Rose 2018.
| Study characteristics | ||
| Methods |
Study design: multi‐centre, open‐label, parallel stratified randomised controlled trial in Canada Duration: 52 weeks Setting: large community teaching hospitals |
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| Participants |
Population: 475 adults recruited from large community teaching hospitals in Canada Baseline characteristics: % Male: 50 IC and 44 UC, Mean age: 71 IC and 71 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: 33 IC and 27 UC, % Anxiety or depression: not reported, Baseline medications: inhaled bronchodilator (95%), inhaled steroid (91%), antihypertensive (65%), influenza vaccine, pneumonia vaccine, FEV₁ (% mean): IC 43 and UC 45, FVC (% mean): not reported, FEV₁/FVC (% mean): IC 50 and UC 52, Current smokers (n): IC 53 and UC 59, GOLD stage: not reported, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: IC 1.3 ± 1.3 and UC 1.4 ± 1.3 Inclusion criteria: COPD diagnosis, FEV₁ < 70%, 2 or more comorbidities as identified by Canadian Thoracic Society COPD Guidelines, CVD, osteopenia/osteoporosis, glaucoma/cataract, cachexia/malnutrition, peripheral muscle dysfunction, lung cancer, diabetes, chronic kidney disease/other primary admitting/presenting diagnosis + COPD as a significant morbidity + ≥ 1 other morbidity, admission to hospital or presenting at a participating ED, first referral to respiratory centre/respirology team with 1 or more ED presentations or hospital admissions in the last 12 months Exclusion criteria: no access to primary care physician, asthma, terminal disease with ≤ 6 months' life expectancy, dementia/no caregiver, uncontrolled psychiatric disorder, cognitive dysfunction, no phone, not able to attend follow‐up visit at participating hospital |
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| Interventions | Measurements taken at baseline and at 3, 6, and 12 months Treatment arms
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| Outcomes |
Primary outcomes: number of emergency department visits Secondary outcomes: number of hospital admissions, number of hospitalisation days, mortality, time to first emergency department presentation, change in BODE index, EQ‐5D‐3L, SGRQ, HADS, COPD‐SES, CSQ8, Caregiver Impact Scale, adherence to chronic disease management measures, smoking cessation, vaccination status ‐ all at 52 weeks |
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| Notes |
Funding: not reported Other identifier: NCT01648621 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performed 1:1 via a centralised computer‐generated schedule stratified by study site |
| Allocation concealment (selection bias) | Unclear risk | No further information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Patients and personnel were not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Premature terminations low in intervention (N = 8) and control (N = 4) groups. 3 people in control group withdrew It should be noted that study authors stated that for secondary outcomes measured at 12 months by questionnaire (e.g. SGRQ, HADS), data were missing, and results should be interpreted with caution, as this would likely have introduced bias in the results |
| Selective reporting (reporting bias) | High risk | HRQOL data were not reported sufficiently; requested further information."Most outcomes mentioned were reported, though we do not have sight of a published protocol". Study authors were "unable to compare the frequency of exacerbation that did not result in an emergency department visit or hospitalisation in the control arm as these participants were not contacted weekly or monthly to collect these data". On contact with study author, we were unable to obtain disaggregated data for each treatment arm, as data analysis was combined |
| Other bias | Low risk | None |