VENT EU 2012.
| Methods | Randomized clinical trial. 2:1 allocation. Follow‐up until 12 months. | |
| Participants | Baseline Age: treatment 60 years versus control 60 years Participants: treatment n = 111 versus control n = 60 % female: 25% Disease distribution: homogenous and heterogeneous Baseline score on outcomes: Mean FEV1 % predicted (SD): treatment 29% (8) versus control 30% (8) Mean QoL in total score on SGRQ (SD): treatment 59 units (13) versus control 56 units (18) Mean RV % predicted (SD): treatment 240% (51) versus control 240% (47) Mean TLC % predicted (SD): treatment 127% (15) versus control 129% (14) Mean DLCO in mm Hg (SD): treatment 9.77 mL/min/mm Hg (3.83) versus control 9.67 mL/min/mm Hg (3.51) Mean PaO2 in mm Hg (SD): treatment 69.3 mm Hg (10.6) versus control 69.7 mm Hg (11.5) Mean PaCO2 in mm Hg (SD): treatment 38.9 mm Hg (4.6) versus control 38.6 mm Hg (5.3) Mean 6MWD in meters (SD): treatment 341 m (108) versus control 360 m (117) |
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| Interventions | Unilateral endobronchial valve placement compared to standard medical care. All participants needed to be on optimal medical care according to GOLD guidelines. | |
| Outcomes | ‐ Forced expiratory volume in one second (FEV1)
‐ 6‐minute walking distance (6MWD) ‐ St. George Respiratory Questionnaire (SGRQ) ‐ Medical Research Council Dyspnea score (MRCD) ‐ Oxygen use ‐ Maximum work load |
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| Notes | Funded by Pulmonx | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not mentioned |
| Allocation concealment (selection bias) | Unclear risk | Independent data and safety monitoring board mentioned, but not enough information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported: more attrition in treatment group but not deemed sufficient enough to influence results |
| Selective reporting (reporting bias) | Low risk | Protocol published |
| Other bias | Unclear risk | Insufficient information provided to permit judgement |