IBV Valve trial 2014.
| Methods | Randomized clinical trial. 1:1 allocation. Not sufficient information to permit judgement on allocation concealment. Follow‐up until 6 months. | |
| Participants | Baseline Age: treatment 65 years versus control 65 years Participants: treatment n = 142 versus control n = 135 % female: 43% Disease distribution: heterogeneous Baseline score on outcomes: Mean FEV1 % predicted (SD): treatment 29.8% (7.5) versus control 29.7% (7.9) Mean QoL in units total score on SGRQ (SD): treatment 54.8 units (15.5) versus control 57.1 units (15.2) Mean RV % predicted (SD): treatment 216.0% (50.1) versus control 215.8% (55.9) Mean TLC % predicted (SD): treatment 128.1% (15.9) versus control 128.2% (19.8) Mean DLCO % predicted (SD): treatment 36.4% (12.7) versus control 35.0% (13.1) Mean PaO2 in mm Hg (SD): treatment 67.8 mm Hg (11.3) versus control 67.0 mm Hg (10.7) Mean PaCO2 in mm Hg (SD): treatment 39.8 mm Hg (5.3) versus control 40.8 mm Hg (4.8) Mean 6MWD in meters (SD): treatment 314.1 m (88.6) versus control 308.6 m (81.6) |
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| Interventions | Partial bilateral placement of Intrabronchial valves compared to sham control | |
| Outcomes | ‐ St. George Respiratory Questionnaire (SGRQ) ‐ Lobar volume changes ‐ Pulmonary function tests ‐ Short Form‐36 ‐ 6‐minute walking distance (6MWD) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment mentioned but not specified |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | " If the patient was randomized to control, a catheter was passed into the target airways and a script read out loud indicating (sham) valve deployment." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | A separate team without knowledge of the group assignment provided follow‐up evaluations to maintain blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition mentioned: more attrition in treatment group but not deemed sufficient to influence results |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. No protocol published. |
| Other bias | Low risk | No other risk of bias found |