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. 2016 Oct 14;2016(10):CD001001. doi: 10.1002/14651858.CD001001.pub3

McKenna 1996.

Methods Randomised controlled trial of 2 interventions
 Method of randomisation: not described
 Allocation concealment: not described
 Outcome assessor blinding: not blinded
 Withdrawals/Dropouts: fully accounted for
Participants Screened: not stated
 Eligible: 72
 Randomised: 72 (laser 33; staple 39)
 Completed: 62 (laser 26; staple 36)
 Mean age in years (SD): 67 (7)
 Diagnosis: CT scan
 Emphysema: diffuse, heterogeneous, bullae < 5 cm
 Diseases included: not stated
 Major exclusions: smoking, no prior thoracic surgery, age > 75 years, CO2 retention > 55 mmHg, severe cardiac disease, cancer within the past 5 years, ventilator dependency, presence of a lung mass, bullae > 5 cm
Baseline
SF‐36: not stated
 6MWD (SD): not tested
FEV1 in litres (SD): 0.7 (0.2) for laser vs 0.7 (0.2) for staple
RV in litres (SD): 5.1 (1.1) for laser vs 5.4 (0.2) for staple
TLC in litres (SD): 7.6 (1.4) for laser vs 7.9 (1.3) for staple
PaO2 in mmHg: 65 for laser vs 66 for staple
 PaCO2 in mmHg: 43 for laser vs 44 for staple
DLCO in mL/min/mmHg: 5.4 for laser vs 8.6 for staple
Interventions Laser 
 Extent: bilateral/unilateral ‐ unsure
 Approach: thoracoscipic
 Resection method: Nd: YAG (neodymium yttrium‐aluminium‐garnet laser)
 Non‐surgical: postop pulmonary rehab continued for 2 to 3 weeks after discharge
 Medications: not clear
 Stapling 
 Extent: unilateral
 Approach: thoracoscipic
 Resection method: stapling with bovine pericardium reinforcement
 Non‐surgical: postoperative pulmonary rehabilitation continued for 2 to 3 weeks after discharge
 Medications: not clear
 Other: All participants in both groups were educated and were encouraged to join a Better Breathers Club.
Outcomes Morbidity, air leaks, delayed pneumothorax, FEV1, MOS‐36, operation time (hours), length of stay, supplemental oxygen therapy, repiratory failure
Notes "Supported in part by Department of Education grant DEf603‐ 91 ER61227 and National Institutes of Health grant R01192"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation mentioned but methods not described
Allocation concealment (selection bias) Unclear risk Unclear ‐ Study authors mention that “…patients were blindly randomized…”, but methods were not described.
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 Unclear risk No mention of blinding of outcome assessors
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Methods of handling outcome data missing from questionnaires (if any) not described
Selective reporting (reporting bias) Unclear risk Prespecified published protocol not available for comparison
Other bias Low risk No other biases identified