VENT US 2010.
| Methods | Randomized clinical trial. 2:1 allocation. Follow‐up until 12 months. | |
| Participants | Baseline Age: treatment 65 years versus control 65 years Participants: treatment n = 220 versus control n = 101 % female: 57% Disease distribution: homogenous and heterogeneous Baseline score on outcomes: Mean FEV1 % predicted (SD): treatment 30% (8) versus control 30% (8) Mean QoL: not reported Mean RV % predicted (SD): treatment 216% (44) versus control 212% (47) Mean TLC % predicted (SD): treatment 124% (15) versus control 125% (16) Mean DLCO in % predicted (SD): treatment 33% (9) versus control 36% (16) Mean PaO2 in mm Hg (SD): treatment 69.1 mm Hg (10.3) versus control 68.4 mm Hg (8.1) Mean PaCO2 in mm Hg (SD): treatment 40.5 mm Hg (4.3) versus control 41.6 mm Hg (4.8) Mean 6MWD in meters (SD): treatment 334 m (87) versus control 351 m (83) |
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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 |
BODE: Body‐mass index, airflow Obstruction, Dyspnea, and Exercise; CAT: COPD assessment test score; COPD: Chronic obstructive pulmonary disease; DLCO: Diffusing capacity of the lungs for carbon monoxide; FDA: US Food and Drug Administration; FEV1: Forced expiratory volume in one second; FVC: Forced vital capacity; Hg: mercury; IQR: Interquartile range; kPa: Kilopascal; mMRC: Modified Medical Research Council (mMRC) Dyspnoea Scale; MRC: Medical Research Council; NIHR: National Institute for Health Research; PaCO2: Partial pressure of carbon dioxide; PaO2: Partial pressure of oxygen; PFT: Pulmonary Function Test; QoL: Quality of life; RV: Residual volume; SD: Standard deviation; SGRQ: St. George's Respiratory Questionnaire; TLC: Total lung capacity; 6MWD: 6‐minute walking distance.