Table 15.1GRADE evidence profile for optimal time to change the primary empiric treatment in unresponsive fever

Quality assessmentSummary of findings
No of patientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionNo empiric antibioticEmpiric antibiotic ± placeboAntibiotic & additional drugRelative RR (95%CI)
P value
Absolute effect
Mortality Pizzo, et al., (1982)
1randomised trialv. serious limitations1N/Ano serious indirectnessserious imprecision2552--VERY LOW
Median time to defervescence (range). Pizzo, et al., (1982)
1randomised trialv. serious limitations1N/Ano serious indirectnessserious imprecision211 days
(3-22 days)
8 days
(3-23 days)
6 days
(2-20 days)
--VERY LOW
Mortality (within 30 days). EORTC International anti-microbial therapy co-operative group (1989)
1randomised trialserious limitations3N/Ano serious indirectnessserious imprecision4-1411P=0.04-VERY LOW
Median time to defervescence (95%CI). Cometta, et al., (2003)
1randomised trialno serious limitationsN/Ano serious indirectnessserious imprecision5-4.3 days
(3.5-5.1 days)
3.5 days
(2.4-4.4 days)
P=0.75-LOW
Mortality between days 14 and 31. Cometta, et al., (2003)
1randomised trialno serious limitationsN/Ano serious indirectnessserious imprecision5-8/794/86RR=0.46
(0.15-1.38)
P=0.29
-LOW
Defervescence within 72 hours. Erjavec, et al., (2000)
1randomised trialserious limitations6N/Ano serious indirectnessserious imprecision4-27/5825/56RR=0.96
(0.64-1.43)
P=0.98
-VERY LOW
Mortality whilst aplastic. Erjavec, et al., (2000)
1randomised trialserious limitations6N/Ano serious indirectnessserious imprecision4-4/586/56RR=1.55
(0.49-4.98)
P=0.70
-VERY LOW
1

No mention of allocation concealment; randomisation method not discussed; blinding not apparent.

2

Very low patient numbers and/or event rates.

3

No mention of allocation concealment; randomisation method not discussed; blinding of assessment may have occurred but not of treatment.

4

Low patient numbers and/or event rates.

5

Low patient numbers and /or event rates. Trial terminated early.

6

No mention of allocation concealment, scant details of randomisation of treatment.

From: Subsequent Treatment: guideline chapter seven

Cover of Neutropenic Sepsis: Prevention and Management of Neutropenic Sepsis in Cancer Patients
Neutropenic Sepsis: Prevention and Management of Neutropenic Sepsis in Cancer Patients.
NICE Clinical Guidelines, No. 151.
National Collaborating Centre for Cancer (UK).
Copyright © National Collaborating Centre for Cancer, 2012.

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