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. 2017 Mar 13;2017(3):CD012286. doi: 10.1002/14651858.CD012286.pub2

Lirsac 1991.

Study characteristics
Methods Design: parallel‐group randomised controlled trial; blinding not stated
Duration: 15 days
Setting: France; setting not reported
Trial registration: not reported
Participants Population: 45 people with asthma randomised to patient information sheet (group 1) (n = 14) or video group (group 2) (n = 14) or video + spacer (group 3) (n = 17)
Age: 10 to 71 years; mean (SD) age in group 1: 48 (17) years, in group 2: 35 (19) years and in group 3: 26 (20) years
Baseline asthma severity: mean (SD) baseline FEV1 (L): group 1: 2.03 (0.65), group 2: 1.89 (0.61), group 3: 1.77 (0.66)
Inclusion criteria: asthma characterised by attacks of paroxysmal dyspnoea with wheezing and a reversible airway obstruction demonstrated in the year preceding inclusion; using daily MDI, but with imperfect technique; had to speak and understand French, be cooperative with the study procedure and not be using a spacer device. Treatment of patients must be stable for 15 days before the start of the study and during the 15 days of the study
Exclusion criteria: not reported
Percentage withdrawn: no drop‐out
Other allowed medication: not reported, although 22 patients were using ICS, and 22 theophylline
Interventions Intervention summaries: Group 1: Participants received MDI use education by reading an information sheet, which included a statement by the doctor and diagrams, for 3 to 4 minutes
Group 2: Participants viewed a 5‐minute video describing correct use of the MDI
Group 3: Participants viewed the same film as the video group but extended by 2 minutes to describe the use of a spacer device. Participants were also given a spacer device. This group was intended to act as a positive control with optimal inhalation technique
Outcomes Outcomes measured: FEV1, inhalation technique score
Technique assessment method used: 4‐item checklist
Notes Type of publication: single peer‐reviewed journal article (in French)
Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were allocated to 1 of 3 groups according to a randomisation code, revealed, for each participant, just before the education
Allocation concealment (selection bias) Low risk "Revealed, for each patient, just before the education" suggests that this was kept concealed in advance
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 High risk No description of procedures intended to blind outcome assessors to group allocation; therefore assessment of inhaler technique may be at risk of detection bias
Incomplete outcome data (attrition bias)
All outcomes Low risk Appears all participants completed follow‐up
Selective reporting (reporting bias) High risk No prospective trial registration identified. All outcomes listed in Methods appear to be reported, but some in graphs, so unable to extract. Inhaler technique data for positive control group also not given, but likely because use of the spacer device made this group incomparable with the other 2 groups
Other bias Low risk None noted