Skip to main content
. 2016 Oct 14;2016(10):CD001001. doi: 10.1002/14651858.CD001001.pub3

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
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
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)