Toumas‐Shehata 2014.
Study characteristics | ||
Methods |
Design: parallel‐cluster repeated‐measures randomised controlled trial; blinding not stated Duration: 4 weeks Setting: 1 community pharmacy, Australia Trial registration: not reported |
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Participants |
Population: 19 pharmacists (101 adult patients) randomised to pharmacist training + quantitative inhaler feedback (51 patient participants) or to pharmacist training no quantitative feedback (50 patient participants) (control) Age: mean age not reported; age categories given (18 to > 60 years) Baseline asthma severity: mean (SD) ACQ score in intervention group: 1.6 (0.96), and in control group 1.7 (1.01) Inclusion criteria: diagnosis of asthma and aged 18 years or over; currently using a Turbuhaler (TH) or Accuhaler (ACC) for delivery of preventer asthma medication; having been on the same asthma medication and dose regimen for a minimum of 1 month Exclusion criteria: medication not self‐administered; inability to speak or understand English; inability to return for follow‐up visit; and/or involved in another clinical trial/study Percentage withdrawn: 6% of patient participants withdrew from the intervention group, and 2% from the control group Other allowed medication: not reported |
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Interventions |
Intervention summary: combination of qualitative and quantitative visual feedback for DPI inhalers. Training of community pharmacists occurred on an individual basis with the researcher delivering a 2‐hour 1‐on‐1 training session to each pharmacist in their own community pharmacy. Intervention group pharmacists were also trained as per a train‐the‐trainer approach and an established pharmacist‐training programme with an additional quantitative feedback process. Quantitative feedback involved the use of a portable hand‐held spirometer, which has been developed with the ability to assess breathing manoeuvres associated with the use of different inhaler devices. It is a preprogrammed device that can measure breathing manoeuvres and provides feedback in both numerical and visual/graphic forms. Actual breathing manoeuvres are then compared with optimal manoeuvres for a particular inhaler. This allows patients to see exactly where they are making errors and to what extent. A DVD showing HCPs delivering inhaler technique education to people with asthma was used to consolidate the training of pharmacists. Pharmacists also received an update on basic asthma management and inhaled medications Control summary: current best practice DPI inhaler technique education utilising qualitative visual feedback. Training of community pharmacists occurred on an individual basis, with the researcher delivering a 2‐hour 1‐on‐1 training session to each pharmacist in their own community pharmacy. Control group pharmacists were trained as per a train‐the‐trainer approach and an established pharmacist‐training programme. A DVD showing HCPs delivering inhaler technique education to people with asthma was used to consolidate the training of pharmacists. Pharmacists also received an update on basic asthma management and inhaled medications |
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Outcomes |
Outcomes measured: asthma control (ACQ), inhaler technique Technique assessment method used: The inhaler technique was assessed according to manufacturer‐approved checklists. Individuals were considered to use the correct technique if they were able to perform all steps in the checklist correctly. Inhaler technique data were represented in 2 ways: proportion of participants with correct technique and mean number of steps performed correctly for each device |
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Notes |
Type of publication: peer‐reviewed journal article Funding: This study was funded by the Australian Postgraduate Award. The DVD was funded through Australian Research Council Linkage Project LP LP0882737. Checklists were developed in collaboration with the National Prescribing Service, Sydney, Australia, through funding from the Australian Research Council Linkage Project LP LP0882737 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "19 community pharmacists were recruited and randomised" ‐ 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 | High risk | 'No description of procedures intended to blind outcome assessors to group allocation; therefore assessment of inhaler technique and asthma control may be at risk of detection bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 10% drop‐out in both groups |
Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified; all outcomes listed in methods reported |
Other bias | Low risk | None noted |