Table 123Summary clinical evidence profile: Comparison 6. Continuous alternating therapy versus intermittent treatment: aztreonam lysine + tobramycin or placebo + tobramycin

Comparison 6. Continuous alternating therapy versus intermittent treatment: aztreonam + tobramycin or placebo + tobramycin
OutcomesIllustrative comparative risks* (95% CI)Relative effect (95% CI)No of Participants (studies)Quality of the evidence (GRADE)Comments
Assumed riskCorresponding risk
Intermittent treatment: aztreonam lysine + tobramycin or placebo + tobramycinContinuous alternating therapy
Lung function: % change in FE1% predicted
Scale from: 0 to 100
Follow-up: 20 weeks1
The mean % change in FEV1% predicted in the intermittent treatment groups was 0.04The mean % change in FEV1% predicted in the continuous alternating therapy groups was 1.33 higher
(1.05 to 1.61 higher)
88
(Flume 2016)
⊕⊕⊕⊝
moderate2
Time to next pulmonary exacerbation--HR
0.89 (0.49 to 1.6)
88
(Flume 2016)
⊕⊕⊝⊝
low2,3
Quality of life: change in CFQ-R
Scale from: 0 to 100
Follow-up: 20 weeks1
The mean change in CFQ-R in the intermittent treatment groups was −2.06The mean change in CFQ-R in the continuous alternating therapy groups was 3.06 higher
(2.35 to 3.77 higher)
88
(Flume 2016)
⊕⊕⊝⊝
low2,4
Minor adverse events: cough
Follow-up: 3 months
435 per 1000761 per 1000
(526 to 1000)
RR
1.75 (1.21 to 2.54)
88
(Flume 2016)
⊕⊕⊝⊝
low2,5
Serious adverse events: dyspnoea
Follow-up: 3 months
522 per 1000308 per 1000
(183 to 527)
RR
0.59 (0.35 to 1.01)
88
(Flume 2016)
⊕⊕⊝⊝
low2,5
Serious adverse events (not treatment related)
Follow-up: 3 months
522 per 1000501 per 1000
(334 to 751)
RR
0.96 (0.64 to 1.44)
88
(Flume 2016)
⊕⊝⊝⊝
very low2,6
*

The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

Abbreviations: CFQ-R: cystic fibrosis questionnaire reviewed; CI: confidence interval; FEV1: forced expiratory volume in 1 second; MD: mean difference; mg: milligrams; RR: risk ratio

1

Values at 4, 12 and 20 weeks were averaged

2

The quality of the evidence was downgraded by 1 due to unclear allocation concealment, blinding, and data collection/reporting

3

The quality of the evidence was downgraded by 1 as the 95% CI crossed the null effect line

4

The quality of the evidence was downgraded by 1 as the 95% CI crossed 1 clinical MID

5

The quality of the evidence was downgraded by 1 as the 95%CI crossed 1 default MID

6

The quality of the evidence was downgraded by 2 as the 95%CI crossed 2 default MIDs

From: 9, Pulmonary monitoring, assessment and management

Cover of Cystic Fibrosis
Cystic Fibrosis: Diagnosis and management.
NICE Guideline, No. 78.
National Guideline Alliance (UK).
Copyright © NICE 2017.

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