IMPACT 2016.
Methods | Randomized open‐label one‐way cross‐over RCT. Follow‐up: until 12 months, but only three‐month results published at time of review. | |
Participants | Baseline Age: treatment 64 years versus control 63 years Participants: treatment n = 43 versus control n = 50 % female: 61% Disease distribution: homogenous Baseline score on outcomes: Mean FEV1 % predicted (SD): treatment 28.4% (6.3) versus control 29.9% (6.6) Mean QoL in units total score on SGRQ (SD): treatment 63.2 units (13.7) versus control 59.3 units (15.6) Mean RV % predicted (SD): treatment 277.3% (55.2) versus control 273.7% (63.4) Mean TLC % predicted (SD): treatment 144.9% (21.2) versus control 144.2% (17.6) Mean DLCO % predicted (SD): not reported Mean PaO2 in mm Hg (SD): not reported Mean PaCO2 in mm Hg (SD): not reported Mean 6MWD in meters (SD): treatment 308 m (91) versus control 328 m (93) |
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Interventions | Intervention: Endobronchial valves Control: optimal medical care |
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Outcomes | ‐ Forced expiratory volume in one second (FEV1) ‐ St. George Respiratory Questionnaire (SGRQ) ‐ Residual volume (RV) ‐ 6‐minute walking distance (6MWD) ‐ Modified Medical Research Council (mMRC) dyspnoea score ‐ CAT score ‐ BODE index |
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Notes | "This study was sponsored and funded by Pulmonx Corporation, Redwood City, CA, USA" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization used a blocked design, although a change in randomization blocks happened during the trial |
Allocation concealment (selection bias) | Low risk | Concealed envelopes were used |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Well documented reasons for exclusion, drop‐outs and adverse events |
Selective reporting (reporting bias) | Low risk | NCT02025205 ‐ reported all outcomes |
Other bias | Low risk | None found |