Jódar‐Sanchez 2013.
| Study characteristics | ||
| Methods |
Study design: single‐centre, open‐label, parallel individual randomised controlled trial in Spain Duration: 17 weeks Setting: hospital care |
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| Participants |
Population: 45 adults recruited from hospital in Madrid, Spain Baseline characteristics: % Male: 95 RM and 95 UC, Mean age: 74 RM and 71 UC, % White: not reported, % African: not reported, % LTOT: 100 RM and 100 UC, % Home oxygen: not reported, % Anxiety or depression: RM 10 and UC 10, Baseline medications: not reported, FEV₁ (% mean): RM 38 and UC 37, FVC (% mean): RM 59 and UC 63, FEV₁/FVC (% mean): not reported, Current smokers (n): not reported, GOLD stage: very severe, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: adult diagnosis of COPD and chronic respiratory failure with LTOT indication according to GOLD, at least 1 hospitalisation in the last year, clinically stable in the last 3 months Exclusion criteria: not following LTOT at enrolment, no home telephone line, not given informed consent |
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| Interventions |
Run‐in: measurements taken at baseline and at end of study Treatment arms
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| Outcomes |
Primary outcomes: exacerbations, A&E department visits, hospital admissions Secondary outcomes: SGRQ, EQ‐5D, patient satisfaction |
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| Notes |
Funding: Spanish Ministry of Science and Innovation Other identifier: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Trial was reported as randomised, but randomisation process not described |
| Allocation concealment (selection bias) | Unclear risk | No further information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study; neither study investigators nor patients were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study; no measures were reported to show that outcome assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 death and 1 withdrawal in each group were observed; all analysed |
| Selective reporting (reporting bias) | Unclear risk | Outcomes were reported as planned; however, no trial registration details were found |
| Other bias | Low risk | None |