Rahmati 2014.
Study characteristics | ||
Methods |
Design: open‐label parallel‐group randomised controlled trial Duration: 4 weeks Setting: "clinics", Iran Trial registration: IRCT2013091514666N1 |
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Participants |
Population: 90 adults with asthma randomised to face‐to‐face training: non‐spacer group (n = 30) or face‐to‐face training: spacer group (n = 30) or no training (control) (n = 30) Age: mean age (SD) in the non‐spacer group was 41.5 (9.1), in the spacer group 42.7 (13.8) and in the control group 44.7 (10.8) Baseline asthma severity: not reported; however, mean duration of asthma ranged from 2.6 to 2.8 years across groups (with SD < 1.0), which is surprisingly short given the age of participants Inclusion criteria: asthmatic patients who had been referred to the clinics affiliated with Shiraz University of Medical Science, Shiraz. 18 to 60 years old, with a past history of using salbutamol MDI for at least 3 months, and not participating in similar interventional programmes Exclusion criteria: smoking, having an asthmatic attack and not willing to continue co‐operation in the study Percentage withdrawn: no withdrawals Other allowed medication: salbutamol |
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Interventions |
Non‐spacer group: Three educational sessions, both theoretical and practical, were held for the 2 intervention groups. Inhalation techniques with and without spacer were taught in the spacer group and the non‐spacer group, respectively. Educational classes included presenting a lecture, showing a PowerPoint, holding a question and answer session and evaluating participants at the end of the session. The content of instructional sessions in the non‐spacer group included the principles of asthma, the importance and advantages of correct inhalation technique, training on inhalation technique without using a spacer and repetition and reinforcement of training presented in 3 sessions Spacer group: as for non‐spacer group but amended to teach correct use of MDI with a spacer Control group: Control group did not receive any interventions |
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Outcomes |
Outcomes measured: PEFR and inhalation skills Technique assessment method used: two 11‐item checklists for checking MDI usage skills scored by 0 and 1 (double‐rated in advance on 10 participants showing correlation of 0.95). A separate checklist was used for MDI with and without spacer, and the control group was assessed on both |
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Notes |
Type of publication: single peer‐reviewed journal article Funding: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The subjects were randomly divided into two intervention groups and a control group using block randomization with a random sequence of 6 block sizes." |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "It should be noted that the patients were aware of the reasons of the interventions and the research was not thus blinded" |
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 | No drop‐out, no exclusions from the analysis |
Selective reporting (reporting bias) | Unclear risk | Prospectively registered trial (IRCT2013091514666N1); all listed outcomes reported |
Other bias | Low risk | None noted |