Health technology assessment: time for a randomised controlled trial of the role of lung volume reduction surgery in the treatment of emphysema. The Lung Volume Reduction Surgery Trial Project Team

IntroductionAlthough lung volume reduction surgery and bronchoscopic lung volume reduction with endobronchial valves have both been shown to improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema, there are no direct comparison data between the two procedures to inform clinical decision-making.Methods and analysisWe describe the protocol of the CELEB study, a randomised controlled trial which will compare outcomes at 1 year between the two procedures, using a composite disease severity measure, the iBODE score, which includes body mass index, airflow obstruction, dyspnoeaand exercise capacity (incremental shuttle walk test).Ethics and disseminationEthical approval to conduct the study has been obtained from the Fulham Research Ethics Committee, London (16/LO/0286). The outcome of this trial will provide information to guide treatment choices in this population and will be presented at national and international meetings and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter.Trial registration numberISRCTN19684749; Pre-results.

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Equipoise and the Ethics of the Canadian Lung Volume Reduction Surgery Trial study: Should There Be a Randomized, Controlled Trial to Evaluate Lung Volume Reduction Surgery?

Canadian Respiratory Journal ◽

10.1155/2000/853215 ◽

2000 ◽

Vol 7 (4) ◽

pp. 329-332 ◽

Cited By ~ 6

Author(s):

John D Miller ◽

Michael D Coughlin ◽

Lori Edey ◽

Patricia Miller ◽

Yasmin Sivji

Keyword(s):

Randomized Controlled Trial ◽

Lung Volume ◽

Controlled Trial ◽

Volume Reduction ◽

Three Dimensions ◽

Clinical Equipoise ◽

Lung Volume Reduction Surgery ◽

Lung Volume Reduction ◽

Randomized Controlled ◽

Surgery Trial

The physical improvement is so great following lung volume reduction surgery that there is growing opinion that a randomized, controlled trial is unnecessary. A randomized, controlled trial, it is argued, would deprive those patients randomly assigned to the nonsurgical treatment arm the 'benefit' of lung volume reduction surgery. Entering a trial in which one arm leads to a surgical intervention and the other to best medical management also poses a variety of ethical difficulties. If one is to be offered surgery, there must be perceived benefit because the physician has an obligation to offer the best possible treatment for his or her patient. If a patient agrees to have surgery, the expectation is that surgery would help. Thus, a patient randomly assigned to the medical arm of a trial may easily believe that he or she is being deprived of surgery that may help them. This paper illustrates this dilemma using the Canadian Lung Volume Reduction Surgery Trial. The authors discuss the concept of 'equipoise' in three dimensions, adding community equipoise to theoretical equipoise and clinical equipoise earlier described by Freedman. The paper concludes that the Canadian Lung Volume Reduction Surgery Trial needs to continue because of the clinical equipoise that drives it.

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