BeLieVeR HIFi 2015.
| Methods | Randomized clinical trial. 1:1 block randomizations stratified by study site. Masking maintained by working with two separate teams. Follow‐up until 3 months. | |
| Participants | Baseline Age: treatment 62 years versus control 63 years Participants: treatment n = 25 versus control n = 25 % female: 38% Disease distribution: heterogeneous Baseline score on outcomes: Mean FEV1 % predicted (SD): treatment 31.6% (10.2) versus control 31.8% (10.5) Mean QoL in units total score on SGRQ (SD): treatment 67.79 units (13.17) versus control 70.65 units (12.48) Mean RV % predicted (SD): treatment 219% (39) versus control 245% (44) Mean TLC % predicted (SD): treatment 132% (12) versus control 142% (15) Mean DLCO % predicted (SD): treatment 33.8% (10.8) versus control 33.7% (44) Mean PaO2 in kPa (SD): treatment 9.74 kPa (1.45) versus control 9.47 kPa (0.89) Mean PaCO2 in kPa (SD): treatment 4.81 kPa (0.86) versus control 4.90 kPa (0.61) Mean 6MWD in meters (SD): treatment 342 m (94) versus control 334 m (81) |
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| Interventions | Treatment: unilateral valve placement. Control: sham valve placement |
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| Outcomes | ‐ Percentage change in post‐bronchodilator
FEV1 measured 90 days post procedure ‐ Change in endurance (change in 6MWD) ‐ Change in COPD assessment Test (CAT) ‐ Change in St. George Respiratory Questionnaire (SGRQ) |
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| Notes | Funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC‐NIHR partnership. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "predetermined block randomisation, with a block size of 10, computer‐generated by the trial statistician" |
| Allocation concealment (selection bias) | Low risk | "Masking was maintained by having two separate teams: one which undertook the randomized procedures and a separate team, masked to study assignment, responsible for recruitment and the assessments " |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Involved sham procedure so participants were blinded. Not possible to blind the proceduralist |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessment was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported: balanced between groups |
| Selective reporting (reporting bias) | Low risk | Low: protocol published |
| Other bias | Low risk | No other risk of bias found |