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

Jan Gerard Maring; Job F H Eijsink; Friso D Tichelaar; Pawida Veluwenkamp-Worawutputtapong; Maarten J Postma; Daan J Touw; Jan Willem B de Groot

doi:10.3390/cancers15041135

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

Jan Gerard Maring^*, Job F H Eijsink, Friso D Tichelaar, Pawida Veluwenkamp-Worawutputtapong, Maarten J Postma, Daan J Touw, Jan Willem B de Groot

^*Corresponding author for this work

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

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Abstract

PURPOSE: 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.

METHODS: 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.

RESULTS: 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% ( n = 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.

CONCLUSION: 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.

Original language	English
Article number	1135
Number of pages	14
Journal	Cancers
Volume	15
Issue number	4
DOIs	https://doi.org/10.3390/cancers15041135
Publication status	Published - 10-Feb-2023

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@article{e934ac4a2cdf4cf5bcec6ffa3f98a71b,

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

abstract = "PURPOSE: 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.METHODS: 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.RESULTS: 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% ( n = 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. CONCLUSION: 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.",

author = "Maring, {Jan Gerard} and Eijsink, {Job F H} and Tichelaar, {Friso D} and Pawida Veluwenkamp-Worawutputtapong and Postma, {Maarten J} and Touw, {Daan J} and {de Groot}, {Jan Willem B}",

year = "2023",

month = feb,

day = "10",

doi = "10.3390/cancers15041135",

language = "English",

volume = "15",

journal = "Cancers",

issn = "2072-6694",

publisher = "MDPI AG",

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TY - JOUR

T1 - Role of Patient-Reported Outcomes in Clinical Trials in Metastatic Colorectal Cancer

T2 - A Scoping Review

AU - Maring, Jan Gerard

AU - Eijsink, Job F H

AU - Tichelaar, Friso D

AU - Veluwenkamp-Worawutputtapong, Pawida

AU - Postma, Maarten J

AU - Touw, Daan J

AU - de Groot, Jan Willem B

PY - 2023/2/10

Y1 - 2023/2/10

N2 - PURPOSE: 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.METHODS: 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.RESULTS: 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% ( n = 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. CONCLUSION: 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.

AB - PURPOSE: 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.METHODS: 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.RESULTS: 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% ( n = 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. CONCLUSION: 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.

U2 - 10.3390/cancers15041135

DO - 10.3390/cancers15041135

M3 - Review article

C2 - 36831478

SN - 2072-6694

VL - 15

JO - Cancers

JF - Cancers

IS - 4

M1 - 1135

ER -

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

Abstract

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