Vitari 2013.
| Study characteristics | ||
| Methods |
Design: parallel‐group randomised controlled trial; blinding not stated Duration: 4 weeks Setting: Comprehensive Lung Center, Pittsburgh, Pennsylvania, USA Trial registration: not reported |
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| Participants |
Population: 43 people with asthma randomised to face‐to‐face demonstration + in‐check simulator (n = 22) or face‐to‐face demonstration (n = 21) Age: not reported Baseline asthma severity: not reported Inclusion criteria: people with asthma new to the Comprehensive Lung Center Exclusion criteria: not reported Percentage withdrawn: 5% of participants withdrew from the intervention arm, and 10% from the control arm Other allowed medication: not reported |
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| Interventions |
Intervention summary: usual teaching with demonstrator models plus In‐Check to simulate resistance and measure inspiratory flow for each specific inhaler used Control summary: usual teaching with demonstrator models |
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| Outcomes |
Outcomes measured: inspiratory flow, number of correct steps met Technique assessment method used: In‐Check inspiratory flow |
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| Notes |
Type of publication: conference abstract Funding: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Twenty‐one subjects were randomized to traditional teaching (control arm) while 22 received In‐Check" ‐ no further details |
| 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 | Unclear risk | 'No description of procedures intended to blind outcome assessors to group allocation but the IN‐CHECK device provides an objective measure of inhalation technique" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 10% drop ‐out in both groups |
| Selective reporting (reporting bias) | High risk | No prospective trial registration identified. Minimal details as reported as conference abstract only |
| Other bias | Low risk | None noted |
ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; AQOL: asthma quality of life; BAI: breath‐activated inhaler; BTS:British Thoracic Society; DPI: dry powder inhaler; ED: emergency department; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; GINA: Global Initiative for Asthma; HCP: healthcare practitioner; ICS: inhaled corticosteroids; IF: inspiratory flow; ITT: intention‐to‐treat; IVC: inspiratory vital capacity; JMI: Jones Morbidity Index; LABA: long‐acting beta2‐agonist; MDI: metered dose inhaler; MTS: multi‐media touch screen system; PACQLQ: PAQLQ completed by parents of children; PAQLQ: Paediatric Asthma Quality of Life Questionnaire; PEFR: peak expiratory flow rate; PIF: peak inspiratory flow; PIL: patient information leaflet; pMDI: pressurised metered dose inhaler; QOL: quality of life; RA: research assistant; SD: standard deviation; TH: Trainhaler; VC: verbal counselling.