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. 2017 Sep 7;2017(9):CD004479. doi: 10.1002/14651858.CD004479.pub3

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
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
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
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
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