Reply

Abstract

My colleagues and I would like to thank Ms Chen and Dr Eltorai for their letter to the editor [1Chen J. Eltorai A.E.M. Incentive spirometry after lung resection: the importance of patients’ adherence (letter).Ann Thorac Surg. 2019; 107: 985Abstract Full Text Full Text PDF Scopus (4) Google Scholar] commenting on our recent clinical trial evaluating incentive spirometry (IS) after lung resection [2Malik P.R.A. Fahim C. Vernon J. et al.Incentive spirometry after lung resection: a randomized controlled trial.Ann Thorac Surg. 2018; 106: 340-345Abstract Full Text Full Text PDF Scopus (15) Google Scholar]. Ms Chen and Dr Eltorai [1Chen J. Eltorai A.E.M. Incentive spirometry after lung resection: the importance of patients’ adherence (letter).Ann Thorac Surg. 2019; 107: 985Abstract Full Text Full Text PDF Scopus (4) Google Scholar] propose that the conclusions from our trial may not be valid, and only a trial that enforces and evaluates adherence can draw conclusions on clinical effectiveness of IS after lung resection. Although we are in complete agreement with Ms Chen and Dr Eltorai [1Chen J. Eltorai A.E.M. Incentive spirometry after lung resection: the importance of patients’ adherence (letter).Ann Thorac Surg. 2019; 107: 985Abstract Full Text Full Text PDF Scopus (4) Google Scholar]s on the matter that outcomes of usage of medical devices are highly correlated with adherence, we share a difference of opinion on how pragmatic clinical trials should be designed. Simply put, let us assume that we design a rigid trial that enforces and measures adherence to the IS device and find that it actually improves outcomes. If we are subsequently unable to convince patients to use it in the real world, then we would have proved that a device works in the context of a clinical trial but would have no information on whether it is actually clinically useful. Pragmatic trials can circumvent this methodologic flaw by trying to measure the effectiveness of treatments in a simulation of what may happen in the real-world environment. In our particular case, we sought to determine how IS affects patients’ outcomes when we simulate real-world conditions: give IS to them, explain it to them, encourage them to use it, and hope that they do. Our conclusions demonstrate that in the era of enhanced recovery pathways, in patients with lung cancer, and in a real-world environment, IS offers no reduction in postoperative pulmonary complications. We also agree with Ms Chen and Dr Eltorai [1Chen J. Eltorai A.E.M. Incentive spirometry after lung resection: the importance of patients’ adherence (letter).Ann Thorac Surg. 2019; 107: 985Abstract Full Text Full Text PDF Scopus (4) Google Scholar] on the issue of measuring atelectasis and its severity, and we believe that our trial has done what they suggest we should have done. Atelectasis on its own, detected on chest roentgenogram, without symptoms, it clinically inconsequential. However, when it is associated with fever, hypoxia, or clinical pneumonia, it becomes clinically relevant. Our composite outcome of postoperative pulmonary complications included all those clinically relevant outcomes. Prospective clinical trials in thoracic surgery are hard to come by. We believe it is important that we conduct and publish them, even when the results are negative. It is equally important that we have healthy scientific discussions about the methods and results of such trials, and for this my colleagues and I would like to thank Ms Chen and Dr Eltorai [1Chen J. Eltorai A.E.M. Incentive spirometry after lung resection: the importance of patients’ adherence (letter).Ann Thorac Surg. 2019; 107: 985Abstract Full Text Full Text PDF Scopus (4) Google Scholar] for starting this process. Incentive Spirometry After Lung Resection: The Importance of Patients’ AdherenceThe Annals of Thoracic SurgeryVol. 107Issue 3PreviewOn reading the article by Malik and colleagues [1] on the effect of adding incentive spirometry (IS) to routine physiotherapy on rates of postoperative pulmonary complications (PPCs) after lung resection, we wish to congratulate the authors and offer some comments. In this trial, 192 patients received routine daily physiotherapy where they were taught exercises, including practicing 10 deep breaths every waking hour. Another 195 patients received an IS device in addition to physiotherapy and were instructed by the physiotherapist to take 10 deep breaths with the IS each waking hour. Full-Text PDF