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Study flow diagram.
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Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 1 Z score FEV1.
Figuras y tablas -
Analysis 1.1

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 1 Z score FEV1.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 2 Z score FVC.
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Analysis 1.2

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 2 Z score FVC.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 3 Total CF‐CT score (Brody‐II).
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Analysis 1.3

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 3 Total CF‐CT score (Brody‐II).

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 4 Individual CF‐CT scores (at 5 years).
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Analysis 1.4

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 4 Individual CF‐CT scores (at 5 years).

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 5 Z score for weight.
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Analysis 1.5

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 5 Z score for weight.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 6 Z score BMI.
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Analysis 1.6

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 6 Z score BMI.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 7 Positive P.aeruginosa isolates per patient per year.
Figuras y tablas -
Analysis 1.7

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 7 Positive P.aeruginosa isolates per patient per year.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 8 Prevalence of P. aeruginosa in BAL at 5 years age.
Figuras y tablas -
Analysis 1.8

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 8 Prevalence of P. aeruginosa in BAL at 5 years age.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 9 Sensitivity analysis ‐ Prevalence of P. aeruginosa in BAL at 5 years age (40% vs 5%).
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Analysis 1.9

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 9 Sensitivity analysis ‐ Prevalence of P. aeruginosa in BAL at 5 years age (40% vs 5%).

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 10 Sensitivity analysis ‐ Prevalence of P. aeruginosa in BAL at 5 years age (5% vs 40%).
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Analysis 1.10

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 10 Sensitivity analysis ‐ Prevalence of P. aeruginosa in BAL at 5 years age (5% vs 40%).

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 11 Clearance of P.aeruginosa after 1 or 2 eradication treatments.
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Analysis 1.11

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 11 Clearance of P.aeruginosa after 1 or 2 eradication treatments.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 12 Age at first acquisition of P. aeruginosa infection.
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Analysis 1.12

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 12 Age at first acquisition of P. aeruginosa infection.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 13 Number of hospital admissions per patient per year.
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Analysis 1.13

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 13 Number of hospital admissions per patient per year.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 14 Number of hospitalizations per person per year due to non‐P. aeruginosa exacerbations.
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Analysis 1.14

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 14 Number of hospitalizations per person per year due to non‐P. aeruginosa exacerbations.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 15 Duration of hospital admissions due to non‐P.aeruginosa exacerbations.
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Analysis 1.15

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 15 Duration of hospital admissions due to non‐P.aeruginosa exacerbations.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 16 Days as hospital inpatient per patient per year.
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Analysis 1.16

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 16 Days as hospital inpatient per patient per year.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 17 Total cost of care per participant (Australian Dollars).
Figuras y tablas -
Analysis 1.17

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 17 Total cost of care per participant (Australian Dollars).

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 18 Mean hospital admissions cost per patient.
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Analysis 1.18

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 18 Mean hospital admissions cost per patient.

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Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 19 Number of pulmonary exacerbations (requiring oral or intravenous antibiotics) per patient per year.
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Analysis 1.19

Comparison 1 BAL‐directed therapy versus standard therapy, Outcome 19 Number of pulmonary exacerbations (requiring oral or intravenous antibiotics) per patient per year.

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Summary of findings for the main comparison. BAL directed therapy versus standard therapy for cystic fibrosis

BAL‐directed therapy versus standard therapy for cystic fibrosis

Patient or population: people with pulmonary exacerbations in cystic fibrosis
Settings: hospital
Intervention: BAL‐directed therapy
Comparison: standard therapy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Standard therapy

BAL‐directed therapy

Z score FEV1
Follow up: 5 years

The mean z score for FEV1 in the standard therapy group was ‐0.41 (SD 1.23).

The mean z score FEV1 in the intervention group ‐0.56 (SD 1.25) that was 0.15 lower (0.54 lower to 0.24 higher) than the standard therapy group.

157
(1 study)

⊕⊕⊕⊝
moderate1

FEV1 and FVC were measured using standard spirometer after bronchodilatation. The mean difference between the two groups represents the difference in the mean z scores for each parameter.

Z scores for FEV1, FVC were calculated from British reference values (www.lungfunction.org/growinglungs).

Z score FVC
Follow up: 5 years

The mean z score for FVC in the standard therapy group was 0.01 (SD 1.2).

The mean z score FVC in the intervention groups was ‐0.04 (SD 1.31) that was 0.05 higher (0.44 lower to 0.34 higher) than the standard therapy group.

157
(1 study)

⊕⊕⊕⊝
moderate1

FEV1 and FVC were measured using standard spirometer after bronchodilatation. The mean difference between the two groups represents the difference in the mean z scores for each parameter.

Z scores for FEV1, FVC were calculated from British reference values (www.lungfunction.org/growinglungs).

HRCT score (Brody‐II)
Follow up: 5 years

The mean HRCT score in the standard therapy group was 2.83 (SD 3.5).

The mean HRCT score (Brody‐II) in the intervention group was 3.02 (SD 3.48) 0.19 higher (0.93 lower to 1.31 higher) than the standard therapy group.

152
(1 study)

⊕⊕⊕⊕
high

The study had adequate power to detect a difference in HRCT score. HRCT scans were assesses by an independent assessor who was blinded to subject allocation using an updated version of Brody‐II score.

Z score for weight
Follow up: 5 years

The mean z score for weight was ‐0.21 (SD 0.82) in the standard therapy group.

The mean z score for weight in the intervention group was ‐0.15 that was 0.06 higher (0.21 lower to 0.33 higher) than the standard therapy group.

157
(1 study)

⊕⊕⊕⊝
moderate1

The z scores for weight and BMI were calculated from the 2000 CDC Growth Reference Charts (http://cdc.gov/growthcharts). The mean difference between the two groups represents the difference in their z scores for each parameter.

Z score BMI
Follow up: 5 years

The mean z score for BMI was 0.01 (SD 0.83) in the standard therapy group.

The mean z score BMI in the intervention group was 0.03 (SD0.93) that was 0.02 higher (0.26 lower to 0.30 higher) than the standard therapy group.

157
(1 study)

⊕⊕⊕⊝
moderate1

The z scores for weight and BMI were calculated from the 2000 CDC Growth Reference Charts (http://cdc.gov/growthcharts). The mean difference between the two groups represents the difference in their z scores for each parameter.

Number of hospitalizations per participant per year
Follow‐up: 5 years

The number of hospitalizations per participant per year was 1.08 in the standard therapy group.

The number of hospitalizations per participant per year in the intervention group was 1.52 that was 1.4 times higher (1.08 lower to 1.82 higher) than the standard therapy group.

157
(1 study)

⊕⊕⊕⊝
moderate1

Overall cost of care per participant (AUD)

Follow up: 5 years

The total cost of care for each participant was 90,958 AUD (SD 110,255) in the standard therapy group.

The total cost of care in the intervention group was 92,860 AUD (SD 73,378) that was 1902 AUD higher (27,508.98 lower to 31,312.98 higher) than the standard therapy group.

157 (1 study)

⊕⊕⊕⊕
high

The cost of hospital admissions per participant over the total study duration in the intervention group was 9288 AUD lower in the intervention group (34,996.37 lower to 16,420.37 higher).

*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).
AUD: Australian dollars; BAL: bronchoalveolar lavage; BMI: body mass index (weight in kg/height in metres squared); CI: Confidence interval; FEV1: forced expiratory volume at one second; FVC: forced vital capacity; HRCT: high‐resolution computed tomography

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 The study had low statistical power and research is needed to provide definitive answers.

Figuras y tablas -
Summary of findings for the main comparison. BAL directed therapy versus standard therapy for cystic fibrosis
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Comparison 1. BAL‐directed therapy versus standard therapy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Z score FEV1 Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 At 5 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Z score FVC Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 At 5 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Total CF‐CT score (Brody‐II) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3.1 At 5 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Individual CF‐CT scores (at 5 years) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 Bronchiectstasis

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Parencymal disease

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 Mucus plugging

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 Airway wall thickening

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.5 Air trapping

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Z score for weight Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5.1 At 5 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Z score BMI Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6.1 At 5 years

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 Positive P.aeruginosa isolates per patient per year Show forest plot

1

Rate Ratio (Fixed, 95% CI)

Totals not selected

7.1 At 5 years

1

Rate Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Prevalence of P. aeruginosa in BAL at 5 years age Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

9 Sensitivity analysis ‐ Prevalence of P. aeruginosa in BAL at 5 years age (40% vs 5%) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10 Sensitivity analysis ‐ Prevalence of P. aeruginosa in BAL at 5 years age (5% vs 40%) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

11 Clearance of P.aeruginosa after 1 or 2 eradication treatments Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

11.1 At 5 years

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 Age at first acquisition of P. aeruginosa infection Show forest plot

1

Rate Ratio (Fixed, 95% CI)

Totals not selected

12.1 At 5 years

1

Rate Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

13 Number of hospital admissions per patient per year Show forest plot

1

Rate Ratio (Fixed, 95% CI)

Totals not selected

13.1 At 5 years

1

Rate Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

14 Number of hospitalizations per person per year due to non‐P. aeruginosa exacerbations Show forest plot

1

Rate Ratio (Fixed, 95% CI)

Totals not selected

14.1 At 5 years

1

Rate Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

15 Duration of hospital admissions due to non‐P.aeruginosa exacerbations Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

15.1 New Subgroup

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16 Days as hospital inpatient per patient per year Show forest plot

1

Risk Difference (Fixed, 95% CI)

Totals not selected

16.1 New Subgroup

1

Risk Difference (Fixed, 95% CI)

0.0 [0.0, 0.0]

17 Total cost of care per participant (Australian Dollars) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

18 Mean hospital admissions cost per patient Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

19 Number of pulmonary exacerbations (requiring oral or intravenous antibiotics) per patient per year Show forest plot

1

Rate Ratio (Fixed, 95% CI)

Totals not selected

19.1 At 5 years

1

Rate Ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 1. BAL‐directed therapy versus standard therapy
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