STEP‐UP 2016.
| Methods | Randomized clinical trial. 2:1 allocation via block randomization. Follow‐up until 6 months. | |
| Participants | Baseline Age: treatment 64 years versus control 63 years Participants: treatment n = 46 versus control n = 24 % female: 52% Disease distribution: heterogeneous Baseline score on outcomes: Mean FEV1 % predicted (SD): treatment 33.8% (8.2) versus control 33.7% (8.8) Mean QoL in units total score on SGRQ (SD): treatment 57.7 units (15) versus control 57.3 units (20) Mean RV % predicted (SD): treatment 235% (40.3) versus control 243% (45.1) Mean TLC % predicted (SD): treatment 135.9% (14.6) versus control 136.8% (16.9) Mean DLCO (SD): not reported Mean PaO2 (SD): not reported Mean PaCO2 (SD): not reported Mean 6MWD in meters (SD): treatment 356 m (92) versus control 370 m (111.5) |
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| Interventions | Treatment with vapour ablation versus optimal medical care in concordance with GOLD. | |
| Outcomes | ‐ Forced expiratory volume in one second (FEV1) ‐ St. George Respiratory Questionnaire (SGRQ) ‐ Adverse events ‐ Other pulmonary function test parameters ‐ 6‐minute walking distance (6MWD) |
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| Notes | Funded by Uptake Medical | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Blinded blocked randomization scheme separated by site |
| Allocation concealment (selection bias) | Unclear risk | Blinding mentioned but no specifics reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Open label, no mentioning of outcome assessment blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported: balanced between groups |
| Selective reporting (reporting bias) | Low risk | Protocol published |
| Other bias | Low risk | No other risk of bias found |