The impact of outpatient vs inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion – the OPTIMUM randomized clinical trial

Abstract

BackgroundThe principal aim of malignant pleural effusion (MPE) management is to improve health related quality of life (HRQoL) and symptoms.MethodsIn this open-label randomised controlled trial, patients with symptomatic MPE were randomly assigned to either IPC insertion with the option of talc pleurodesis or chest drain and talc pleurodesis. The primary endpoint was global health status, measured with the EORTC QLQ-C30 questionnaire at 30 days post-intervention. 142 participants were enrolled from July 2015 to December 2019.ResultsOf participants randomly assigned to IPC (n=70) and chest drain (n=72), primary outcome data were available in 58 and 56 patients, respectively. Global health status improved in both groups at day 30 compared to baseline: IPC (mean difference 13.11 p=0.001) and chest drain (mean difference 10.11 p=0.001). However, there was no significant between-group difference at day 30 (mean inter-group difference in baseline-adjusted global health status of 2.06 ([95% CI −5.86 to 9.99]; p=0.61), day 60 or day 90. No significant differences were identified between groups in breathlessness and chest pain scores. All chest drain arm patients were admitted (median length of stay 4 days); 7 in the IPC arm required intervention-related hospitalization.ConclusionWhile HRQoL significantly improved in both groups, there were no differences in patient reported global health status at 30 days. The outpatient pathway using an IPC was not superior to inpatient treatment with a chest drain.Trial Registration: ISRCTN registration:15503522.