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 |
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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15 days before the start of the study and during the 15 days of the study Exclusion criteria: not reported Percentage withdrawn: no drop‐out Other allowed medication: not reported, although 22 patients were using ICS, and 22 theophylline |
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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 |
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Outcomes |
Outcomes measured: FEV1, inhalation technique score Technique assessment method used: 4‐item checklist |
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Notes |
Type of publication: single peer‐reviewed journal article (in French) Funding: not reported |
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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 |