Tommelein 2014.
| Study characteristics | ||
| Methods |
Design: single‐blind, parallel‐group RCT Duration: 13 weeks Location: Belgium Setting: 170 community pharmacies |
|
| Participants |
Population: 734 participants with COPD randomised into an intervention group (n = 371), receiving protocol‐defined pharmacist care or a control group (n = 363), receiving usual pharmacist care Baseline characteristics COPD severity: unclear Age (mean): intervention 68.4 (SD 9.6) years; control 68.9 (SD 9.7) years % males: intervention 64%; control 69% CAT score (mean): intervention 16.7 (SD 7.8); control 16.4 (SD 7.6) Inclusion criteria: prescription for daily COPD maintenance medication; aged ≥ 50 years, smoking history ≥ 10 pack‐years, regular visitor to the pharmacy, and providing written informed consent Exclusion criteria: current asthma, inability to read and write |
|
| Interventions |
Treatment arms
Allowed co‐medications: theophylline, oral corticosteroids, ICS, LAAC, LABAs, SAAC, SABA, SAAC+SABA, ICS+LABA, triple therapy (LAAC+LABA+ICS) |
|
| Outcomes |
Primary outcomes: inhalation technique and medication adherence Secondary outcomes: exacerbation rate, dyspnoea, COPD‐specific and generic health status and smoking behaviour |
|
| Notes |
Funding: Ghent University, Liège University and GlaxoSmithKline Identifiers: DOI:10.1111/bcp.12242 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed by pharmacists through a central web‐based randomisation system, created by an independent investigator. |
| Allocation concealment (selection bias) | Low risk | Quote: "to conceal assignments, pharmacists performed allocation through a central web‐based randomisation system, created by an independent investigator." |
| Blinding of participants and personnel (performance bias) all outcomes | High risk | Unblinded trial. |
| Blinding of outcome assessment (detection bias) all outcomes | High risk | Unblinded trial. |
| Incomplete outcome data (attrition bias) all outcomes | Low risk | Attrition rates were similar in both groups (6% protocol‐defined pharmacist care vs 4% usual care ), ITT was used for analyses |
| Selective reporting (reporting bias) | Low risk | Trial was registered on website. All outcomes were reported as planned. |
| Other bias | Low risk | None identified. |