RENEW 2016.
| Methods | Randomized clinical trial. 1:1 allocation via block randomization stratified per emphysema type. Follow‐up until 12 months. | |
| Participants | Baseline Age: treatment 63 years versus control 64 years Participants: treatment n = 158 versus control n = 157 % female: 52.4% Disease distribution: both Baseline score on outcomes: Mean FEV1 % predicted (SD): treatment 25.7% (6.3) versus control 26.3% (6.7) Mean QoL in units total score on SGRQ (SD): treatment 60.1 units (12.8) versus control 57.4 units (14.8) Mean RV % predicted (SD): treatment 245.9% (39.1) versus control 244.5% (38.7) Mean TLC % predicted (SD): treatment 139.2% (15.6) versus control 138.8% (16.1) Mean DLCO % predicted (SD): treatment 34.1% (10.5) versus control 34.5% (10.7) Mean PaO2 in mm Hg (SD): treatment 41.6 mm Hg (5.6) versus control 41.5 mm Hg (5.3) Mean PaCO2 in mm Hg (SD): treatment 68.0 mm Hg (10.5) versus control 69.2 mm Hg (10.9) Mean 6MWD in meters (SD): treatment 312.0 m (79.1) versus control 302.7 m (79.3) |
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| Interventions | Treatment with endobronchial coils versus standard medical care. All participants needed to be treated according to GOLD criteria. | |
| Outcomes | ‐ 6‐Minute Walking distance (6MWD) ‐ Forced expiratory volume in one second (FEV1) ‐ St George’s Respiratory Questionnaire (SGRQ) ‐ Pulmonary function test parameters ‐ Adverse events |
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| Notes | RENEW was supported by PneumRx Inc, a BTG International group company. Drs Sciurba, Criner, and Slebos received institutional support from Pulmonx. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Blinded block randomization (block size of 4) stratified by type of emphysema |
| Allocation concealment (selection bias) | Unclear risk | Unsufficient information 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 | High risk | Only walk and spirometry was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported: balanced between groups |
| Selective reporting (reporting bias) | Low risk | Protocol added in supplement and trial registered at clinicaltrials.gov: NCT01608490 |
| Other bias | Low risk | No risk of other bias detected |