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
N1 - Publisher Copyright:
© 2024 The Authors
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 - http://www.scopus.com/inward/record.url?scp=85190152554&partnerID=8YFLogxK
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 -