| Autor: |
Derksen JWG; Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands.; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands., Vink GR; Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands.; Department of Research, Netherlands Comprehensive Cancer Organisation (IKNL), PO Box 19079, 3501 DB, Utrecht, The Netherlands., Elferink MAG; Department of Research, Netherlands Comprehensive Cancer Organisation (IKNL), PO Box 19079, 3501 DB, Utrecht, The Netherlands., Roodhart JML; Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands., Verkooijen HM; Imaging Division, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands., van Grevenstein WMU; Department of Surgical Oncology, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands., Siersema PD; Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands.; Department of Gastroenterology and Hepatology, Radboud UMC, Radboud University, PO Box 9101, 6500 HB, Nijmegen, The Netherlands., May AM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands., Koopman M; Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, PO Box 85500, 3508 GA, Utrecht, The Netherlands. m.koopman-6@umcutrecht.nl. |
| Abstrakt: |
Real-world data (RWD) sources are important to advance clinical oncology research and evaluate treatments in daily practice. Since 2013, the Prospective Dutch Colorectal Cancer (PLCRC) cohort, linked to the Netherlands Cancer Registry, serves as an infrastructure for scientific research collecting additional patient-reported outcomes (PRO) and biospecimens. Here we report on cohort developments and investigate to what extent PLCRC reflects the "real-world". Clinical and demographic characteristics of PLCRC participants were compared with the general Dutch CRC population (n = 74,692, Dutch-ref). To study representativeness, standardized differences between PLCRC and Dutch-ref were calculated, and logistic regression models were evaluated on their ability to distinguish cohort participants from the Dutch-ref (AU-ROC 0.5 = preferred, implying participation independent of patient characteristics). Stratified analyses by stage and time-period (2013-2016 and 2017-Aug 2019) were performed to study the evolution towards RWD. In August 2019, 5744 patients were enrolled. Enrollment increased steeply, from 129 participants (1 hospital) in 2013 to 2136 (50 of 75 Dutch hospitals) in 2018. Low AU-ROC (0.65, 95% CI: 0.64-0.65) indicates limited ability to distinguish cohort participants from the Dutch-ref. Characteristics that remained imbalanced in the period 2017-Aug'19 compared with the Dutch-ref were age (65.0 years in PLCRC, 69.3 in the Dutch-ref) and tumor stage (40% stage-III in PLCRC, 30% in the Dutch-ref). PLCRC approaches to represent the Dutch CRC population and will ultimately meet the current demand for high-quality RWD. Efforts are ongoing to improve multidisciplinary recruitment which will further enhance PLCRC's representativeness and its contribution to a learning healthcare system. |
