Hillerdal 2005.
| Methods | Randomised controlled trial Method of randomisation: randomised number lists (blocks of 4) Allocation concealment: off‐site, concealed from participants (adequate) Outcome assessor blinding: not described Withdrawals/Dropouts: fully accounted for | |
| Participants | Screened: 304 (eligible: 114)
Randomised: 106 (LVRS 53; control 53)
Completed: 83 (LVRS 42; control 41)
Mean age in years: 62
Diagnosis: CT scan
Emphysema: diffuse
Major exclusions: asthma or bronchitis; smoking; DLCO ≤ 20% predicted age; sequelae of pleurisy/pleural adhesions; long‐term OCS treatment Baseline SGRQ total score in units (SD): 59.1 (13.3) for LVRS vs 58.7 (15.5) for control Shuttle walk in metres (SD): 237 (122) for LVRS vs 198 (104) for control FEV1 in litres (% predicted): 0.72 (26) for LVRS vs 0.69 (27) for control RV in % predicted: 255 for LVRS vs 267 for control TLC in % predicted: 135 for LVRS vs 142 for control PaO2 in kPa: 8.83 for LVRS vs 8.79 for control PaCO2 in kPa: 5.31 for LVRS vs 5.39 for control DLCO: not stated |
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| Interventions | Bilateral LVRS by median sternotomy (N = 42) or video‐assisted thoracoscopy (N = 3) vs continued physical training. Physical training offered to both treatment groups Study duration: participants followed up for 1 year post randomisation |
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| Outcomes | Mortality, lung function, withdrawal, quality of life (SGRQ and SF‐36), exercise capacity (6‐minute walk test and shuttle walk test) | |
| Notes | "Supported by a generous grant from the Swedish Heart‐Lung Foundation" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random numbers table with block randomisation in groups of 4 |
| Allocation concealment (selection bias) | Low risk | Lists kept at the study computer centre, but methods not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Study authors reported, “…randomisation procedure was concealed from the participants,” but it is unclear if the ‘procedure’ refers just to the method of randomisation or actual blinding of participants throughout the study period. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Questionnaires and other data sent to the ‘computer centre’, where secretaries unaware of participants' surgical status ‘processed and fed the data into the computer’ |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition reported |
| Selective reporting (reporting bias) | Unclear risk | Published protocol not available for comparison |
| Other bias | Low risk | No other bias detected |