Mehuys 2008.
| Methods | Randomised trial | |
| Participants | 201 asthma patients (intervention 107: control 94) Recruited consecutively in 66 randomly‐selected pharmacies Flanders, Belgium Year of study: January 2006 to October 2006. |
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| Interventions | Intervention patients received a protocol defined intervention at the start of the study and at 1‐ and 3‐month follow‐up. Session 1 consisted of personal education from the pharmacist about: correct use of the inhaler device; understanding asthma; symptoms, triggers and early warnings; understanding asthma medication and difference between controller and reliever medication, and smoking cessation (if relevant). At sessions 2 and 3 the pharmacist advice was based on the patient’s asthma score: If score was < 15 (‘‘uncontrolled’’ asthma): immediate referral to general practitioner or respiratory specialist. If score was 15 ‐ 19 (‘‘insufficiently controlled’’ asthma): review inhalation technique and check controller medication adherence. If score > 20 (‘‘well‐controlled’’ asthma): no specific advice was needed. Control group patients received usual pharmacist care. Frequency: sessions at 0, 1 and 3 months Duration: 3 months |
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| Outcomes | Asthma Control Test score Nights with awakenings Peak expiratory flow (PEF) morning and evening |
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| Notes | Both control and intervention group involved pharmacy care. Funding source: Not specified Conflict of interest: Not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The sequence of allocation to control or intervention group was predetermined by the investigators based on a randomisation table generated with SPSS 14.0 software. |
| Allocation concealment (selection bias) | Low risk | Serially‐numbered, closed envelopes were made for each participating pharmacy. |
| Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | High risk | Diary data: high risk: Quote: "treatment recording (i) nocturnal awakenings due to asthma, (ii) the number of inhalations of rescue medication (during the day or night), and (iii) the best of 3 measurements of peak expiratory flow (PEF) made with a Mini‐Wright Standard Peak Flow Meter in the morning and evening before medication. PEF data are expressed as the percentage of maximum predicted value based on patient’s sex,age, and height." |
| Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | High risk | Self‐measured |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Between group attrition < 10%, however, overall attrition 25%. Reasons for dropout were personal reasons (15), withdrawal from study of the pharmacist (2), relocation (2), lost to follow‐up (27) and other reasons (5). |
| Selective reporting (reporting bias) | Low risk | Main results reported |
| Other bias | Low risk | None |