Eberhardt 2012.
| Methods | Randomized clinical trial. 1:1 allocation. Not sufficient information to permit judgement on allocation concealment. Follow‐up until 3 months. | |
| Participants | Baseline Age: unilateral 63 years versus bilateral 64 years Participants: unilateral n = 11 versus bilateral n = 11 % female: 45% Disease distribution: heterogeneous Baseline score on outcomes: Mean FEV1 % predicted (SD): unilateral 29.4% (3.95) versus bilateral 31.9 (7.62) Mean QoL in units total score on SGRQ (SD): unilateral 59.0 units (16.3) versus bilateral 58.8 units (14.2) Mean RV % predicted (SD): unilateral 264.8% (47) versus bilateral 269.3 (66.9) Mean TLC % predicted (SD): unilateral 142.2% (15.3) versus bilateral 145.4% (24.9) Mean DLCO: not reported Mean PaO2 in mm Hg (SD): unilateral 67.3 mm Hg (5.95) versus bilateral 62.6 mm Hg (7.99) Mean PaCO2 in mm Hg (SD): unilateral 40.8 mm Hg (5.4) versus bilateral 45.2 mm Hg (4.79) Mean 6MWD in meters (SD): unilateral 305.4 m (68.7) versus control 293.2 m (85.9) |
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| Interventions | Unilateral (group 1) versus partial bilateral (group 2) placement of intrabronchial valves. | |
| Outcomes | ‐ Pulmonary function tests (PFTs), ‐ 6‐min walk distance (6MWD), ‐ Modified Medical Research Council (mMRC) dyspnoea score ‐ St. George Respiratory Questionnaire (SGRQ) |
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| Notes | Grants received from Olympus Europe Holding (Germany) for medical education activities. The intrabronchial valves used for this trial and fees associated with the license to use the St. George Respiratory Questionnaire were provided by Olympus Medical Co, Tokyo, Japan . |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information provided to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information provided to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information provided to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported: no attrition |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Unclear risk | Insufficient information provided to permit judgement |