Simon G A Brown1, Emma L Ball1, Kyle Perrin1, Stephen E Asha1, Irene Braithwaite1, Diana Egerton-Warburton1, Peter G Jones1, Gerben Keijzers1, Frances B Kinnear1, Ben C H Kwan1, K V Lam1, Y C Gary Lee1, Mike Nowitz1, Catherine A Read1, Graham Simpson1, Julian A Smith1, Quentin A Summers1, Mark Weatherall1, Richard Beasley1. 1. From the Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Royal Perth Hospital, and the University of Western Australia (S.G.A.B., E.L.B., C.A.R.), Royal Perth Hospital Imaging (K.V.L.) and the Respiratory Department (E.L.B., Q.A.S.), Royal Perth Hospital, the Department of Respiratory Medicine, Sir Charles Gairdner Hospital (Y.C.G.L.), and the Centre for Respiratory Health, School of Medicine and Pharmacology, University of Western Australia (Y.C.G.L.), Perth, Aeromedical and Retrieval Services, Ambulance Tasmania (S.G.A.B.), and the Department of Respiratory Medicine, Royal Hobart Hospital (E.L.B.), Hobart, the Emergency Department, St. George Hospital, Kogarah, NSW (S.E.A.), St. George Clinical School, Faculty of Medicine, University of New South Wales, Kensington (S.E.A., B.C.H.K.), the Emergency Department, Monash Medical Centre (D.E.-W.), the Departments of Medicine (D.E.-W.) and Surgery (J.A.S.), School of Clinical Sciences at Monash Health, Monash University, and the Department of Cardiothoracic Surgery, Monash Health (J.A.S.), Clayton, VIC, the Emergency Department, Gold Coast Health Service District, the School of Medicine, Bond University, and the School of Medicine, Griffith University, Gold Coast, QLD (G.K.), Emergency Medical and Children's Services, Prince Charles Hospital, Chermside, QLD (F.B.K.), the University of Queensland, Brisbane (F.B.K.), the Department of Respiratory and Sleep Medicine, Sutherland Hospital, Sydney (B.C.H.K.), and the Department of Respiratory Medicine, Cairns Hospital, Cairns, QLD (G.S.) - all in Australia; the Medical Research Institute of New Zealand (K.P., I.B., M.W., R.B.), the Capital and Coast District Health Board (K.P., M.W., R.B.), and Pacific Radiology (M.N.), Wellington, and the Adult Emergency Department, Auckland City Hospital and University of Auckland, Auckland (P.G.J.) - all in New Zealand.
Abstract
BACKGROUND: Whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax is unknown. METHODS: 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. RESULTS: A total of 316 patients underwent randomization (154 patients to the intervention group and 162 to the conservative-management group). In the conservative-management 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. CONCLUSIONS: 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. (Funded by the Emergency Medicine Foundation and others; PSP Australian New Zealand Clinical Trials Registry number, ACTRN12611000184976.).
RCT Entities:
BACKGROUND: Whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax is unknown. METHODS: 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. RESULTS: A total of 316 patients underwent randomization (154 patients to the intervention group and 162 to the conservative-management group). In the conservative-management 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. CONCLUSIONS: 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. (Funded by the Emergency Medicine Foundation and others; PSP Australian New Zealand Clinical Trials Registry number, ACTRN12611000184976.).
Authors: Nathan M Money; Alan R Schroeder; Ricardo A Quinonez; Timmy Ho; Jennifer R Marin; Elizabeth R Wolf; Daniel J Morgan; Sanket S Dhruva; Eric R Coon Journal: Pediatrics Date: 2022-02-01 Impact factor: 7.124
Authors: Rob J Hallifax; Edward McKeown; Parthipan Sivakumar; Ian Fairbairn; Christy Peter; Andrew Leitch; Matthew Knight; Andrew Stanton; Asim Ijaz; Stefan Marciniak; James Cameron; Amrithraj Bhatta; Kevin G Blyth; Raja Reddy; Marie-Clare Harris; Nadeem Maddekar; Steven Walker; Alex West; Magda Laskawiec-Szkonter; John P Corcoran; Stephen Gerry; Corran Roberts; John E Harvey; Nick Maskell; Robert F Miller; Najib M Rahman Journal: Lancet Date: 2020-07-04 Impact factor: 79.321