Table 90Summary clinical evidence profile: Comparison 2. Continuous oral Cephalexin versus antibiotics ‘as required’

Comparison 2. Continuous oral Cephalexin versus antibiotics ‘as required’
OutcomesIllustrative comparative risks* (95% CI)Relative effect (95% CI)No of Participants (studies)Quality of the evidence (GRADE)Comments
Assumed riskCorresponding risk
Antibiotics ‘as required’Continuous oral Cephalexin, antibiotic prophylaxis
Number of children from whom S aureus isolated at least once Respiratory cultures
Follow-up: mean 1 years
468 per 1000145 per 1000
(79 to 266)
RR 0.31
(0.17 to 0.57)
152
(Stutman 2002)
⊕⊕⊕⊝
moderate1
Number of children from whom S aureus isolated at least once Respiratory cultures
Follow-up: mean 2 years
658 per 1000217 per 1000
(145 to 336)
RR 0.33
(0.22 to 0.51)
166
(Stutman 2002)
⊕⊕⊕⊝
moderate2
Number of children from whom S aureus isolated at least once Respiratory cultures
Follow-up: mean 3 years
688 per 1000289 per 1000
(199 to 406)
RR 0.42
(0.29 to 0.59)
141
(Stutman 2002)
⊕⊕⊕⊝
moderate3
Number of children from whom S aureus isolated at least once Respiratory cultures
Follow-up: mean 4 years
839 per 1000352 per 1000
(252 to 495)
RR 0.42
(0.3 to 0.59)
127
(Stutman 2002)
⊕⊕⊕⊝
moderate4
Number of children from whom S aureus isolated at least once Respiratory cultures
Follow-up: mean 5 years
850 per 1000348 per 1000
(238 to 501)
RR 0.41
(0.28 to 0.59)
98
(Stutman 2002)
⊕⊕⊝⊝
low5
Number of children from whom S aureus isolated at least once Respiratory cultures
Follow-up: mean 6 years
778 per 1000280 per 1000
(140 to 552)
RR 0.36
(0.18 to 0.71)
43
(Stutman 2002)
⊕⊕⊝⊝
low6
Lung function FEV1
Follow-up: mean 6 years
The mean lung function in the control group was 115.8The mean lung function in the intervention groups was 2.3 lower
(13.59 lower to 8.99 higher)
119
(Stutman 2002)
⊕⊝⊝⊝
very low7,8
Any pulmonary exacerbations %
Follow-up: mean 6 years
The mean number of pulmonary exacerbation in the control group was 66.8The mean number of pulmonary exacerbations in the intervention groups was 4.9 lower
(22.24 lower to 12.44 higher)
119
(Stutman 2002)
⊕⊝⊝⊝
very low7,9
Number of children requiring admission due to pulmonary exacerbations (annualised rates) not reported
Follow-up: mean 6 years
78 per 100074 per 1000
(20 to 260)
RR 0.94
(0.26 to 3.32)
119
(Stutman 2002)
⊕⊝⊝⊝
very low7,9
Adherence to treatment Parents self-report
Follow-up: mean 6 years
The mean adherence to treatment in the control groups was 85 %The mean adherence to treatment in the intervention groups was 5 higher
(0 to 0 higher)
119
(Stutman 2002)
⊕⊕⊕⊝
moderate7,10
Minor adverse events - generalised rash Parents self-report
Follow-up: mean 6 years
The mean number of generalised rash events in the control group was 0.2The mean – number of generalised rash events in the intervention groups was 0.4 higher
(0.07 lower to 0.87 higher)
119
(Stutman 2002)
⊕⊕⊕⊝
moderate7
Minor adverse events - nappy rash Parents self-report
Follow-up: mean 6 years
The mean number of nappy rash events in the control group was 3.1The mean – number of nappy rash events in the intervention groups was 0.9 higher
(1.06 lower to 2.86 higher)
119
(Stutman 2002)
⊕⊕⊕⊝
moderate7
Minor adverse events - increased stool frequency Parents self-report
Follow-up: mean 6 years
The mean number of increased stool frequency events in the control group was 4.1The mean minor increased stool frequency events in the intervention groups was 0.2 higher
(2.18 lower to 2.58 higher)
119
(Stutman 2002)
⊕⊕⊕⊝
moderate7
Number of children from whom P aeruginosa identified at least once
Follow-up: mean 1 years
312 per 1000358 per 1000
(231 to 564)
RR 1.15
(0.74 to 1.81)
152
(Stutman 2002)
⊕⊝⊝⊝
very low1,9
Number of children from whom P aeruginosa identified at least once
Follow-up: mean 2 years
506 per 1000435 per 1000
(314 to 603)
RR 0.86
(0.62 to 1.19)
166
(Stutman 2002)
⊕⊕⊝⊝
low2,11
Number of children from whom P aeruginosa identified at least once
Follow-up: mean 3 years
594 per 1000582 per 1000
(445 to 772)
RR 0.98
(0.75 to 1.3)
141
(Stutman 2002)
⊕⊝⊝⊝
very low3,9
Number of children from whom P aeruginosa identified at least once
Follow-up: mean 4 years
Study populationRR 1.1
(0.83 to 1.45)
127
(Stutman 2002)
⊕⊕⊝⊝
low4,11
589 per 1000648 per 1000
(489 to 854)
Moderate
589 per 1000648 per 1000
(489 to 854)
Number of children from whom P aeruginosa identified at least once
Follow-up: mean 5 years
550 per 1000709 per 1000
(512 to 979)
RR 1.29
(0.93 to 1.78)
98
(Stutman 2002)
⊕⊝⊝⊝
very low5,11
Number of children from whom P aeruginosa identified at least once
Follow-up: mean 6 years
667 per 1000880 per 1000
(613 to 1000)
RR 1.32
(0.92 to 1.89)
43
(Stutman 2002)
⊕⊝⊝⊝
very low6,11
*

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: CI: confidence interval; FEV1: forced expiratory volume in 1 second; MD: mean difference; RR: risk ratio

1

This study was assessed by the Cochrane review Smyth 2014 as low risk of bias. However, the quality of the evidence was downgraded by 1 for this outcome, as the losses to follow up are over 20% (n=152; N=209).

2

This study was assessed by the Cochrane review Smyth 2014 as low risk of bias. However, the quality of the evidence was downgraded by 1 for this outcome, as the losses to follow up are over 20% (n=166; N=209).

3

This study was assessed by the Cochrane review Smyth 2014 as low risk of bias. However, the quality of the evidence was downgraded by 1 for this outcome, as the losses to follow up are over 20% (n=141; N=209).

4

This study was assessed by the Cochrane review Smyth 2014 as low risk of bias. However, the quality of the evidence was downgraded by 1 for this outcome, as the losses to follow up are over 20% (n=127; N=209).

5

This study was assessed by the Cochrane review Smyth 2014 as low risk of bias. However, the quality of the evidence was downgraded by 2 for this outcome, as the losses to follow up are over 50% (n=98; N=209).

6

This study was assessed by the Cochrane review Smyth 2014 as low risk of bias. However, the quality of the evidence was downgraded by 2 for this outcome, as the losses to follow up are over 50% (n=43; N=209).

7

This study was assessed by the Cochrane review Smyth 2014 as low risk of bias. However, the quality of the evidence was downgraded by 1 for this outcome, as the losses to follow up are over 20% (n=119; N=209).

8

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

9

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

10

Imprecision is not calculable with the data reported

11

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

From: 9, Pulmonary monitoring, assessment and management

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