Patient-reported outcomes in randomized clinical trials of systemic therapy for advanced soft tissue sarcomas in adults: A systematic review.
Crit Rev Oncol Hematol
; 197: 104345, 2024 May.
Article
in En
| MEDLINE
| ID: mdl-38582227
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Sarcoma
/
Randomized Controlled Trials as Topic
/
Patient Reported Outcome Measures
Limits:
Adult
/
Humans
Language:
En
Journal:
Crit Rev Oncol Hematol
Journal subject:
HEMATOLOGIA
/
NEOPLASIAS
Year:
2024
Document type:
Article