Role of Patient-Reported Outcomes in Clinical Trials in Metastatic Colorectal Cancer: A Scoping Review

To perform a scoping review on the use of Patient-Reported Outcome Measures (PROMs) in randomized trials on systemic therapy in patients with metastatic colorectal cancer (mCRC) between 2010 and 2021. First, a search on clinicaltrials.gov was performed, looking for randomized trials in mCRC. The use...

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Published inCancers Vol. 15; no. 4; p. 1135
Main Authors Maring, Jan Gerard, Eijsink, Job F H, Tichelaar, Friso D, Veluwenkamp-Worawutputtapong, Pawida, Postma, Maarten J, Touw, Daan J, de Groot, Jan Willem B
Format Journal Article
LanguageEnglish
Published Switzerland MDPI AG 10.02.2023
MDPI
Subjects
Cancer
Cancer therapies
Care and treatment
Clinical outcomes
Clinical trials
Colorectal cancer
Colorectal carcinoma
Metastases
Metastasis
Patient outcomes
Patients
Quality of life
Questionnaires
Review
Netherlands
colorectal cancer
PROM
mCRC
review
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Summary:To perform a scoping review on the use of Patient-Reported Outcome Measures (PROMs) in randomized trials on systemic therapy in patients with metastatic colorectal cancer (mCRC) between 2010 and 2021. First, a search on clinicaltrials.gov was performed, looking for randomized trials in mCRC. The use of PROMs was analyzed quantitatively. Subsequently, we assessed the completeness of PROM reporting based on the CONSORT PRO extension in publications related to the selected trials acquired using Embase and PubMed. A total of 46/176 trials were registered on clinicaltrials.gov used PROMs. All these trials used validated PROM instruments. The EORTC QLQ-C30 was most frequently used (37 times), followed by the EQ-5D (21 times) and the EORTC QLQ-CR29 (six times). A total of 56/176 registered trials were published. In 35% ( = 20), the results of the PROMs were available. Overall, 7/20 (35%) trials documented all items of the CONSORT PRO extension and quality of reporting according to the CONSORT PRO extension was higher than in the period 2004-2012. In 3/20 (15%) of the published trials, the results of PROMs were not discussed nor included in the positioning of the new treatment compared to the reference treatment. When PROMs are used, the quality of reporting on patient-reported outcomes is improving, but this must continue in order to optimize the translation of trial results to individual patient values.
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ISSN:2072-6694
2072-6694
DOI:10.3390/cancers15041135