The impact of outpatient              versus              inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised 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 Sun; Abdel Douiri; Y.C. Gary Lee; Liju Ahmed

doi:10.1183/13993003.01215-2022

The impact of outpatient versus inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised 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, Y.C. Gary Lee, Liju Ahmed

Research output: Contribution to journal › Article › peer-review

10 Citations (Scopus)

149 Downloads (Pure)

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 indwelling pleural catheter (IPC) insertion with the option of talc pleurodesis or chest drain and talc pleurodesis. The primary end-point was global health status, measured with the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) at 30 days post-intervention. 142 participants were enrolled from July 2015 to December 2019.

Results: Of participants randomly assigned to the IPC (n=70) and chest drain (n=72) groups, primary outcome data were available in 58 and 56 patients, respectively. Global health status improved in both groups at day 30 compared with 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 intergroup difference in baseline-adjusted global health status 2.06, 95% CI −5.86–9.99; 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); seven patients in the IPC arm required intervention-related hospitalisation.

Conclusions: 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.

Original language	English
Article number	2201215
Journal	European Respiratory Journal
Volume	63
Issue number	2
Early online date	23 Nov 2023
DOIs	https://doi.org/10.1183/13993003.01215-2022
Publication status	Published - 1 Feb 2024

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1183/13993003.01215-2022

The impact of outpatient_SIVAKUMAR_Accepted21October2023_GREEN AAM (CC BY)Accepted author manuscript, 524 KBLicence: CC BY

Cite this

Sivakumar, P., Fitzgerald, D. B., Ip, H., Rao, D., West, A., Noorzad, F., Wallace, D., Haris, M., Prudon, B., Hettiarachchi, G., Jayaram, D., Goldring, J., Maskell, N., Holme, J., Sharma, N., Ismail, I., Kadwani, O., Simpson, S., Read, C. A., ... Ahmed, L. (2024). The impact of outpatient versus inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised clinical trial. European Respiratory Journal, 63(2), Article 2201215. https://doi.org/10.1183/13993003.01215-2022

@article{9b33d99ec95e45de8460de28d421e931,

title = "The impact of outpatient versus inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised clinical trial",

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 indwelling pleural catheter (IPC) insertion with the option of talc pleurodesis or chest drain and talc pleurodesis. The primary end-point was global health status, measured with the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) at 30 days post-intervention. 142 participants were enrolled from July 2015 to December 2019.Results: Of participants randomly assigned to the IPC (n=70) and chest drain (n=72) groups, primary outcome data were available in 58 and 56 patients, respectively. Global health status improved in both groups at day 30 compared with 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 intergroup difference in baseline-adjusted global health status 2.06, 95% CI −5.86–9.99; 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); seven patients in the IPC arm required intervention-related hospitalisation.Conclusions: 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.",

author = "Parthipan Sivakumar and Fitzgerald, {Deirdre B.} and Hugh Ip and Deepak Rao and Alex West and Farinaz Noorzad and Deirdre Wallace and Mohamed Haris and Benjamin Prudon and Gihan Hettiarachchi and Deepak Jayaram and James Goldring and Nick Maskell and Jayne Holme and Neel Sharma and Iyad Ismail and Owais Kadwani and Sanchez Simpson and Read, {Catherine A.} and Xiaohui Sun and Abdel Douiri and Lee, {Y.C. Gary} and Liju Ahmed",

note = "Funding Information: Conflict of interest: P. Sivakumar reports grants from Rocket Medical, outside the submitted work. D.B. Fitzgerald reports grants from the European Respiratory Society, outside the submitted work. N. Maskell reports grants and personal fees from Beckton Dickinson and Company, outside the submitted work. Y.C.G. Lee reports non-financial support and grants from Rocket Medical, outside the submitted work. L. Ahmed reports grants from GE, outside the submitted work. No other disclosures were reported. Funding Information: Support statement: This trial was funded by an unrestricted research grant from Becton Dickinson, which also supplied PleurX catheters and drainage bottles for use in the study. The trial was sponsored by Guy{\textquoteright}s and St Thomas{\textquoteright} NHS Foundation Trust who provided trial oversight for both national and international recruitment centres. Neither the funder nor the sponsor had a role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication. Funding information for this article has been deposited with the Crossref Funder Registry. Publisher Copyright: Copyright {\textcopyright} The authors 2024.",

year = "2024",

month = feb,

day = "1",

doi = "10.1183/13993003.01215-2022",

language = "English",

volume = "63",

journal = "European Respiratory Journal",

issn = "0903-1936",

publisher = "European Respiratory Society",

number = "2",

}

Sivakumar, P, Fitzgerald, DB, Ip, H, Rao, D, West, A, Noorzad, F, Wallace, D, Haris, M, Prudon, B, Hettiarachchi, G, Jayaram, D, Goldring, J, Maskell, N, Holme, J, Sharma, N, Ismail, I, Kadwani, O, Simpson, S, Read, CA , Sun, X , Douiri, A, Lee, YCG & Ahmed, L 2024, 'The impact of outpatient versus inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised clinical trial', European Respiratory Journal, vol. 63, no. 2, 2201215. https://doi.org/10.1183/13993003.01215-2022

The impact of outpatient versus inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised clinical trial. / Sivakumar, Parthipan; Fitzgerald, Deirdre B.; Ip, Hugh et al.
In: European Respiratory Journal, Vol. 63, No. 2, 2201215, 01.02.2024.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The impact of outpatient versus inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised clinical trial

AU - Sivakumar, Parthipan

AU - Fitzgerald, Deirdre B.

AU - Ip, Hugh

AU - Rao, Deepak

AU - West, Alex

AU - Noorzad, Farinaz

AU - Wallace, Deirdre

AU - Haris, Mohamed

AU - Prudon, Benjamin

AU - Hettiarachchi, Gihan

AU - Jayaram, Deepak

AU - Goldring, James

AU - Maskell, Nick

AU - Holme, Jayne

AU - Sharma, Neel

AU - Ismail, Iyad

AU - Kadwani, Owais

AU - Simpson, Sanchez

AU - Read, Catherine A.

AU - Sun, Xiaohui

AU - Douiri, Abdel

AU - Lee, Y.C. Gary

AU - Ahmed, Liju

N1 - Funding Information: Conflict of interest: P. Sivakumar reports grants from Rocket Medical, outside the submitted work. D.B. Fitzgerald reports grants from the European Respiratory Society, outside the submitted work. N. Maskell reports grants and personal fees from Beckton Dickinson and Company, outside the submitted work. Y.C.G. Lee reports non-financial support and grants from Rocket Medical, outside the submitted work. L. Ahmed reports grants from GE, outside the submitted work. No other disclosures were reported. Funding Information: Support statement: This trial was funded by an unrestricted research grant from Becton Dickinson, which also supplied PleurX catheters and drainage bottles for use in the study. The trial was sponsored by Guy’s and St Thomas’ NHS Foundation Trust who provided trial oversight for both national and international recruitment centres. Neither the funder nor the sponsor had a role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication. Funding information for this article has been deposited with the Crossref Funder Registry. Publisher Copyright: Copyright © The authors 2024.

PY - 2024/2/1

Y1 - 2024/2/1

N2 - 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 indwelling pleural catheter (IPC) insertion with the option of talc pleurodesis or chest drain and talc pleurodesis. The primary end-point was global health status, measured with the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) at 30 days post-intervention. 142 participants were enrolled from July 2015 to December 2019.Results: Of participants randomly assigned to the IPC (n=70) and chest drain (n=72) groups, primary outcome data were available in 58 and 56 patients, respectively. Global health status improved in both groups at day 30 compared with 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 intergroup difference in baseline-adjusted global health status 2.06, 95% CI −5.86–9.99; 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); seven patients in the IPC arm required intervention-related hospitalisation.Conclusions: 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.

AB - 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 indwelling pleural catheter (IPC) insertion with the option of talc pleurodesis or chest drain and talc pleurodesis. The primary end-point was global health status, measured with the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) at 30 days post-intervention. 142 participants were enrolled from July 2015 to December 2019.Results: Of participants randomly assigned to the IPC (n=70) and chest drain (n=72) groups, primary outcome data were available in 58 and 56 patients, respectively. Global health status improved in both groups at day 30 compared with 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 intergroup difference in baseline-adjusted global health status 2.06, 95% CI −5.86–9.99; 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); seven patients in the IPC arm required intervention-related hospitalisation.Conclusions: 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.

UR - http://www.scopus.com/inward/record.url?scp=85184673566&partnerID=8YFLogxK

U2 - 10.1183/13993003.01215-2022

DO - 10.1183/13993003.01215-2022

M3 - Article

SN - 0903-1936

VL - 63

JO - European Respiratory Journal

JF - European Respiratory Journal

IS - 2

M1 - 2201215

ER -

Sivakumar P, Fitzgerald DB, Ip H, Rao D, West A, Noorzad F et al. The impact of outpatient versus inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised clinical trial. European Respiratory Journal. 2024 Feb 1;63(2):2201215. Epub 2023 Nov 23. doi: 10.1183/13993003.01215-2022

The impact of outpatient versus inpatient management on health-related quality of life outcomes for patients with malignant pleural effusion: the OPTIMUM randomised clinical trial

Abstract

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this