Khdour 2009.

Study characteristics
Methods	Aim of study: to investigate the impact of a pharmacy‐led disease and medicine management programme (with a strong focus on self‐management) in patients with COPD on clinical and humanistic outcomes Study design: RCT (1 clinic; allocation: individual) Number of arms/groups: 2
Participants	Description: patient/consumer Geographic location: Ireland Setting: outpatient clinic (COPD hospital clinic) Inclusion criteria: confirmed diagnosis of COPD by hospital consultant for ≥ 1 year, FEV1 of 30% to 80% of predicted normal value, > 45 years old Exclusion criteria: CHF, moderate to severe learning difficulties (judged by hospital consultant), attended pulmonary rehab programme in last 6 months, severe mobility problems, terminal illness Number of participants randomised: 173 (86 vs 87) Number of participants included in analysis: 143 (71 vs 72) Age: mean ± SD: 65.63 ± 10.1 intervention vs 67.3 ± 9.2 control Gender: female: 55.8% vs 56.3% Ethnicity: not specified Number of medications: combined prescription and non‐prescription: 8.3 ± 2.9 vs 8.0 ± 3.8 Frailty/Functional impairment: not specified Cognitive impairment: not specified Comorbidities: comorbid conditions: n = 41 (47.7%) vs n = 44 (50.5%)
Interventions	Group 1 ‐ Pharmacy‐led COPD disease and medicine management programme: preliminary assessment with pharmacist to determine individual needs (data on disease knowledge, smoking, medication adherence, self‐efficacy, exercise, and diet). Intervention pharmacist then discussed drug therapy with consultant and provided education (adherence, inhaler technique, home exercises, management of COPD symptoms). Pharmacist demonstrated techniques and then observed patients carrying out the techniques (a booklet on these techniques was given to take home). Pharmacist provided advice using motivational interviewing technique (e.g. quit smoking) and provided customisable action plan for exacerbations (include advice to GPs about antibiotics). Initial intervention lasted for approximately 1 hour (slightly longer for smokers) Group 2 ‐ Usual care (medical and nursing staff only ‐ no pharmacist involvement) Co‐intervention: N/A Provider: pharmacist Where: outpatient clinic When and how often: baseline and 6 months in person, phone call at 3 and 9 months Intervention personalised: yes ‐ tailored according to preliminary assessment
Outcomes	Timing of outcome assessment: baseline and 12 months Medication adherence (subjective) : Morisky Adherence (measures adherence with 4 Yes/No response items: forgetting, carelessness, stopping when feeling better, and stopping when feeling worse); yes = 1, no = 0; high adherence (score 0 to 1) vs low adherence (score 2 to 4) Knowledge about medicines (objective): COPD knowledge questionnaire (validated) ‐ effectiveness of education in helping persons with COPD. 16 T/F questions, correct response = 1, range 0 to 16, higher score = better knowledge Health‐related quality of life (subjective): St George's Respiratory Questionnaire (SGRQ) total score = SGRQ is a 76‐item supervised self‐administered survey; scores for symptoms, activity, and impact to give global view of respiratory health. Scores 0 to 100; high = poor health Adverse clinical health outcomes (objective): ED visits, hospital admissions, and unscheduled GP visits, assessed via questionnaire and computer records for past year
Notes	Trial registration: not specified Consumer involvement: not specified Funding source: Chest Heart and Stroke (N Ireland) financial support Dropout: 13 (7 vs 6) withdrew, 8 died (3 vs 5), 9 were lost to follow‐up (5 vs 4)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation carried out via the minimisation method (see reference). Groups matched as closely as possible
Allocation concealment (selection bias)	Unclear risk	Not specified
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and research staff unblinded
Blinding of outcome assessment (detection bias) All outcomes	High risk	Research pharmacist not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up described and balanced
Selective reporting (reporting bias)	Low risk	Reported results for all outcome measures listed in methods section
Other bias	Unclear risk	Sample size based on SQRG ‐ aimed for 180 patients (90 vs 90) ‐ not reached