Stammberger 2000.
| Methods | Randomised controlled trial Method of randomisation: not described Allocation concealment: not clear Blinding of assessors: not described | |
| Participants | Screened: not reported
Randomised: 74 (65 analysed: buttressed group 32; non‐buttressed group 33)
Completed: 65 (LVRS 32; control 33)
Mean age in years: 60
Diagnosis: CT scan
Entry criteria: radiological evidence of emphysema; breathlessness leading to impaired quality of life; consent; FEV1 < 35% predicted; optimal medical therapy; candidature for lung transplantation
Major exclusions: current smoker; > 75 years; 'vanishing lung' on CT; TLCO < 20% predicted; hypercapnia; pulmonary hypertension; bronchiectasis; chest infection; OCS therapy > 15 mg/d Baseline QoL: not tested 6MWD: not tested FEV1 in litres (% predicted): 0.77 (27) for buttressing vs 0.76 (27) for control RV in % predicted: 287 for LVRS vs 284 for control TLC in L (% predicted): 8.15 (139) for buttressing vs 8.45 (138) for control PaO2 in mmHg: 65.3 for LVRS vs 64.2 for control PaCO2 in mmHg: 40.1 for LVRS vs 41.3 for control DLCO: not stated |
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| Interventions | Buttressed vs non‐buttressed stapling device in LVRS procedures Pulmonary rehabilitation not undertaken as part of study protocol |
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| Outcomes | Length of hospital stay; FEV1; dyspnoea; PaO2 and PaCO2; complications; mortality | |
| Notes | "Supported by grant 3200‐043358;95.1 from the Swiss National Science Fund and by a grant from the Zurich Lung League" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as randomised; other information not available |
| Allocation concealment (selection bias) | Unclear risk | Unclear ‐ no mention of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention of attempted blinding for participants |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding for outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Missing outcome data not mentioned |
| Selective reporting (reporting bias) | Unclear risk | No online protocol available |
| Other bias | Low risk | No other biases identified |
6MWD: 6‐minute walk distance; ATS: American Thoracic Society; BMI: body mass index; CRDQ/CRQ: Chronic Respiratory Disease Questionnaire; CS: corticosteroid; CT: computed tomography; DLCO: diffusing capacity of the lungs for carbon monoxide; FEV1: forced expiratory volume in one second; FiO2: fraction of inspired oxygen; FRC: functional residual capacity; FVC: forced expiratory vital capacity; HUI: Health Utilities Index; IQR: interquartile range; LTOT: long‐term oxygen therapy; LVRS: lung volume reduction surgery; mmHg: millimetres of mercury; MS: median sternotomy; MOS‐36: Medical Outcomes Study‐36 questionnaire; MRC: Medical Research Council breathlessness scale; NYHA: New York Heart Association; OCS: oral corticosteroids; PaCO2: partial pressure of carbon dioxide; PaO2: partial pressure of oxygen; PR: pulmonary rehabilitation; QALY: quality‐adjusted life‐year; QoL: quality of life; RV: residual volume; SD: standard deviation; SGRQ: St George's Respiratory Questionnaire; SF‐36: Short‐Form 36 questionnaire; TLC: total lung capacity; TLCO: transfer factor for carbon monoxide; VP: ventilation/perfusion; V/Q scan: ventilation/perfusion scan; VATS: video‐assisted thoracic surgery.