Margolis 2013.
Study characteristics | ||
Methods |
Design: prospective, randomised, single‐blinded intervention study (unpublished) Duration: 26 weeks Location: USA Setting: counselling by telephone |
|
Participants |
Population: 97 adult veterans with COPD, randomised into a counselling intervention (n = 49) or control group (n = 48) Baseline characteristics COPD severity: unclear Age (mean): intervention 71.6 years; control 70.9 years % males: 97.9% of sample Oxygen use (%): intervention 26.5%; control 26.7% Inclusion criteria: aged ≥ 60 years were identified by pharmacy EMR for tiotropium or LABA (or both) with or without an ICS, low adherence by refilling ≥ 1 daily inhaler < 80% of the time over the previous 6 months Exclusion criteria: age < 60 years, cognitive disorder, severe hearing impairment, < 4 months from initial prescription date, activated healthcare power of attorney |
|
Interventions |
Treatment arms
Allowed co‐medications: tiotropium or LABA (or both) with or without ICS as part of inclusion. No other medications reported |
|
Outcomes |
Primary outcomes: incorrect inhaler directions, LABA directions, ICS directions, MDI directions, holding breath, exhaling, LABA breath, MDI inhalation, MDI: wait between puffs, ICS breath, ICS: rinse and spit Secondary outcomes: not reported |
|
Notes |
Funding: ASHP Research and Education Foundation Fostering Young Investigators Federal Services Junior Investigator Research Grant Identifiers: DOI 10.2146/ajhp120241 (1 letter, 2 posters) |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using a computer‐generated random number sequence. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) all outcomes | High risk | Not possible to blind participants or personnel due to nature of intervention. |
Blinding of outcome assessment (detection bias) all outcomes | High risk | Not reported, but unlikely to be blinded due to nature of intervention. |
Incomplete outcome data (attrition bias) all outcomes | Low risk | No dropouts or deaths in the intervention group, 2 deaths and 1 dropout in the control group, but overall low (6%). |
Selective reporting (reporting bias) | Unclear risk | Trial was registered on trial registry website; however, results were reported in a conference poster and a published letter only with no further publication. |
Other bias | Low risk | None identified. |