Donateo 1996.

Study characteristics
Methods	Design: parallel‐group randomised controlled trial; blinding not stated Duration: 1 week Setting: Italy; setting not reported Trial registration: not reported
Participants	Population: 36 older adults with asthma randomised to MDI with Jet spacer (n = 18) or MDI without spacer (n = 18) Age: aged 65 years and older; mean age (SD) years in the intervention group 67.9 (1.6), and in the control group 67.6 (1.8) Baseline asthma severity: mean (SD) PEFR % predicted = 65.4(6) in the intervention group, and in the control group 65.5 (5) Inclusion criteria: aged 65 and older, imperfect inhaler technique at baseline, moderate asthma (PEFR 60% to 80% predicted), reversibility (15%+ increase in FEV1 30 minutes post 200 mcg salbutamol), ability to co‐operate and to be instructed on use of inhalers Exclusion criteria: airway infection, serious comorbidity, inability to abstain from theophylline or LABA use during study Percentage withdrawn: 0% of participants withdrew from the intervention group, and 6% from the control group Other allowed medication: inhaled steroids, inhaled sodium cromoglycate and nedocromil were allowed if patients were already receiving these drugs. LABA, oral bronchodilators and anticholinergics were not allowed
Interventions	Intervention summary: small (approx. 10 cm diameter) spacer device used with MDI. Intended to reduce need for co‐ordination of actuation and inhalation, to reduce oropharyngeal deposition and to increase deposition in lower airways Control summary: standard MDI without spacer device
Outcomes	Outcomes measured: FEV1, PEFR, patient‐reported acceptability of device, adverse events Technique assessment method used: technique not measured or reported
Notes	Type of publication: single peer‐reviewed journal article Funding: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as 'randomised' but no other details
Allocation concealment (selection bias)	Unclear risk	No details
Blinding of participants and personnel (performance bias) All outcomes	High risk	No description of procedures intended to blind participants or personnel to group assignment
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Although no description of procedures intended to blind participants or personnel to group assignment, outcomes measured in this study unlikely to be prone to detection bias and not included in meta‐analysis
Incomplete outcome data (attrition bias) All outcomes	Low risk	Only 1 participant withdrew from the study; reason for withdrawal given
Selective reporting (reporting bias)	Unclear risk	No prospective trial registration identified. However, all outcomes listed in Methods clearly reported in paper
Other bias	Low risk	None noted