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 |
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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 |