Sorknaes 2013.
| Study characteristics | ||
| Methods |
Study design: multi‐centre, single‐blinded, parallel individual randomised controlled trial in Denmark Duration: 26 weeks Setting: hospital (2 hospital sites) |
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| Participants |
Population: 266 adults recruited from acute medicine unit and respiratory medicine unit at 2 hospital sites in Funen, Denmark Baseline characteristics: % Male: 40 RM and 38 UC, Mean age: 71 RM and 72 UC, % White: not reported, % African: not reported, % LTOT: 9 RM and 12 UC, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): RM 33 and UC 37, FVC (% mean): not reported, FEV₁/FVC (% mean): RM 48 and UC 47, Current smokers (n): RM 48 and UC 46, GOLD stage: severe, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: RM 2.75 (2.32) and UC 2.64 (2.5) Inclusion criteria: 40+ years, COPD diagnosis by spirometry, COPD exacerbations (defined as increased need for medication, increased dyspnoea, increased expectorate, increased coughing), resident in Funen and islands, written consent Exclusion criteria: unable to communicate via phone and/or computer screen, previous participant in protocol or received COPD suitcase, systolic BP < 100 mmHg, saturation < 90, malignancy or lobar pneumonia, cancer/recurrence of cancer in last 5 years, septic shock, AMI/renal disease/or other serious disease, diagnosed HF (EF < 30%), refused to participate |
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| Interventions | Measurements taken at baseline and at 4, 8, 12, and 26 weeks Treatment arms
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| Outcomes |
Primary outcomes: hospital admission Secondary outcomes: mortality, time before first re‐admission, hospital admissions, hospital days |
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| Notes |
Funding: partial funding from European Commission, Danish Health Foundation, Danish Nurses' Organisation, University of Southern Denmark, OUH‐Odense University Hospital, Svenborg Hospital Other identifier: NCT01178879 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A central telephone voice response service from a computer‐generated system was used for block randomisation of 10 and 14. 1:1 allocation was done, and randomisation was stratified by smoking status and trial site |
| Allocation concealment (selection bias) | Unclear risk | Reported allocation in 1:1 ratio; allocation concealment of outcome assessors not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial was single‐blind; assumed patients and personnel were not blinded to treatment allocation, although not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded to treatment allocation as reported on the NCT website |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Number of patient deaths was similar in each group at 26 weeks; overall attrition in each group < 10% |
| Selective reporting (reporting bias) | Unclear risk | All outcomes were reported as planned; trial was registered at clinicaltrials.gov. Study authors mentioned time‐to‐event data as survival analyses, but there was no access to the data. Study authors reported as days without standard deviations |
| Other bias | Low risk | None |