Process evaluation of the PREPARE trial Preoperative inspiratory muscle training to prevent postoperative pneumonia in patients undergoing esophageal resection

Abstract

Aim: Esophageal cancer is a common disease with increasing incidence. The most common treatment for esophageal cancer is surgical resection. The mortality rate of pneumonia after surgical resection is approximately 20%, compared to 3% in patients without pneumonia. The PREPARE trial (preoperative inspiratory muscle training to prevent postoperative pneumonia in patients undergoing esophageal resection) was designed to investigate the effect of inspiratory muscle training (IMT) on the incidence of postoperative pneumonia and respiratory function after esophageal surgery. A process evaluation was performed alongside this trial to investigate the experiences of patients and the involved physiotherapists participating in the PREPARE trial. The aim of this study was to evaluate the protocol of the PREPARE trial, its execution any bottlenecks that may influence the outcomes of the trial. Methods: A generic qualitative approach was used. Six semi-structured interviews were conducted with patients who participated the PREPARE trial and four semi-structured interviews were performed with involved physiotherapists. Results: Overall, the experiences of the patients and physiotherapists were positive, particularly on the organization and information of the PREPARE trial. However, contamination bias occurred (n=1), no measurements were performed after surgery (n=1) and there were problems with using the device (n=1). The Physiotherapists had problems with performing the endurance measurement and found the time investment high. Conclusion: The PREPARE trial was positively evaluated by patients and physiotherapists. The PREPARE trial was performed according to protocol on most aspects, a few deviations were reported. Clinical Relevance: This is the first process evaluation of a trial which investigate the effect of IMT. This process evaluation gives more insight in the execution of the PREPARE trial. In combination with outcome of the trial, this study may lead to an improvement of the study protocol when bottlenecks will be tackled.