Lou 2015.
| Study characteristics | ||
| Methods | Cluster‐ RCT; follow‐up: 4 years; control: usual care; 14 healthcare centres in rural areas of Xuzhou City, China | |
| Participants | Eligible: 8217 Randomised: 8171, I: 4172, C: 3999 Completed: 6221, I: 3418, C: 2803 Mean age: I: 62 years, C: 61 years Sex (% male): I: 48, C: 48 Inclusion criteria: clinical diagnosis of COPD according to GOLD criteria, verified by spirometry assessment Major exclusion criteria: presence of fever, active tuberculosis, changes in radiographic images or medication in the 4 weeks immediately preceding recruitment, primary diagnosis of asthma or obvious bronchiectasis, cystic fibrosis, interstitial lung disease, previous lung volume reduction surgery, lung transplantation, pneumonectomy, uncontrolled or serious conditions that could potentially affect spirometry tests, refusal to fill out psychological questionnaires |
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| Interventions | Prior to implementation, health management intervention 2‐day training of GP. Training components included general information on COPD, pathogenesis, risk factors, clinical manifestations, clinical assessment, exacerbations, stable stages of treatment and rehabilitation of COPD, providing smoking cessation support, self‐management skills Intervention components ‐ Individual health management plan (based on baseline measurements) ‐ Attendance at educational lecture along with caregiver (every 2 weeks, 40 to 60 minutes per session): total 48 lectures (information on COPD, observation of inhaler techniques, medication, hospitalisation, smoking cessation, vaccination, exercise encouragement, rehabilitation, hand hygiene) ‐ Psychological counselling ‐ Face‐to‐face follow‐up visit (every 2 weeks) on treatment compliance: delivered by GP ‐ Monthly report by GP on patient condition for professional team (pulmonologist, psychiatrist, rehabilitation specialist, nutritionist, respiratory nurse), which provides feedback to GP on focus of action and supervises quality of care ‐ Meeting between professionals (every 2 months) Duration intervention: 48 months Disciplines involved: GP, pulmonologist, psychiatrist, rehabilitation specialist, nutritionist, respiratory nurse |
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| Outcomes | BODE index, FEV₁% predicted, mMRC D yspnoea Scale, 6MWD, BMI, COPD knowledge, COPD‐related deaths, HADS, number of hospital admissions, number of ED visits, change in medication regimen | |
| Notes | Dominant component: e ducation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “centers with experience and those without were then randomly allocated separately into the health management and control groups…” Comment: insufficient detail on randomisation procedure |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail on allocation procedure; additional information sought but not received |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: insufficient detail provided on blinding procedure; given nature of the intervention, participants and treating therapist not likely to have been blinded to group allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not enough information provided to determine whether assessor was blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: “reasons for dropping out after randomisation were refusal to continue participation (25 subjects in the management group and 21 in the control group), lost to follow‐up (19 subjects in the management group and 32 in the control group), and death (610 subjects in the management group and 946 in the control group): Comment: statistically significant larger dropout rate in control group (1217) compared to intervention group (779). Reasons for dropout in control group were death, inability to perform walking test, and incomplete lung function test |
| Selective reporting (reporting bias) | Low risk | Comment: study protocol in not available; published reports include all expected outcomes that were pre‐specified |
| Recruitment bias | Unclear risk | Comment: insufficient detail on whether people involved in recruitment knew about allocation. Additional information sought but not received |
| Baseline imbalance between groups | Low risk | Quote: "health‐care centers were classified into 2 groups: those with previous experience with health management counseling and those without" Comment: healthcare cent r es were stratified on experience to prevent baseline imbalance. No significant difference s between groups on healthcare cent r e level |
| Loss to follow‐up of clusters | Low risk | Comment: no clusters were lost to follow‐up |
| Adequate analysis methods for CRT | High risk | Comment: inadequate analysis for dichotomous outcomes, not accounting for possible clustering effects |