Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review

Evelyne Roets; Winette van der Graaf; Bauke H G van Riet; Rick L Haas; Eugenie Younger; Francesco Sparano; Roger Wilson; Stevie van der Mierden; Neeltje Steeghs; Fabio Efficace; Olga Husson

doi:10.1016/j.critrevonc.2024.104345

Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review

Evelyne Roets
, Winette van der Graaf
, Bauke H G van Riet
, Rick L Haas
, Eugenie Younger
, Francesco Sparano
, Roger Wilson
, Stevie van der Mierden
, Neeltje Steeghs
, Fabio Efficace
, Olga Husson^*

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

Abstract

BACKGROUND: This systematic review evaluates reporting of patient-reported outcomes (PROs) within randomized clinical trials (RCTs) for advanced soft tissue sarcoma (STS) patients.

METHODS: A systematic literature search from January 2000 - August 2022 was conducted for phase II/III RCTs evaluating systemic treatments in adult patients with advanced STS. Quality of PRO reporting was assessed using the CONSORT PRO extension.

RESULTS: Out of 7294 abstracts, 59 articles were included; comprising 43 RCTs. Only 15 RCTs (35%) included PROs, none as primary endpoints. Only 10 of these RCTs reported PROs, either in the primary (6/10) or secondary publication (1/10) or in both (3/10), with a median time interval of 23 months. The median CONSORT PRO adherence score was 5.5/14, with higher scores in publications focusing exclusively on PROs.

CONCLUSION: These results highlight the need for improved and more consistent PRO reporting to inform patient care in the setting of advanced STS.

Original language	English
Article number	104345
Journal	Critical Reviews in Oncology/Hematology
Volume	197
DOIs	https://doi.org/10.1016/j.critrevonc.2024.104345
Publication status	Published - May 2024
Externally published	Yes

Keywords

Health-related quality of Life (HRQoL)
Patient-reported outcomes (PROs)
Randomized clinical trial (RCT)
Soft tissue sarcoma (STS)
Systemic therapy

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Roets, E., van der Graaf, W., van Riet, B. H. G., Haas, R. L., Younger, E., Sparano, F., Wilson, R., van der Mierden, S., Steeghs, N., Efficace, F., & Husson, O. (2024). Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review. Critical Reviews in Oncology/Hematology, 197, Article 104345. https://doi.org/10.1016/j.critrevonc.2024.104345

@article{3531fa776d504071b53e17b7d1edf246,

title = "Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review",

abstract = "BACKGROUND: This systematic review evaluates reporting of patient-reported outcomes (PROs) within randomized clinical trials (RCTs) for advanced soft tissue sarcoma (STS) patients.METHODS: A systematic literature search from January 2000 - August 2022 was conducted for phase II/III RCTs evaluating systemic treatments in adult patients with advanced STS. Quality of PRO reporting was assessed using the CONSORT PRO extension.RESULTS: Out of 7294 abstracts, 59 articles were included; comprising 43 RCTs. Only 15 RCTs (35\%) included PROs, none as primary endpoints. Only 10 of these RCTs reported PROs, either in the primary (6/10) or secondary publication (1/10) or in both (3/10), with a median time interval of 23 months. The median CONSORT PRO adherence score was 5.5/14, with higher scores in publications focusing exclusively on PROs.CONCLUSION: These results highlight the need for improved and more consistent PRO reporting to inform patient care in the setting of advanced STS.",

keywords = "Health-related quality of Life (HRQoL), Patient-reported outcomes (PROs), Randomized clinical trial (RCT), Soft tissue sarcoma (STS), Systemic therapy",

author = "Evelyne Roets and \{van der Graaf\}, Winette and \{van Riet\}, \{Bauke H G\} and Haas, \{Rick L\} and Eugenie Younger and Francesco Sparano and Roger Wilson and \{van der Mierden\}, Stevie and Neeltje Steeghs and Fabio Efficace and Olga Husson",

note = "Publisher Copyright: {\textcopyright} 2024 The Authors",

year = "2024",

month = may,

doi = "10.1016/j.critrevonc.2024.104345",

language = "English",

volume = "197",

journal = "Critical Reviews in Oncology/Hematology",

issn = "1040-8428",

publisher = "Elsevier Ireland Ltd",

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Roets, E, van der Graaf, W, van Riet, BHG, Haas, RL, Younger, E, Sparano, F, Wilson, R, van der Mierden, S, Steeghs, N, Efficace, F & Husson, O 2024, 'Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review', Critical Reviews in Oncology/Hematology, vol. 197, 104345. https://doi.org/10.1016/j.critrevonc.2024.104345

TY - JOUR

T1 - Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults

T2 - A systematic review

AU - Roets, Evelyne

AU - van der Graaf, Winette

AU - van Riet, Bauke H G

AU - Haas, Rick L

AU - Younger, Eugenie

AU - Sparano, Francesco

AU - Wilson, Roger

AU - van der Mierden, Stevie

AU - Steeghs, Neeltje

AU - Efficace, Fabio

AU - Husson, Olga

PY - 2024/5

Y1 - 2024/5

N2 - BACKGROUND: This systematic review evaluates reporting of patient-reported outcomes (PROs) within randomized clinical trials (RCTs) for advanced soft tissue sarcoma (STS) patients.METHODS: A systematic literature search from January 2000 - August 2022 was conducted for phase II/III RCTs evaluating systemic treatments in adult patients with advanced STS. Quality of PRO reporting was assessed using the CONSORT PRO extension.RESULTS: Out of 7294 abstracts, 59 articles were included; comprising 43 RCTs. Only 15 RCTs (35%) included PROs, none as primary endpoints. Only 10 of these RCTs reported PROs, either in the primary (6/10) or secondary publication (1/10) or in both (3/10), with a median time interval of 23 months. The median CONSORT PRO adherence score was 5.5/14, with higher scores in publications focusing exclusively on PROs.CONCLUSION: These results highlight the need for improved and more consistent PRO reporting to inform patient care in the setting of advanced STS.

AB - BACKGROUND: This systematic review evaluates reporting of patient-reported outcomes (PROs) within randomized clinical trials (RCTs) for advanced soft tissue sarcoma (STS) patients.METHODS: A systematic literature search from January 2000 - August 2022 was conducted for phase II/III RCTs evaluating systemic treatments in adult patients with advanced STS. Quality of PRO reporting was assessed using the CONSORT PRO extension.RESULTS: Out of 7294 abstracts, 59 articles were included; comprising 43 RCTs. Only 15 RCTs (35%) included PROs, none as primary endpoints. Only 10 of these RCTs reported PROs, either in the primary (6/10) or secondary publication (1/10) or in both (3/10), with a median time interval of 23 months. The median CONSORT PRO adherence score was 5.5/14, with higher scores in publications focusing exclusively on PROs.CONCLUSION: These results highlight the need for improved and more consistent PRO reporting to inform patient care in the setting of advanced STS.

KW - Health-related quality of Life (HRQoL)

KW - Patient-reported outcomes (PROs)

KW - Randomized clinical trial (RCT)

KW - Soft tissue sarcoma (STS)

KW - Systemic therapy

UR - https://www.scopus.com/pages/publications/85190152554

U2 - 10.1016/j.critrevonc.2024.104345

DO - 10.1016/j.critrevonc.2024.104345

M3 - Review article

C2 - 38582227

SN - 1040-8428

VL - 197

JO - Critical Reviews in Oncology/Hematology

JF - Critical Reviews in Oncology/Hematology

M1 - 104345

ER -

Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review

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Keywords

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