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Conservative versus Interventional Treatment for Spontaneous Pneumothorax

List of authors.
  • Simon G.A. Brown, Ph.D.,
  • Emma L. Ball, F.R.A.C.P.,
  • Kyle Perrin, Ph.D.,
  • Stephen E. Asha, F.A.C.E.M.,
  • Irene Braithwaite, Ph.D.,
  • Diana Egerton-Warburton, M.P.H.,
  • Peter G. Jones, Ph.D.,
  • Gerben Keijzers, Ph.D.,
  • Frances B. Kinnear, Ph.D.,
  • Ben C.H. Kwan, Ph.D.,
  • K.V. Lam, F.R.A.N.Z.C.R.,
  • Y.C. Gary Lee, Ph.D.,
  • Mike Nowitz, F.R.A.N.Z.C.R.,
  • Catherine A. Read, B.Sc.,
  • Graham Simpson, M.D.,
  • Julian A. Smith, F.R.A.C.S.,
  • Quentin A. Summers, D.M.,
  • Mark Weatherall, F.R.A.C.P.,
  • and Richard Beasley, D.Sc.
  • for the PSP Investigators*

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.)

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Funding and Disclosures

Supported by a grant (EMSS-12-190) from the Emergency Medicine Foundation; by Green Lane Research and Education Fund (New Zealand); by grants (11/603 and 18/1002) from the Ministry of Health, New Zealand Health Research Council of New Zealand; by a grant (1084941) from the Department of Health, Australian Government, National Health and Medical Research Council; by the Royal Perth Hospital Research Foundation; and by the State Health Research Advisory Council (Western Australia).

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Dr. Lee reports receiving grant support and supplies from Rocket Medical and advisory board fees from Becton Dickinson/CareFusion. No other potential conflict of interest relevant to this article was reported.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank Graham Simpson, who has challenged the dogma of the current management of primary spontaneous pneumothorax for many years and was pivotal in proposing the rationale for this trial; the patients for their involvement in the trial; and the members of the data and safety monitoring committee: Fraser Brims (Sir Charles Gairdner Hospital, Perth, WA, Australia), Sally Burrows (UWA Medical School, University of Western Australia, Perth, WA, Australia), Kerry Hoggett (Royal Perth Hospital, Perth, WA, Australia), Anthony Lawler (Department of Health, Tasmanian Government, Hobart, TAS, Australia), Mark Little (Cairns Hospital, Cairns, QLD, Australia), Rodolfo Morice (Wellington Hospital, Wellington, New Zealand), Siobhain Mulrennan (Sir Charles Gairdner Hospital, Perth, WA, Australia), Geoffrey Robinson (Wellington Hospital, Wellington, New Zealand), and Grant Waterer (Royal Perth Hospital, Perth, WA, Australia).

Author Affiliations

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.

Address reprint requests to Dr. Brown at the Centre for Clinical Research in Emergency Medicine, Department of Emergency Medicine, Royal Perth Hospital, GPO Box X2213, Perth, WA 6847, Australia, or at .

A complete list of the PSP investigators is provided in the Supplementary Appendix, available at NEJM.org.