Harvey 1994.
Methods |
Country: United Kingdom Design: randomized controlled trial Objective: to assess acceptability and outcomes of a randomized comparison of simple aspiration vs intercostal drainage at 1 year Study site for recruitment: patients presenting to hospital Method of analysis: not reported, although logistical regression was used to measure association with failed aspiration; intention‐to‐treat data reported |
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Participants |
Eligible for study: not reported Randomized: aspiration n = 35; tube drainage n = 38 Completed: aspiration n = 35; tube drainage n = 38 Age: aspiration mean 34.6 ± 15.0; tube drainage mean 34.6 ± 13.1 Gender: aspiration male n = 28, female n = 7; tube drainage male n = 29, female n = 9 Diagnosis criteria: patients presenting with spontaneous pneumothorax for whom the admitting team thought a drainage procedure was required Recruitment: not specifically reported, although participants presenting with spontaneous pneumothorax were randomized to either group Diseases included: not reported Reasons for patient exclusion: patients with signs of tension pneumothorax or with lung disease other than previous pneumothorax Reasons for patient inclusion: patients presenting with spontaneous pneumothorax for whom the admitting team thought a drainage procedure was required Baseline values: aspiration: previous pneumothorax n = 6; radiographic appearance: left side n = 13/30; size: small rim n = 3, partial collapse n = 16, complete collapse n = 10 Tube drainage: previous pneumothorax n = 8; radiographic appearance: left side n = 12/32; size: small rim n = 1, partial collapse n = 12, complete collapse n = 18 |
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Interventions |
Setting: not specifically reported, hospital setting assumed Aspiration description: undertaken by inserting a 16‐ to 18‐gauge catheter under local anaesthetic and aspirating air through a 3‐way tap with the exit tube under water; procedure continued until no more air could be aspirated, participant became uncomfortable, or maximum of 3 litres had been removed Chest tube description: managed according to the participating physician’s usual practice; no sclerosing drugs allowed with either technique |
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Outcomes |
Prespecified outcomes: (1) pain experienced during procedure; (2) length of hospital stay; (3) procedure success; (4) recurrence; (5) procedure failure Follow‐up period: 12 months |
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Notes | No information on funding provided | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization reported but method not described |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors not blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Intention‐to‐treat analysis performed; no attrition mentioned; however, information insufficient to permit a judgement |
Selective reporting (reporting bias) | Unclear risk | Information insufficient to permit a judgement |
Other bias | Unclear risk | Information insufficient to permit a judgement |