Ammari 2013.
| Study characteristics | ||
| Methods |
Design: parallel‐group randomised controlled trial; blinding not stated Duration: 6 weeks Setting: 1 outpatient clinic, UK Trial registration: not reported |
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| Participants |
Population: 56 people with asthma randomised to 2 Tone Trainer (2TT) group (n = 23; 17 adults, 6 children) or verbal counselling (VC) group (n = 23; 17 adults, 6 children). Children with adequate technique at initial assessment formed the "control" group (not of interest in this study, as not randomised) (we have assigned the 2TT as the "intervention" arm and the VC as the "control" arm) Age: 4 to 55 years; mean (SD) age in the intervention group: adults 38.5 (10.8) years, children 11.7 (2.4) years; and in the control group: adults 42.4 (7.2) years, children 11.2 (2.4) years Baseline asthma severity: "Mild‐moderate‐severe asthma, according to GINA 2008" Inclusion criteria: 4 to 55‐year‐old asthmatic patients prescribed at least 1 MDI without spacer Exclusion criteria: experienced an acute exacerbation or received oral prednisolone within 4 weeks before recruitment, other illnesses adversely affecting respiratory system, hearing problems and/or unable to distinguish between 1 and 2 tones produced by the 2TT tool Percentage withdrawn: 12% adults, 0% children withdrew from the intervention (2TT) arm; 18% adults and 17% children withdrew from the "control" (VC) arm Other allowed medication: not reported |
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| Interventions |
Intervention summary: verbal training plus use of 2 Tone Trainer (2TT) device, which participants were able to take home. 2TT is a training aid with audible feedback when the required slow inhalation flow is used Control summary: verbal training with emphasis on inspiratory flow rate |
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| Outcomes |
Outcomes measured: lung function measures: change in FEV1; inhalation flow rate; QOL: Juniper's Asthma QOL Questionnaire (AQLQ): adults ‐ Mini AQLQ; children ‐ PAQLQ; PACQLQ by parents of children Technique assessment method used: PIF was used as a measure of inhaler technique |
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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 | "…based on a previously constructed randomization table" |
| 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 | High risk | No description of procedures intended to blind outcome assessors to group assignment; for outcomes such as AQLQ, participant/caregiver is the outcome assessor; therefore these outcomes may be at risk of detection bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 56 asthmatic patients enrolled and 50 completed the 2 study visits as per protocol. Balanced drop‐out |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. No power analysis reported. Outcomes listed in Methods all reported in the text |
| Other bias | Low risk | None noted |