Goldstein 2003.
Methods | Randomised controlled trial Method of randomisation: random numbers table, block randomisation in groups of 4 Allocation concealment: adequate Outcome assessor blinding: described Withdrawals/Dropouts: fully accounted for | |
Participants | Screened: 328
Randomised: 55 (LVRS 28, control 27) Completed: 50 (LVRS 24, control 26) Mean age in years: 65 Diagnosis: CT or V/Q scan Emphysema: heterogeneous distribution Entry criteria: < 75 years; FEV1 < 40% predicted; TLC > 120% predicted; evidence of heterogenous emphysema on CT or V/Q scan Exclusion criteria: asthma; prior lung surgery; pleural disease; contraindications for surgery; inability to attend PR or follow‐up; pulmonary hypertension Baseline QoL: not reported (SF‐36 administered to participants, but not reported on) 6‐minute walk in metres (SE): 387 (15) for LVRS vs 372 (17) for control FEV1 in litres (% predicted): 0.8 (33) for LVRS vs 0.7 (32) for control RV in % predicted: 228 for LVRS vs 253 for control TLC in % predicted: 142 for LVRS vs 155 for control PaO2: not stated PaCO2: not stated DLCO: not stated |
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Interventions | LVRS via video‐assisted thoracic surgery (VATS) (or less often by median sternotomy at the discretion of the surgeon) vs ongoing medical treatment including pulmonary rehabilitation. A short course of pulmonary rehabilitation was offered to participants in the surgery group. Pulmonary rehabilitation: 6‐week programme with supervised physical exercise, educational and psychosocial components Outcomes assessed at 3, 6, 9 and 12 months after randomisation |
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Outcomes | Quality of life (measured by the CRDQ); 6‐minute walking distance, submaximal cycle endurance time; FEV1; FEV1/FVC; RV; FRC; TLC; mortality | |
Notes | "This study was supported, in part, by the Physician's Services Incorporated Foundation (Ontario, Canada) and by West Park Healthcare Centre Foundation." | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table, block randomisation in groups of 4 |
Allocation concealment (selection bias) | Low risk | Study authors reported that allocation was concealed, with the physician and surgeon remaining unaware of the arm to which the participant would be allocated; however, they did not describe methods. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | LVRS does not lend itself to blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research assistants who were blind to the participant's group allocation conducted all outcome assessments at 3, 6, 9 and 12 months after randomisation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data due to treatment complications displayed graphically; attrition also reported |
Selective reporting (reporting bias) | Unclear risk | Protocol was not available for comparison. |
Other bias | High risk | Possible selective recruitment, as participants were referred by respiratory physicians, and a physician and a surgeon reassessed those wishing to proceed and made the final decision regarding eligibility; no other information was provided. Furthermore, no sham‐surgery group, which might lead to some placebo effects (as mentioned by study authors) |