Zhang 2020.
| Study characteristics | ||
| Methods | RCT; follow‐up 24 months ; control group: u sual care | |
| Participants | Eligible: 702
Randomised: 208; I: 104, C: 104
Completed: 174; I: 85, C: 89
Mean age I: 65 years, C: 66 years
Sex (% male): I: 77, C: 75 Inclusion criteria: older than 45 years of age; diagnosis of GOLD stage II, III, or IV COPD as documented by pulmonary function testing; current or previous smoker with ≥ 10 pack‐years of cigarette smoking; hospitalised for an exacerbation of COPD Exclusion criteria: unable to provide accurate information or to follow instructions, unable to walk even during periods of COPD |
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| Interventions | Hospital outreach PR program me after hospital discharge, delivered i n 2 p hases P h ase 1: 3‐month intensive intervention with i ntervention components ‐ S upervised physical exercise, 2 × per week, 50 minutes per session ‐ S moking cessation (2 sessions) ‐ S elf‐management education, including COPD knowledge, symptom management, instruction on medication intake and adherence, nutritional support. Session every 2 weeks ‐ P sychosocial support (2 sessions) P h ase 2: s tructural follow‐up by telephone (once every 1 to 2 weeks) and home visits (once every 1 to 3 months) up to 24 months by a respiratory nurse. Exercise diary to record daily exercise and symptoms Duration intervention: 3 months intensive with up to 24 months structural follow‐up Dis c iplines involved: respiratory nurse, physiotherapist, tai chi mentor, psychologist, nutritionist |
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| Outcomes | Healthcare utili s ation costs (admission rates, admission days, ED visits) (primary outcome); lung function (FEV ₁, FVC, FEV ₁ % predicted; mMRC; 6MWD; CAT (health‐related QoL); COPD self‐management scale ) | |
| Notes | Dominant component: structured follow‐up | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "block randomization was used. Subjects were randomized after consent and collection of baseline data. Every two patients with the same level of COPD severity were allocated into one block according to their admission dates. In each block, the two patients were further allocated into treatment and control groups randomly based on allocation sequence" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "patients were informed of the results of randomization in person or by phone after discharge" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "single‐blind trial. Given the nature of the intervention, blinding the subjects was not feasible, and the interventionist would also know that those contacted were in the intervention arm" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the statistician was blinded to individual results during the trial, and the allocation‐to‐trial‐arm coding was not revealed until the data set had been sealed. For outcome assessment, the assessor was also blinded to subject allocation" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: c omparable dropout rates between groups (19/104 in intervention, 15/104 in control). Reasons for dropout are comparable between groups |
| Selective reporting (reporting bias) | Low risk | Comment: study protocol is not available; all outcomes from trial registration are reported |