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. 2021 Sep 8;2021(9):CD013381. doi: 10.1002/14651858.CD013381.pub2

De Tullio 1987.

Study characteristics
Methods Design: RCT
Duration: 26 weeks
Location: USA
Setting: 1 outpatient pulmonary clinic at VA medical centre
Participants Population: 60 participants with COPD randomly assigned to counselling (n = 30) or control (n = 30)
Baseline characteristics
COPD severity: mild to severe
Age (mean): counselling 62.1 (SD 9.3) years; control 63.2 (SD 6.7) years
% male: 100%
Pulmonary disease severity (1 = mild, 5 = severe) (mean): counselling 2.1 (SD 1.3); control 2.0 (SD 1.0)
Inclusion criteria: adult men with COPD; theophylline established 1 month prior to entering; dosing stabilise for at least 1 week; able to take medications unassisted
Exclusion criteria: none stated but only uncomplicated CHF in study
Interventions Treatment arms

  1. Comprehensive counselling session: verbal instructions stressing on importance of medication, how it works, importance of maintaining blood levels and any questions in 1 session, 3−5 minutes

  2. Control: asked if any questions about drug therapy


Allowed co‐medications: number of other medications (mean): counselling 6.0 (SD 2.9), control 4.9 (SD 2.3)
Outcomes Primary outcomes: adherence (ratio of actual to predicted serum levels; number of refills in 155 days)
Secondary outcomes: not reported
Notes Funding: not reported
Identifiers: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned to intervention or control group, based on social security numbers.
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding of participants and personnel (performance bias)
all outcomes High risk Not reported although due to the nature of the intervention blinding would be an issue.
Blinding of outcome assessment (detection bias)
all outcomes Unclear risk Not reported.
Incomplete outcome data (attrition bias)
all outcomes Unclear risk The number of participants not completing prescription refills was similar: 30% in the intervention arm and 23% in the control arm.
Selective reporting (reporting bias) Unclear risk Trial protocol was not found, unclear if outcomes were reported as planned.
Other bias Low risk None identified.