Skip to main content
. 2021 Sep 8;2021(9):CD013381. doi: 10.1002/14651858.CD013381.pub2

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Methods Design: prospective, randomised, single‐blinded intervention study (unpublished)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
  1. Counselling intervention: telephone‐based

  2. Control group


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.