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

Parthipan Sivakumar, Deirdre B Fitzgerald, Hugh Ip, Deepak Rao, Alex West, Farinaz Noorzad, Deirdre Wallace, Mohamed Haris, Benjamin Prudon, Gihan Hettiarachchi, Deepak Jayaram, James Goldring, Nick Maskell, Jayne Holme, Neel Sharma, Iyad Ismail, Owais Kadwani, Sanchez Simpson, Catherine A Read, Xiaohui SunAbdel Douiri, Yc Gary Lee, Liju Ahmed

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: The principal aim of malignant pleural effusion (MPE) management is to improve health related quality of life (HRQoL) and symptoms.

METHODS: In 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.

RESULTS: Of 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.

CONCLUSION: While 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.

Original languageEnglish
JournalEuropean Respiratory Journal
DOIs
Publication statusE-pub ahead of print - 23 Nov 2023

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