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

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
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Percentage withdrawn: 6% of patient participants withdrew from the intervention group, and 2% from the control group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
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
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
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
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