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. 2023 Feb 3;2023(2):CD013733. doi: 10.1002/14651858.CD013733.pub2

Summary of findings 1. Digital technology (TIM) compared with standard treatment (TBM) for monitoring adherence to inhaled therapies in people with cystic fibrosis.

Digital technology compared with standard treatment for monitoring adherence to inhaled therapies in people with cystic fibrosis
Patient or population: children aged 5 to 16 years
Settings: home or outpatient
Intervention: adaptive aerosol delivery of inhaled therapy with a digitally set TIM
Comparison: adaptive aerosol delivery of inhaled therapy set in TBM (standard technique)
Outcomes Illustrative comparative risks* (95% CI) Relative effect
(95% CI) No of participants
(studies) Certainty of the evidence
(GRADE) Comments
Assumed risk Corresponding risk
TBM TIM
Adherence to the inhaled treatment: 
 
Follow‐up: up to 6 months
The mean (SD) adherence in the TBM group was 65% (33). The mean adherence in the TIM group was 24% higher (2.95% higher to 45.05% higher). MD 24.00 (2.95 to 45.05) 20
(1)
 
⊕⊕⊝⊝Lowa,b
 
 
Treatment burden
 
Follow‐up: up to 6 months
This outcome was not measured.
 
 
 
 
 
QoL
 
Follow‐up: up to 6 months
This outcome was not measured.
 
 
 
 
FEV1 (mean change from baseline, % predicted)
 
Follow‐up: up to 6 months
Mean (SD) FEV1 (% predicted) improved by 1.2% (12.77).
 
 
Mean change in FEV1 % predicted in the TIM group was 1.00% higher (9.37% lower to 11.37% higher). MD 1.00 (‐9.37 to 11.37) 20
(1)
⊕⊕⊝⊝Lowa,b  
Number of pulmonary exacerbations
 
Follow‐up: end of study
This outcome was not measured.
 
 
 
 
 
*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% CI) 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 1 second; MD: mean difference; QoL: quality of life; TBM: tidal breathing mode; TIM: target inhalation mode
GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
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.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
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.

aDowngraded one level due to imprecision as the CI around the mean is large.
bDowngraded one level due to indirectness as the study was carried out in children aged 5 to 16 years of age. The results may not be applicable to adults.