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

Rahmati 2014.

Study characteristics
Methods Design: open‐label parallel‐group randomised controlled trial
Duration: 4 weeks
Setting: "clinics", Iran
Trial registration: IRCT2013091514666N1
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Percentage withdrawn: no withdrawals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
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
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
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) 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