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

Mehuys 2008.

Study characteristics
Methods Design: parallel‐group randomised controlled trial; blinding not stated
Duration: 26 weeks
Setting: 66 community pharmacies, Belgium
Trial registration: not reported
Participants Population: 201 adults with asthma randomised to a pharmacist education intervention (n = 107) or to usual pharmacy care (n = 94)
Age: mean age (range) in the intervention group 35.2 (19 to 51) years, and in the control group 36.3 (17 to 51) years
Baseline asthma severity: in the intervention group, 5.6% had an ACT score < 15 (indicating poor control), and in the control group 8.5% had a score < 15
Inclusion criteria: required to carry a prescription for asthma medication. In consecutive order, patients visiting the pharmacy were invited to participate in the study when they fulfilled the following inclusion criteria: aged between 18 and 50 years; being treated for asthma for > 12 months; 3) ‘‘using’’ controller medication; and 4) regular visitor to the pharmacy
Exclusion criteria: smoking history of .10 pack‐years, suffering from another severe disease (e.g. cancer) and with an ACT score at screening of,15 (indicating seriously uncontrolled asthma; for ethical reasons, patients were immediately referred to their general practitioner (GP) or respiratory specialist) or equalling 25 (indicating complete asthma control; no room for improvement)
Percentage withdrawn: 25% of participants withdrew from the intervention group, and 26% from the control group
Other allowed medication: not reported
Interventions Intervention summary: Before the start of the present study, participating pharmacists had a training session about asthma (pathophysiology), its non‐pharmacological and pharmacological treatment (GINA guidelines) and use of the study protocol. Participants in the intervention group received a protocol‐defined intervention at the start of the study and at 1‐ and 3‐month follow‐up visits
Control summary: Participants in the control group received usual pharmacist care
Outcomes Outcomes measured: asthma control (ACT), patient diary (nocturnal awakenings due to the number of inhalations of rescue medication; the best of 3 measurements of peak expiratory flow), severe asthma exacerbations (defined as those requiring treatment with oral glucocorticoids (individually recorded in computerised pharmacy records) or an emergency department visit or hospital admission due to asthma), adherence to medication (prescription refill rates and self‐reporting), AQLQ, asthma knowledge inhaler technique
Technique assessment method used: 10‐point checklist for MDI + spacer and 8‐point checklist for DPI (1 point for each correct step, but total score of 0 given in major error made, e.g. failure to remove cap)
Notes Type of publication: single peer‐reviewed journal article
Funding: funding not reported but study authors thank GlaxoSmithKline (GSK) Belgium for permission to use the Asthma Control Test
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The sequence of allocation to either control or intervention group was predetermined by the investigators based on a randomisation table"
Allocation concealment (selection bias) Low risk "Serially numbered, closed envelopes were made for each participating pharmacy. The envelope with the lowest number was opened by the pharmacist upon inclusion of a new patient"
Blinding of participants and personnel (performance bias)
All outcomes High risk It was not possible to blind participants, so some outcomes such as ACT and AQLQ are subject to potential performance bias, as participants knew to which group they were assigned
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding of outcome assessors is not described, and it appears that inhalation technique was assessed by the pharmacist delivering the intervention. Other patient‐reported outcomes (such as ACT and AQLQ) are also at risk because the participant was the outcome assessor
Incomplete outcome data (attrition bias)
All outcomes High risk Approximately 25% of participants dropped out of each arm of the trial. Although reasons were similar and baseline characteristics of those completing and not completing did not differ significantly, rate of drop‐out still high; we cannot be sure this did not affect the results. Secondary outcomes were analysed per protocol rather than by ITT
Selective reporting (reporting bias) Unclear risk No prospective trial registration identified, although all outcomes listed in Methods reported in text/tables
Other bias Low risk None noted