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Title: | Conservative versus interventional treatment for spontaneous pneumothorax. | Authors: | Ball E.L.;Kwan B.C.H.;Lam K.V.;Lee Y.C.G.;Nowitz M.;Read C.A.;Simpson G.;Smith J.A. ;Summers Q.A.;Weatherall M.;Beasley R.;Keijzers G.;Jones P.G.;Egerton-Warburton D. ;Braithwaite I.;Asha S.E.;Kinnear F.B.;Brown S.G.A.;Perrin K. | Monash Health Department(s): | Cardiothoracic Surgery | Institution: | (Brown, Ball, Read) Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Royal Perth Hospital, University of Western Australia, Australia (Lam) Royal Perth Hospital Imaging, Australia (Ball) Respiratory Department, Royal Perth Hospital, Australia (Lee, Summers) Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Australia (Lee) Centre for Respiratory Health, School of Medicine and Pharmacology, University of Western Australia, Australia (Brown) Perth, Aeromedical and Retrieval Services, Ambulance Tasmania, Australia (Ball) Department of Respiratory Medicine, Royal Hobart Hospital, Hobart, Australia (Asha) Emergency Department, St. George Hospital, Kogarah, NSW, Australia (Asha, Kwan) St. George Clinical School, Faculty of Medicine, University of New South Wales, Kensington, Australia (Egerton-Warburton) Emergency Department, Monash Medical Centre, Australia (Egerton-Warburton) Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Australia (Smith) Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Australia (Smith) Department of Cardiothoracic Surgery, Monash Health, Clayton, VIC, Australia (Keijzers) Emergency Department, Gold Coast Health Service District, School of Medicine, Bond University, School of Medicine, Griffith University, Gold Coast, QLD, Australia (Kinnear) Emergency Medical and Children's Services, Prince Charles Hospital, Chermside, QLD, Australia (Kinnear) University of Queensland, Brisbane, Australia (Kwan) Department of Respiratory and Sleep Medicine, Sutherland Hospital, Sydney, Australia (Simpson) Department of Respiratory Medicine, Cairns Hospital, Cairns, QLD, Australia (Perrin, Braithwaite, Weatherall, Beasley) Medical Research Institute of New Zealand, New Zealand (Perrin, Weatherall, Beasley) Capital and Coast District Health Board (Nowitz) Pacific Radiology, Wellington, New Zealand (Jones) Adult Emergency Department, Auckland City Hospital, University of Auckland, Auckland, New Zealand | Issue Date: | 17-Feb-2020 | Copyright year: | 2020 | Publisher: | Massachussetts Medical Society | Place of publication: | United States | Publication information: | New England Journal of Medicine. 382 (5) (pp 405-415), 2020. Date of Publication: 30 Jan 2020. | Journal: | New England Journal of Medicine | Abstract: | Background: Whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax is unknown. Method(s): In this open-label, multicenter, noninferiority trial, we recruited patients 14 to 50 years of age with a first-known, unilateral, moderate-to-large primary spontaneous pneumothorax. Patients were randomly assigned to immediate interventional management of the pneumothorax (intervention group) or a conservative observational approach (conservative-management group) and were followed for 12 months. The primary outcome was lung reexpansion within 8 weeks. Result(s): A total of 316 patients underwent randomization (154 patients to the intervention group and 162 to the conservative-management group). In the conservativemanagement group, 25 patients (15.4%) underwent interventions to manage the pneumothorax, for reasons prespecified in the protocol, and 137 (84.6%) did not undergo interventions. In a complete-case analysis in which data were not available for 23 patients in the intervention group and 37 in the conservative-management group, reexpansion within 8 weeks occurred in 129 of 131 patients (98.5%) with interventional management and in 118 of 125 (94.4%) with conservative management (risk difference, -4.1 percentage points; 95% confidence interval [CI], -8.6 to 0.5; P = 0.02 for noninferiority); the lower boundary of the 95% confidence interval was within the prespecified noninferiority margin of -9 percentage points. In a sensitivity analysis in which all missing data after 56 days were imputed as treatment failure (with reexpansion in 129 of 138 patients [93.5%] in the intervention group and in 118 of 143 [82.5%] in the conservative-management group), the risk difference of -11.0 percentage points (95% CI, -18.4 to -3.5) was outside the prespecified noninferiority margin. Conservative management resulted in a lower risk of serious adverse events or pneumothorax recurrence than interventional management. Conclusion(s): Although the primary outcome was not statistically robust to conservative assumptions about missing data, the trial provides modest evidence that conservative management of primary spontaneous pneumothorax was noninferior to interventional management, with a lower risk of serious adverse events.Copyright © 2020 Massachusetts Medical Society. | DOI: | http://monash.idm.oclc.org/login?url=http://acs.hcn.com.au/?acc=36265&url=http://dx.doi.org/10.1056/NEJMoa1910775 | PubMed URL: | 31995686 [http://www.ncbi.nlm.nih.gov/pubmed/?term=31995686] | ISSN: | 0028-4793 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/29374 | Type: | Article | Subjects: | priority journal randomized controlled trial recurrent disease risk assessment scar/co [Complication] sensitivity analysis skin infection/co [Complication] skin manifestation/si [Side Effect] *spontaneous pneumothorax/su [Surgery] *spontaneous pneumothorax/th [Therapy] tension pneumothorax/co [Complication] thorax pain/co [Complication] treatment failure chlorhexidine/ae [Adverse Drug Reaction] chest tube/am [Adverse Device Effect] article adolescent adult adverse event atelectasis/co [Complication] bleeding/co [Complication] clinical observation clinical outcome consciousness disorder/co [Complication] *conservative treatment controlled study coughing/co [Complication] disease severity dyspnea/co [Complication] emphysema/co [Complication] empyema/co [Complication] female follow up foreign body/co [Complication] hematothorax/co [Complication] Horner syndrome/co [Complication] human hypotension/co [Complication] intermethod comparison intervention study lung edema/co [Complication] major clinical study male medical device complication/co [Complication] multicenter study open study paresthesia/co [Complication] recurrent disease scar/co skin infection/co skin manifestation spontaneous pneumothorax tension pneumothorax/co thorax pain/co chlorhexidine chest tube/am [Adverse Device Effect] adverse event atelectasis/co clinical observation consciousness disorder/co conservative treatment coughing/co dyspnea/co emphysema/co empyema/co foreign body/co hematothorax/co Horner syndrome/co hypotension/co intermethod comparison intervention study lung edema/co medical device /co paresthesia/co controlled study coughing / complication disease severity dyspnea / complication emphysema / complication empyema / complication female follow up foreign body / complication hematothorax / complication Horner syndrome / complication human hypotension / complication intermethod comparison intervention study lung edema / complication major clinical study medical device complication / complication multicenter study open study paresthesia / complication priority journal randomized controlled trial recurrent disease risk assessment scar / complication sensitivity analysis skin infection / complication skin manifestation / side effect *spontaneous pneumothorax / *surgery / *therapy tension pneumothorax / complication thorax pain / complication treatment failure adolescent adult male adverse event Article atelectasis / complication bleeding / complication clinical observation clinical outcome consciousness disorder / complication *conservative treatment |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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