Clarenbach 2015.
Methods | Randomised controlled trial Method of randomisation: not described Allocation concealment: performed via opaque envelopes Outcome assessor blinding: not described Withdrawals/Dropouts: fully accounted for | |
Participants | Screened: 40
Randomised: 30 Completed: 27 (LVRS 14; control 13) Mean age in years: 63 Diagnosis: CT scan Emphysema: heterogeneous and homogenous Diseases included: not stated Entry criteria (similar to NETT): FEV1 ≤ 45% predicted (≥ 15% predicted among participants ≥ 70 years of age); TLC ≥ 100% predicted; RV ≥ 150% predicted; partial pressure of resting arterial carbon dioxide ≤ 60 mmHg; resting partial pressure of arterial oxygen ≥ 45 mm Hg; ability to walk ≥ 140 metres (m) in 6 minutes; ability to complete 3 minutes on bicycle ergometer; abstinence from smoking for 6 months before randomisation Exclusion criteria: concurrent medical conditions precluding surgery or that might interrupt follow‐up Baseline QoL: not stated 6‐minute walk, metres: 326 for LVRS vs 287 for control FEV1 in % predicted (SD): 27.8 (7.2) for LVRS vs 26.2 (5.9) for control RV: not stated TLC in % predicted (SD): 124.5 (9.1) for LVRS vs 137.2 (19.8) for control PaO2: not stated PaCO2: not stated DLCO median % predicted (IQR): 35 (27 to 39) for LVRS vs 33 (31 to 38) for control |
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Interventions | CT scan and perfusion scintigraphy were used to determine the target area, after which surgery was conducted via VATS. For participants with homogenous emphysema, LVRS was performed in the upper lobes. | |
Outcomes | ‐ Assessment of endothelial function by FMD ‐ Determination of systemic inflammation ‐ Blood pressure and heart rate ‐ Daily physical activity and physical activity level ‐ Exercise capacity ‐ Lung function values including FEV1, FVC, RV, DLCO % predicted |
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Notes | Support was received from "Lunge Zurich." | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation was mentioned, but methods were not described. |
Allocation concealment (selection bias) | Low risk | "Allocation concealment was performed by the use of sealed envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | LVRS does not permit blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "All measurements were analyzed by one examiner, who was blinded to the randomization protocol (M.K.)." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was reported. |
Selective reporting (reporting bias) | Unclear risk | No protocol was published, but trial was registered at Clinicaltrials.gov: NCT 01020344. Data analysis was performed on a per‐protocol basis. |
Other bias | Low risk | No evidence of contamination was found other than that reported above, but post hoc analysis was performed to adjust for imbalance in baseline characteristics. |