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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 1 Lung function (% predicted).
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Analysis 1.1

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 1 Lung function (% predicted).

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 2 Number of children from whom S aureus isolated at least once.
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Analysis 1.2

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 2 Number of children from whom S aureus isolated at least once.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 3 Z score weight.
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Analysis 1.3

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 3 Z score weight.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 4 Z score length.
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Analysis 1.4

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 4 Z score length.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 5 Number of children requiring admission (annualised rates).
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Analysis 1.5

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 5 Number of children requiring admission (annualised rates).

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 6 Days in hospital (annualised rates).
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Analysis 1.6

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 6 Days in hospital (annualised rates).

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 7 Number of children receiving additional antibiotics.
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Analysis 1.7

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 7 Number of children receiving additional antibiotics.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 8 Days of additional antibiotics.
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Analysis 1.8

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 8 Days of additional antibiotics.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 9 Number of children from whom H influenzae isolated at least once.
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Analysis 1.9

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 9 Number of children from whom H influenzae isolated at least once.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 10 Number of children from whom P aeruginosa isolated at least once.
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Analysis 1.10

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 10 Number of children from whom P aeruginosa isolated at least once.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 11 Adverse effects: mean number of days experiencing adverse effect.
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Analysis 1.11

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 11 Adverse effects: mean number of days experiencing adverse effect.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 12 Shwachman score.
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Analysis 1.12

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 12 Shwachman score.

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Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 13 Chrispin‐Norman Score.
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Analysis 1.13

Comparison 1 Anti‐staphylococcal prophylaxis versus 'as required' treatment, Outcome 13 Chrispin‐Norman Score.

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Summary of findings for the main comparison. Summary of findings ‐ Prophylactic compared with 'as required' anti‐staphylococcal antibiotics for cystic fibrosis

Prophylactic compared with 'as required' anti‐staphylococcal antibiotics for cystic fibrosis

Patient or population: children with cystic fibrosis

Settings: outpatients

Intervention: prophylactic anti‐staphylococcal antibiotics (prophylaxis)

Comparison: anti‐staphylococcal antibiotics 'as required'

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

'As required'

Prophylaxis

FEV₁ (% predicted (Knudson 1983))

Follow up: 6 years

The mean FEV₁ was 1.1 % predicted in the 'as required' group.

The mean FEV₁ was 0% predicted higher (0.08 % lower to 0.08 % higher) in the prophylaxis group.

NA

119

(1 study)

⊕⊕⊕⊝
moderate1

Number of people with one or more isolates of S aureus (sensitive strains)

Follow up: 2 years

541 per 1000.

114 per 1000
(70 to 189).

OR 0.21 (95% CI 0.13 to 0.35).

315
(3 studies)

⊕⊕⊝⊝
low2,3

Significant advantages to prophylaxis antibiotics were also shown at the following time points.

1 year: OR 0.27 (95% CI 0.15 to 0.48).

3 years: OR 0.22 (95% CI 0.13 to 0.38).

4 years: OR 0.10 (95% CI 0.04 to 0.25).

5 years: OR 0.09 (95% CI 0.03 to 0.26).

6 years: OR 0.11 (95% CI 0.03 to 0.46).

Number of people with one or more isolates of P aeruginosa

Follow up: 2 years

346 per 1000.

256 per 1000

(156 to 426).

OR 0.74 (95% CI 0.45 to 1.23).

312

(3 studies)

⊕⊕⊝⊝
low2,3

Trend towards more P aeruginosa in the intervention group at 4, 5 and 6 years.

Number of people needing additional antibiotics

Follow up: up to 7 years

1000 per 1000.

180 per 1000

(10 to 1000).

OR 0.18 (95% CI 0.01 to 3.60).

119

(1 study)

⊕⊕⊝⊝
low1,4

Weight (z score)

Follow up: 2 years

The mean z score for weight ranged from ‐0.25 to ‐0.69 in the 'as required' group.

The mean z score for weight was 0.06 higher (0.03 lower to 0.45 higher) in the prophylaxis group.

NA

140

(2 studies)

⊕⊕⊝⊝
low2,5

There was also no significant difference between treatment groups at the following time points.

6 months: MD 0.30 (95% CI ‐0.54 to 1.14).

1 year: MD ‐0.12 (95% CI ‐0.50 to 0.26).

3 years: MD ‐0.14 (95% CI ‐0.58 to 0.30).

Acquisition of multiply‐resistant S aureus

Follow up: NA

Outcome not reported

NA

Adverse events of treatment

Follow up: up to 7 years

See comment.

See comment.

NA

119

(1 study)

⊕⊕⊕⊝
moderate1

There were no significant differences between treatment groups in terms of generalised rash, nappy rash and increased stool frequency.

*The basis for the assumed risk is the control group risk (mean risk or event rate depending on type of outcome data) across studies. 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).
CI: confidence interval;FEV₁: forced expiratory volume in one second;FVC: forced vital capacity;MD: mean difference;NA: not applicable; OR: risk ratio; P aeruginosa : Pseudomonas aeruginosa; S aureus: Staphylococcus aureus.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1. Downgraded once due to incomplete outcome data: outcomes were measured only in the children completing treatment per protocol (Stutman 2002).
2. Downgraded once due to applicability: nose and throat swabs were used to assess for infection, rather than sputum samples, which have been shown to poorly predict lower respiratory infection (Armstrong 1996).
3. Downgraded once due to risk of bias: studies contributing evidence were not blinded or had incomplete outcome data (or both) (Chatfield 1991; Stutman 2002; Weaver 1994).
4. Downgraded once due to imprecision: only a small number of children did not require additional antibiotics; this small number has results in a wide confidence interval around the relative effect.
5. Downgraded once due to inconsistency: high levels of heterogeneity present in analysis (I² = 81%).

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings ‐ Prophylactic compared with 'as required' anti‐staphylococcal antibiotics for cystic fibrosis
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Table 1. Results of infant lung function testing (Beardsmore 1994)

Measurement*

Baseline

At 1 year

Prophylaxis

As required

Prophylaxis

As required

TGV (thoracic gas volume)

0.05

0.98

‐0.22

0.09

Gaw (airway conductance)

1.16

0.00

‐1.79

‐1.13

Vmax FRC (maximum flow at functional residual capacity)

‐0.69

‐0.75

‐0.61

‐0.85

*All lung function values expressed as standard error scores
Figuras y tablas -
Table 1. Results of infant lung function testing (Beardsmore 1994)
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Comparison 1. Anti‐staphylococcal prophylaxis versus 'as required' treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Lung function (% predicted) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 FEV₁ at 6 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 FVC at 6 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Number of children from whom S aureus isolated at least once Show forest plot

3

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 1 year

2

248

Odds Ratio (M‐H, Fixed, 95% CI)

0.27 [0.15, 0.48]

2.2 2 years

3

315

Odds Ratio (M‐H, Fixed, 95% CI)

0.21 [0.13, 0.35]

2.3 3 years

2

260

Odds Ratio (M‐H, Fixed, 95% CI)

0.22 [0.13, 0.38]

2.4 4 years

1

127

Odds Ratio (M‐H, Fixed, 95% CI)

0.10 [0.04, 0.25]

2.5 5 years

1

98

Odds Ratio (M‐H, Fixed, 95% CI)

0.09 [0.03, 0.26]

2.6 6 years

1

43

Odds Ratio (M‐H, Fixed, 95% CI)

0.11 [0.03, 0.46]

3 Z score weight Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 6 months

1

32

Mean Difference (IV, Fixed, 95% CI)

0.30 [‐0.54, 1.14]

3.2 1 year

2

133

Mean Difference (IV, Fixed, 95% CI)

‐0.12 [‐0.50, 0.26]

3.3 2 years

2

140

Mean Difference (IV, Fixed, 95% CI)

0.06 [‐0.33, 0.45]

3.4 3 years

1

112

Mean Difference (IV, Fixed, 95% CI)

‐0.14 [‐0.58, 0.30]

4 Z score length Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

4.1 6 months

1

23

Mean Difference (IV, Fixed, 95% CI)

0.52 [‐0.36, 1.40]

4.2 1 year

2

127

Mean Difference (IV, Fixed, 95% CI)

0.06 [‐0.36, 0.48]

4.3 2 years

2

134

Mean Difference (IV, Fixed, 95% CI)

‐0.23 [‐0.65, 0.19]

4.4 3 years

1

112

Mean Difference (IV, Fixed, 95% CI)

‐0.07 [‐0.50, 0.36]

5 Number of children requiring admission (annualised rates) Show forest plot

3

243

Odds Ratio (M‐H, Fixed, 95% CI)

0.96 [0.50, 1.86]

6 Days in hospital (annualised rates) Show forest plot

3

242

Mean Difference (IV, Fixed, 95% CI)

0.88 [‐1.35, 3.10]

7 Number of children receiving additional antibiotics Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

8 Days of additional antibiotics Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

9 Number of children from whom H influenzae isolated at least once Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

9.1 2 years

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 Number of children from whom P aeruginosa isolated at least once Show forest plot

3

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

10.1 1 year

2

247

Odds Ratio (M‐H, Fixed, 95% CI)

1.42 [0.77, 2.60]

10.2 2 years

3

315

Odds Ratio (M‐H, Fixed, 95% CI)

0.74 [0.45, 1.23]

10.3 3 years

2

261

Odds Ratio (M‐H, Fixed, 95% CI)

0.88 [0.51, 1.51]

10.4 4 years

1

127

Odds Ratio (M‐H, Fixed, 95% CI)

1.28 [0.62, 2.64]

10.5 5 years

1

98

Odds Ratio (M‐H, Fixed, 95% CI)

1.97 [0.85, 4.58]

10.6 6 years

1

43

Odds Ratio (M‐H, Fixed, 95% CI)

3.67 [0.77, 17.35]

11 Adverse effects: mean number of days experiencing adverse effect Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11.1 Generalised rash

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 Nappy rash

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.3 Increased stool frequency

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 Shwachman score Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

12.1 3 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

13 Chrispin‐Norman Score Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

13.1 3 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 1. Anti‐staphylococcal prophylaxis versus 'as required' treatment
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