Minguez 2017.
Study characteristics | ||
Methods |
Study design: single‐centre, open‐label, parallel individual randomised controlled trial in Spain Duration: 26 weeks Setting: university hospital |
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Participants |
Population: 116 adults recruited from Pneumology Department of Puerta de Hierro University Hospital, in Majadahonda, Spain Baseline characteristics: % Male: 76 RM and 62.5 UC, Mean age: 68 RM and 70 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: 36 RM and 32 UC, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): RM 50 and UC 51.5, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): RM 23 and UC 18, GOLD stage: not reported, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: COPD diagnosis, admission due to exacerbation, no severe coexisting condition, no fever for 48 hours, aerosol treatment at most every 6 hours, IV glucocorticoid < 40 mg twice daily, thoracic radiography without new disease, subjective improvement in patient, familiar suitable environment Exclusion criteria: terminal conditions including neoplasia, alcoholism, IV medication, not able to understand and take part in programme, ICU or NIV during exacerbation, institutionalised, hemodynamic instability |
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Interventions |
Run‐in: early assisted discharge from hospital; measurements taken at baseline, 30 days, and 6 months Treatment arms
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Outcomes |
Primary outcomes: time to first exacerbation Secondary outcomes: satisfaction, anxiety, QOL, adherence to treatment, monitoring compliance, use of health resources |
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Notes |
Funding: Strategic Health Action, PITES‐ISA research projects Other identifier:NCT01951261 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Patients were randomised, but randomisation process was 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; due to nature of intervention, participants or personnel could not be blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study; investigators were not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar attrition in both groups: 5/56 in control group, 6/55 in TM group |
Selective reporting (reporting bias) | Unclear risk | Not all information was provided in publication; continuous outcomes were reported as medians and IQRs. However, upon contact with study authors, we were able to obtain results as means and SDs. Number of participants completing protocol follow‐up was different in the publication from numbers provided by study authors |
Other bias | High risk | Study authors stated that due to selection process, results cannot be generalised to the whole COPD population; patients were selected due to intellect and cognitive capacity |