Geddes 2000.
| Methods | Randomised parallel‐group trial Method of randomisation: not described Allocation concealment: off‐site Outcome assessor blinding: not described Withdrawals/Dropouts: fully accounted for | |
| Participants | Screened: 174
Randomised: 48 (LVRS 24; control 24) Completed: 47 Median age in years: 61 Diagnosis: CT scan Emphysema: no restriction on pattern and distribution Entry criteria: CT‐confirmed severe emphysema; < 75 years; FEV1 > 500 mL; CS dose < 10 mg/d Exclusion criteria: O2 use > 18 hours/d; asthma; previous thoracic surgery or other serious medical conditions Baseline SF‐36 median in units (IQR): 50 (40 to 59) for LVRS vs 51 (48 to 56) for control Median shuttle walk in metres: 210 for LVRS vs 220 for control Median FEV1 in litres: 0.74 for LVRS vs 0.75 for control Median RV % predicted: 226 for LVRS vs 220 for control Median TLC % predicted: 136 for LVRS vs 129 for control Median PaO2 in mmHg: 74 for LVRS vs 70 for control Median PaCO2 in mmHg: 37 for LVRS vs 38 for control Median DLCO % predicted: 36 for LVRS vs 37 for control |
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| Interventions | LVRS via median sternotomy or thoracoscopy vs continued medical care Continued medical care included rehabilitation and optimised drug therapy. Pulmonary rehabilitation: 6‐week programme consisting of physical, occupational health and nutritional education components Participants were telephoned to encourage them to adhere with the exercise programme. Outcome assessment took place at 3‐, 6‐ and 12‐monthly intervals. |
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| Outcomes | Mortality; FEV1; FVC; TLC; RV; shuttle‐walking distance and quality of life; inspiratory and expiratory mouth pressures; arterial blood gas values | |
| Notes | Supported by research funding from the Royal Brompton Hospital | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomisation was performed by an ‘independent institute’, but specific method was not given. |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | LVRS does not lend itself to blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Methods of handling missing outcome data from questionnaires (if any) not described |
| Selective reporting (reporting bias) | Unclear risk | Prespecified protocol not available for comparison |
| Other bias | Low risk | Low ‐ No other bias was detected. |