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Table 4 The quality of evidence assessment for as-needed use of ICS/FABA in intermittent and mild asthma by GRADE approach

From: Corticosteroid plus β2-agonist in a single inhaler as reliever therapy in intermittent and mild asthma: a proof-of-concept systematic review and meta-analysis

Outcome No. of participants (studies) Relative effect (95% CI) Anticipated absolute effects (95% CI) Certainty What happens
Comparison group Intervention group Difference
ICS/FABA compared to FABA for intermittent or mild persistent asthma
Patient or population: intermittent or mild persistent asthma
Setting: inpatients and outpatient
Intervention: ICS/FABA
Comparison: FABA
Exacerbations
follow up: range 12 weeks to 44 weeks
No. of participants: 643
(4 RCTs) [17, 27, 29, 30]
RR 0.56 (0.40 to 0.78) 23.1% 12.9% (9.2 to 18.0) 10.1% fewer (13.8 fewer to 5.1 fewer) MODERATEa Compared with the as-needed FABA regimen, the as-needed use of ICS/FABA as monotherapy probably reduces moderate to severe exacerbations
Severe exacerbations
follow up: range 24 weeks to 44 weeks
No. of participants: 477
(3 RCTs) [17, 27, 29]
RR 0.64 (0.44 to 0.95) 17.2% 11.0% (7.5 to 16.3) 6.2% fewer (9.6 fewer to 0.9 fewer) MODERATEa Compared with the as-needed FABA regimen, the as-needed use of ICS/FABA as monotherapy probably reduces severe exacerbations
Time to first exacerbation
follow up: range 12 weeks to 44 weeks
No. of participants: 551
(3 RCTs) [17, 29, 30]
HR 0.520 (0.345 to 0.785) 27.0% 15.1% (10.3 to 21.9) 11.9% fewer (16.7 fewer to 5.1 fewer) MODERATEa Compared with FABA regimen, ICS/FABA regimen probably reduces the HR for the time to first exacerbation
ICS/FABA compared to ICS for intermittent or mid persistent asthma
Patient or population: intermittent or mid persistent asthma
Setting: inpatients and outpatient
Intervention: ICS/FABA
Comparison: ICS
Exacerbations
follow up: range 12 weeks to 44 weeks
No. of participants: 1090
(4 RCTs) [17, 26, 29, 30]
RR 1.39 (1.08 to 1.79) 14.7% 20.4% (15.9 to 26.3) 5.7% more (1.2 more to 11.6 more) MODERATEa Compared with regular ICS regimen, the as needed ICS/FABA regimen probably has slightly higher risk of moderate to severe exacerbations
Severe exacerbations
follow up: range 16 weeks to 44 weeks
No. of participants: 870
(3 RCTs) [17, 26, 29]
RR 1.34 (1.02 to 1.75) 16.4% 22.0% (16.7 to 28.7) 5.6% more (0.3 more to 12.3 more) MODERATEb Compared with regular ICS regimen, the as needed ICS/FABA regimen probably has slightly higher risk of severe exacerbations
Time to first exacerbation
follow up: range 12 weeks to 44 weeks
No. of participants: 591
(3 RCTs) [17, 29, 30]
HR 1.295 (0.805 to 2.083) 11.1% 14.1% (9.0 to 21.8) 3.0% more (2.1 fewer to 10.6 more) MODERATEa Compared with regular ICS regimen, the as needed ICS/FABA regimen probably increases the HR for the time to first exacerbation
ICS compared to FABA for intermittent or mild persistent asthma
Patient or population: intermittent or mild persistent asthma
Setting: inpatients and outpatient
Intervention: ICS
Comparison: FABA
Time to first exacerbation
follow up: range 12 weeks to 44 weeks
No. of participants: 536
(3 RCTs) [17, 29, 30]
HR 0.420 (0.274 to 0.644) 27.0% 12.4% (8.3 to 18.4) 14.6% fewer (18.7 fewer to 8.7 fewer) MODERATEa Compared with FABA regimen, regular ICS regimen probably reduces the HR for the time to first exacerbation
  1. The risk in the intervention group (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)
  2. GRADE Working Group grades of evidence:
  3. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect;
  4. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different;
  5. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect;
  6. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
  7. No. number, CI confidence interval, RR risk ratio, HR hazard ratio
  8. aThe results obtained for different diagnostic criteria of asthma and beclomethasone equivalent consumption
  9. bThe results obtained for different beclomethasone equivalent consumption