacteremia: 875.0
[35.6, 95.5]
43.5
[37.2, 49.9]
4.1
[1.7, 9.1]
98.1
[92.7, 99.7]
LR+=1.32
LR-= 0.57
Meningitis: 4100.0
[39.6, 100.0]
43.6
[37.4, 49.9]
2.7
[0.9, 7.3]
100.0
[95.7, 100.0]
LR+=1.77
LR-= 0
Baker (1999)9

[14]
422/422
29–60 d
Total: 43 (10.2)
UTI: 17
Bacteremia: 9
Meningitis: 5
Gastroenteritis: 5
Cellulitis: 5
Chlamydia pneumonia: 2
Enterocolitis: 1
Osteomyelitis: 1
Septic arthritis: 1
100.0
[89.7, 100.0]
26.6
[22.3, 31.4]
14.0
[10.0, 17.7]
100.0
[96.0, 100.0]
LR+= 1.36
LR-= 0
Bacteremia: 9100.0
[62.9, 100.0]
24.4
[20.4, 28.9]
2.8
[1.4, 5.4]
100.0
[95.4, 100.0]
LR+= 1.32
LR-= 0
Meningitis: 5100.0
[46.3, 100.0]
24.2
[20.3, 28.7]
1.5
[0.6, 3.8]
100.0
[95.4, 100.0]
LR+= 1.31
LR-= 0
Baker (1993)12

[11]
747/747
29–56 d
Total: 65 (8.7)
UTI: 24
Bacteremia: 19
Meningitis: 9
Cellulitis: 6
Gastroenteritis: 13
Adenitis: 1
98.0
[92.0, 100.0]

100.0
[93.0, 100.0]
42.0
[38.0, 46.0]

42.0
[38.3, 45.9]
14.0
[11.0, 17.0]

14.1
[11.1, 17.7]
99.7
[98.0, 100.0]

100.0
[98.3, 100.0]
LR+=1.69
LR-= 0.03

LR+=1.72
LR-= 0
Bacteremia: 19100.0
[79.0, 100.0]
39.4
[35.8, 43.0]
4.1
[2.5, 6.5]
100.0
[98.3, 100.0]
LR+=1.65
LR-= 0
Meningitis: 9100.0
[62.8, 100.0]
38.9
[35.4, 42.5]
2.0
[0.9, 3.8]
100.0
[98.3, 100.0]
LR+=1.63
LR-= 0
Brik (1997)58

[12]
492/492
0–90 d
Total: 60 (12.3)
UTI: 40
Meningitis: 2
Bacteremia: 10
Gastroenteritis: 4
Cellulitis: 2
Adenitis: 1
86.6
[74.8, 93.6]
66.6
[62.0, 71.0]
26.5
[20.6, 33.4]
97.3
[94.5, 98.7]
LR+= 2.60
LR-= 0.20
Condra (2010) 59

[7]
1,672/240
29–60 d
Data on only low risk infants (n=62)
Total: 2 (NR)
UTI: 2
NRNRNR96.7
[NR]
NR
Garra (2005)25

[12]
302/259
0–56 d
Total: 65 (25.1)
UTI: 51
Bacteremia/UTI: 5
Bacteremia: 8
Bacteremia/Meningitis:1
98.5
[92.0, 100.0]
41.9
[38.0, 46.0]
13.9
[11.0, 17.0]
99.7
[98.0, 100.0]
LR+= 1.70
LR-= 0.03
Bacteremia: 887.5
[46.7, 99.3]
19.1
[13.6, 25.9]
4.7
[2.1, 9.9]
97.0
[82.9, 99.8]
LR+= 1.08
LR-= 0.65
Kadish (2000)22

[12]
394/372
1–28 d
Total: 45 (12.1)
UTI: 32
Bacteremia: 12
Meningitis: 5
Cellulitis: 3
Septic arthritis: 1
Gastroenteritis: 1
Pneumonia: 1
87.0
[72.5, 94.4]
55.0
[49.5, 60.5]
21.0
[15.5, 27.6]
97.0
[92.8, 98.7]
LR+=1.92
LR-= 0.24
Bacteremia: 1283.3
[50.8, 97.0]
51.1
[45.8, 56.3]
5.3
[2.7, 9.9]
98.9
[95.6, 99.8]
LR+=1.70
LR-= 0.32
Meningitis: 5100.0
[46.3, 100.0]
50.7
[45.5, 55.9]
2.6
[0.9, 6.5]
100.0
[97.4, 100.0]
LR+=2.03
LR-= 0
Rochester Criteria
Baskin (1992)56

[11]
503/501
28–89 d
Total: 27 (5.4)
Bacteremia: 8
UTI + bacteremia: 1
UTI: 8
Gastroenteritis: 10
52.0
[31.7, 71.6]
NRNRNRNR
Bacteremia: 855.5
[22.6, 84.6]
NCNCNCNC
Bonadio (1993)10

[5]
534/532
29–60 d
Total: 22 (4.1)
UTI: 11
Meningitis: 4
Bacteremia: 6
Klebsiella pneumoniae: 1
59.0
[36.6, 78.5]
26.3
[22.5, 30.3]
3.3
[1.9, 5.8]
93.7
[88.0, 96.9]
LR+=0.80
LR-= 1.55
Bacteremia: 633.3
[6.0, 75.9]
26.3
[22.5, 30.3]
0.5
[0.09, 2.1]
97.1
[92.3, 99.0]
LR+=0.45
LR-= 2.53
Meningitis: 450.0
[9.1, 90.8]
26.7
[23.0, 30.7]
0.5
[0.08, 2.1]
98.6
[94.5, 99.7]
LR+=0.68
LR-= 1.87
Byington (2004)60

[10]
894/888 (infants without viral infections)
1–90 d
Total: 109 (12.3)
Types of SBI: bacteremia, UTI, meningitis, pneumonia
91.7
[84.5, 95.9]
36.0
[32.6, 39.4]
16.6
[13.8, 20.0]
96.9
[94.0, 98.5]
LR+= 1.43
LR-= 0.23
Chiu (1997)57

[12]
250/250
4–28 d
Total: 41 (16.4)
UTI: 16
Bacteremia/Meningitis: 7
Bacteremia/Enteritis: 3
Enteritis: 2
Bacteremia/Osteomyelitis: 1
Others: NR
97.6
[92.9, 100.0]
62.2
[55.6, 68.8]
33.6
[25.1, 42.1]
99.2
[97.7, 100.0]
LR+= 2.58
LR-= 0.04
Bacteremia/Meningitis: 7
Bacteremia/Enteritis: 3
Bacteremia/Osteomyelitis: 1
100.0
[67.8, 100.0]
54.8
[48.2, 61.2]
9.2
[4.9, 21.2]
100.0
[96.4, 100.0]
LR+= 2.21
LR-= 0
Dagan (1988)26

[11]
237/236
< 60 d
Total: 22 (9.3)
Bacteremia: 8
UTI: 6
Otitis media: 6
Gastroenteritis: 1
Bacteremia: 1 (not included)
100.0
[80.7, 100.0]
68.8
[62.1, 74.8]
23.8
[15.7, 34.3]
100.0
[96.8, 100.0]
LR+= 3.20
LR-= 0
Bacteremia: 8100.0
[59.7, 100.0]
64.9
[58.3, 71.0]
9.0
[4.3, 17.6]
100.0
[96.8, 100.0]
LR+= 2.85
LR-= 0
Dagan (1985)27

[12]
233/233
< 60 d
Total: 23 (9.8)
Bacteremia: 9
UTI: 6
Other: NR
96.0
[78.0, 100.0]
68.0
[61.0-74.0]
24.7
[19.9, 25.8]
99.3
[96.3, 100.0]
LR+= 2.99
LR-= 0.06
Ferrera (1997)24

[12]
188/134
0–28 d
Total: 22 (16.4)
UTI: 13
UTI/meningitis: 1
Bacteremia: 4
Bacteremia/UTI: 1
Bacteremia/meningitis: 1
Listeria meningitis: 1
Pneumonia: 1
86.4
[64.0, 96.4]
46.4
[36.3, 56.7]
26.8
[17.2, 38.8]
93.8
[81.8, 98.4]
LR+=1.61
LR-= 0.29
Bacteremia: 4100.0
[39.5, 100.0]
41.7
[32.7, 51.3]
5.6
[1.8, 14.3]
100.0
[90.2, 100.0]
LR+=1.71
LR-= 0
Garra (2005)25

[12]
302/259
0–56 d
Total: 65 (25.1)
UTI: 51
Bacteremia/UTI: 5
Bacteremia: 8
Bacteremia/Meningitis: 1
96.9
[89.3, 99.6]
36.6
[29.8, 43.8]
33.9
[31.1, 34.8]
97.3
[90.3, 99.5]
LR+=1.52
LR-= 0.08
Bacteremia: 875.0
[35.5, 95.5]
28.3
[22.9, 34.3]
3.2
[1.3, 7.3]
97.3
[89.6, 99.5]
LR+=1.04
LR-= 0.88
Bacteremia/UTI: 5100.0
[46.3, 100.0]
28.7
[23.3, 34.8]
2.6
[0.9, 6.5]
100.0
[93.6, 100.0]
LR+=1.40
LR-= 0
Jaskiewicz (1994)23

[10]
1057/931
0–60 d
Total: 66 (7.0)
UTI: 34
Skin/soft tissue infection: 18
Bacteremia: 16
Gastroenteritis: 4
Pneumonia: 1
92.4
[82.5, 97.2]
50.0
[46.5, 53.3]
12.3
[9.6, 15.6]
98.9
[97.2, 99.6]
LR+=1.84
LR-= 0.15
Bacteremia: 16 (1.7)87.5
[60.4, 97.8]
47.5
[44.2, 50.8]
2.8
[1.6, 4.8]
99.5
[98.2, 99.9]
LR+= 1.66
LR-= 0.26
Stanley (2005)35

[13]
5,279/5,279
0–90 d
Total: 480 (9.1)
UTI: 305
Meningitis: 10
Bacteremia: 39
Bacteremia/meningitis: 8
Bacteremia/UTI: 11
Pneumonia: 70
Cellulitis: 26
Bacterial enteritis: 11
99.8
[98.6, 99.9]
NRNRNRNR
YIOS score ≥ 7 (affect, respiratory status/effort, peripheral perfusion)
Bonadio (1993)21

[13]
242/233
0–29 d
Total: 29 (12.4)
Meningitis: 10
Bacteremia: 12
UTI: 7
76.0
[56.0, 88.9]
81.9
[75.7, 86.7]
37.3
[25.3, 50.8]
96.0
[91.6, 98.2]
ROC given
Yale Observation Scale (YOS) > 10
Baker (1990)64

[8]
126/126
29–56 d
Total: 12 (9.5%)
UTI: 5
Bacterial sepsis: 4
Other: 3
33.3
[11.3, 64.5]
72.8
[63.5, 80.5]
11.4
[3.7, 27.6]
91.2
[82.9, 95.8]
LR+= 1.22
LR-= 0.91
Bacterial sepsis: 475.0
[21.9, 98.6]
73.7
[64.8, 81.1]
8.5
[2.2, 24.1]
98.9
[93.1, 99.9]
LR+= 2.85
LR-= 0.33
Zorc (2005)651,513/995
1–60 d
Total: 91 (9.0%) UTI4.4
[1.4, 11.5]
92.6
[90.6, 94.1]
5.6
[1.8, 14.5]
90.5
[88.5, 92.3]
LR+=0.60
LR-= 1.03

d=day(s); LR=likelihood ratio; NPV= negative predictive value; NR=not reported; PPV= positive predictive value; SBI=serious bacterial infection; UTI=urinary tract infection; YIOS=Young Infant Observation scale

Values based on Philadelphia protocol + no immunodeficiency syndrome, band-to-neutrophil ratio < 0.2

*

N/n: number of infants enrolled/ number of infants with culture and test results

The Rochester Criteria does not require cerebrospinal fluid (CSF) testing through lumbar puncture (LP)

From: Results

Cover of Diagnosis and Management of Febrile Infants (0–3 Months)
Diagnosis and Management of Febrile Infants (0–3 Months).
Evidence Report/Technology Assessments, No. 205.
Hui C, Neto G, Tsertsvadze A, et al.

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