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Table BSummary table for executive summary

Key Question (KQ) N of studiesResults/Conclusions
KQ1A
54 studies
Combined clinical/laboratory criteria
Rochester criteria for SBI (pooled sensitivity: 94%; specificity range: 36%-69%)23-27,57,60
Philadelphia protocol for SBI (pooled sensitivity: 93%; specificity range: 27%-67%)9,11,12,22,25,58

Boston for SBI (sensitivity: 88.5%, specificity: 56.2%)22,55
Milwaukee for SBI (sensitivity: 96.0%, specificity: 28.0%)10

Rochester and Philadelphia for meningitis (sensitivity range: 50.0%-100.0%)10,11,22
Rochester and Philadelphia for bacteremia (sensitivity range: 33.3%, 83.3%)10,11,22

Other combined clinical (e.g., clinical/good/toxic/ill appearance, impression of sepsis, age, rectal temperature) and laboratory (e.g., serum and urine WBC, ABC, ESR, CRP, urine dipstick) criteria for SBI (sensitivity range: 68.3%28-99.1%,29, specificity range: 37.6%28-77.8%82 ) 5,28-34,37,49,66-68,70,82,85

Other combined clinical and laboratory criteria for bacteremia (sensitivity range: 84.0%-100.0%, specificity range: 17.0%-54.0%).5,31-33

Clinical criteria
The criteria of temperature ≥ 40°C or > 39.5°C for SBI (sensitivity range: 7.3%-26.1%, specificity range: 90.5%-98.8%)30,35,36

Clinical impression of sepsis for bacteremia (sensitivity range: 80.0%40-100.0%33,39)

Laboratory criteria
UA (dipstick; the presence of LE or nitrite, or both) for UTI (sensitivity range: 40.0%54- 85.0%,13 specificity range: 63.6%50– 94.0%52)
UA of urine collected by catheterization (AUC: 86.0%, sensitivity: 86.0% or 43.0%, and specificity: 94.0% or 99.0%)5,51
UA of urine collected by bag (AUC: 71.0%, sensitivity: 76.0% or 25.0%, and specificity: 84.0% or 99.0%)5,51

AUC-WBC for UTI (61.0%, 69.0%)44,45
AUC-ANC for UTI (77.0%)44,45
AUC-ABC for UTI (81.0%)44,45
AUC-CRP for SBI (range: 74.0%-84.0%)30,46,48
AUC-WBC for SBI (range: 68.0%-70.0%) 30,46
AUC-ANC for SBI (71.1%)30
AUC-PCT for SBI (77.0%)48

CRP for bacteremia (AUC-CRP: 68.0%, sensitivity: 69.9%, specificity: 93.8%)46
Urine dipstick for bacteremia (sensitivity: 43.5%, specificity: 82.8%)30
PCT for bacteremia (AUC-PCT: 84.0%)48
KQ1B
14 studies
The Boston criteria for SBI
Age > 28 days: sensitivity (88.5%), specificity (56.2%), PPV (16.2%), NPV (98.1%)55
Age 0–28 days: sensitivity (82.0%), specificity (68.0%), PPV (26.0%), NPV (97.0%)22

The Philadelphia protocol for SBI
Age > 28 days: sensitivity (98.0%, 100.0%), specificity (26.6%, 42.0%)9,12
Age 0 – 28 days: sensitivity (84.4%, 87.9%), specificity (46.8%, 55.0%)11,22

The Philadelphia protocol for bacteremia
Age > 28 days: sensitivity (100.0%)9,12
Age 0–28 days: sensitivity (75.0%, 83.3%)11,22

The Rochester criteria for SBI
Age > 28 days: sensitivity (52.0%, 59.0%), specificity (26.3%)10,56
Age 0–28 days: sensitivity (97.6%, 86.4%), specificity (62.2%, 46.4%), PPV (33.6%, 26.8%), and NPV (99.2%, 93.8%)24,57

The Rochester criteria for bacteremia
Age > 28 days: sensitivity (55.0%)56
Age 0–28 days: sensitivity (86.4%)24

PCT for SBI
Age > 28 days: sensitivity (AUC: 85.0%)61
Age: 0–28 days (AUC: 73.0%)61
KQ1C
4 studies
The data on HSV was scarce39,60,62,63

CSF pleocytosis (≥ 20 WBCs/mm3 and > 1 WBC per 500 red blood cells s/mm3) for HSV: sensitivity of 66.6% (95% CI: 12.5, 98.2) and specificity of 74.6% (95% CI: 71.4, 77.6)63
Insufficient data to compare the findings across age groups
KQ2A
23 studies
Several low-risk criteria/protocols (e.g., Boston, Philadelphia, Rochester, Milwaukee, good appearance, WBC: 5,000-15,000/mm3, ESR < 30 mm/h, normal urinalysis)5,9-12,22-30,37,55,57-60,66,67,70
NPV for SBI (range: 90.0%28-100.0%9)
Sensitivity for SBI (range: 82.0%22,66-100.0%9,26)
Specificity for SBI (range: 27.0%9-69.0%26)
KQ3A
10 studies
Several high-risk criteria (e.g., ill appearance, WBC < 5,000/mm3 or WBC > 15,000/mm3 and WBC ≥ 5/high powered field) for SBI30-34,49,54,68,71,85
Sensitivity: 61.0%68 and 82.0%49
Specificity: 90.0%68 and 76.0%49
PPV: 21.0%49 and 60.0%68
KQ4
11 studies
Significantly higher risk of SBI in infants without viral infection compared to infants with viral infection27,41,60,73-79,86

The ORs ranged from 0.0877 to 0.5865
KQ5
70 studies
Prevalence of SBI (emergency vs. primary care)

North America
Prevalence of SBI in emergency for all infants (range): 4.1%10-25.1%25
Prevalence of SBI in emergency for neonates 0-28 days (range): 11.5%87–23.862
Prevalence of SBI in emergency for infants > 28 days (range): 4.1%10–11.2%88
Prevalence of SBI in primary care for all infants: 9.9%27 and 10.3%5

Taiwan
Prevalence of SBI in emergency for all infants: 17.7%66 and 25.2%82
Prevalence of SBI in emergency for all infants: 16.4%57
KQ6A
4 studies
4 studies reported at least some information on the degree of parental compliance to followup with telephone or return visits to reassess the condition56,59,72,80

The range of followup (12 hours to14 days after initial examination or discharge): 77.4%59-99.8%56
KQ6B
0 studies
No evidence was identified

From: Executive Summary

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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