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

Wei 2014.

Study characteristics
Methods Design: RCT
Duration: 52 weeks
Location: China
Setting: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
Participants Population: 117 people with COPD randomly assigned to pharmaceutical care (n = 58) or usual care (n = 59)
Baseline characteristics
COPD severity: mild to severe
Age (mean): pharmaceutical care 65.2 (SD 8.1) years; usual care 63.9 (SD 6.2) years
% male: pharmaceutical care 65.5%; usual care 65%
FEV1 (mean): pharmaceutical care 1.07 (SD 0.41) L; usual care 1.15 (SD 0.47) L
Number of medications (mean): pharmaceutical care 6.2 (SD 4.3); usual care 6.6 (SD 5.0)
Inclusion criteria: stable COPD (respiratory symptoms and medication unchanged for ≥ 4 weeks before enrolment); postbronchodilator FEV1:FVC ratio < 0.70 and FEV1 25–79% predicted value); ≥ 2 consecutive visits to our hospital for the treatment of COPD; no participation in a respiratory rehabilitation in the past year; no previous diagnosis of asthma, dementia, uncontrolled psychiatric disease, and severe heart, liver and kidney disease
Exclusion criteria: adherence patients (taken > 80% of the daily dose prescribed), refusal to participate the study
Interventions Treatment arms
  1. Pharmaceutical care: individualised education and a series of telephone counselling for 6 months provided by clinical pharmacists. 20–30 minutes per session, 5–6 sessions, calls: generally telephone call (4–5 sessions) at the midpoint between 2 clinic visits; frequency of a 10‐minute telephone

  2. Usual care: general counselling but no individualised education and follow‐up telephone counselling


Allowed co‐medications: anticholinergic agents, LABA, ICS, xanthines, carbocisteine
Outcomes Primary outcome: medication adherence which was measured by tablet counts + direct interview
Secondary outcomes: severe exacerbation rate and HRQoL (SGRQ)
Notes Funding: not reported
Identifiers: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomisation codes were computer‐generated."
Allocation concealment (selection bias) Unclear risk Allocation was concealed using sealed envelopes labelled with consecutive numbers. Envelopes were opened and patients were allocated to treatment group.
Blinding of participants and personnel (performance bias)
all outcomes High risk Participants were aware of which group they were allocated to; however, pharmacists were blinded to the randomisation codes.
Blinding of outcome assessment (detection bias)
all outcomes Unclear risk It was not clear if the outcome assessors were blinded.
Incomplete outcome data (attrition bias)
all outcomes Low risk Similar withdrawal numbers in each arm, 9 in the intervention group and 8 in the control group.
Selective reporting (reporting bias) Unclear risk Could not find a trial protocol, unclear of outcomes were reported as planned, time points on the CONSORT diagram were not clear.
Other bias Low risk None identified.

6MWT: six‐minute walk test; AECOPD: acute exacerbation of COPD; APCD: Adherence among Patients with Chronic Disease; ATS: American Thoracic Society; CAT: COPD Assessment Test; CCQ: Clinical COPD Questionnaire; CHF: chronic heart failure; COPD: chronic obstructive pulmonary disease; EMR: electronic medical record; EOT: end of treatment; ERS: European Respiratory Society; EQ‐5D: EuroQol 5 dimension; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; HRQoL: health‐related quality of life; ICS: inhaled corticosteroid; IMB: information‐motivation‐behavioural‐based model; IQR: interquartile range; ITT: intention‐to‐treat; LAAC: long‐acting anticholinergic; LABA: long‐acting beta2‐adrenoceptor agonist; LAMA: long‐acting muscarinic receptor antagonist; MDI: metered dose inhaler; MI: motivational interviewing; n: number of people; PACIC: Patient Assessment of Quality of Care; pMDI: pressurised metered dose inhaler; RCT: randomised controlled trial; SAAC: short‐acting anticholinergic; SABA: short‐acting beta2‐adrenoceptor agonist; sal/FP: salmeterol/fluticasone propionate; SD: standard deviation; SDM‐PE: shared decision‐making and patient engagement programme; SE: standard error; SF: short form; SFC: salmeterol–fluticasone combination; SGRQ: St George's Respiratory Questionnaire; VA: Veterans Affairs.