Wei 2014.
Study characteristics | ||
Methods |
Design: RCT Duration: 52 weeks Location: China Setting: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China |
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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 |
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Interventions |
Treatment arms
Allowed co‐medications: anticholinergic agents, LABA, ICS, xanthines, carbocisteine |
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Outcomes |
Primary outcome: medication adherence which was measured by tablet counts + direct interview Secondary outcomes: severe exacerbation rate and HRQoL (SGRQ) |
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Notes |
Funding: not reported Identifiers: none |
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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.