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. 2021 Feb 16;11(1):3923.
doi: 10.1038/s41598-020-79890-y.

The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care

Jeroen W G Derksen  1   2 , Geraldine R Vink  1   3 , Marloes A G Elferink  3 , Jeanine M L Roodhart  1 , Helena M Verkooijen  4 , Wilhelmina M U van Grevenstein  5 , Peter D Siersema  6   7 , Anne M May  2 , Miriam Koopman  8 ; PLCRC Study Group
Collaborators, Affiliations

The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care

Jeroen W G Derksen et al. Sci Rep. .

Abstract

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.

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Conflict of interest statement

MK reports institutional financial interests with Amgen, Bayer, BMS, Merck-Serono, Nordic Pharma, Roche, Servier, Sirtex, and Sanofi-Aventis. MK reports the following non-financial interests: an advisory role for ZON-MW, membership of the scientific board of the Dutch Cancer Society (KWF), chairmanship of the Dutch Colorectal Cancer Group (DCCG), principal investigator (PI) of the Prospective Dutch Colorectal Cancer (PLCRC) cohort. GRV reports institutional financial interests with Servier, Merck, Bayer, Sirtex, BMS, and Lilly. JMLR reports institutional financial interests with Servier, Merck, and Bayer. PDS reports institutional financial interests with The eNose Company, Norgine, and Motus GI. JWGD, MAGE, HMV, WMUG, and AMM report no competing interests.

Figures

Figure 1
Figure 1
Flow diagram of the selection of individuals for the current analyses. aInsufficient data in patient’s EHRs for the NCR to collect a complete TNM stage. bMissing due to time-lag in NCR clinical data collection. This number is higher than presented in Table 1, as for some cases sufficient staging information was available to classify into TNM stage.
Figure 2
Figure 2
PLCRC recruiting hospitals (academic, non-academic, and top clinical hospitals) over time. Note: In The Netherlands there is a total of 75 hospitals, of which 8 academic hospitals and 26 top-clinical hospitals.
Figure 3
Figure 3
Baseline informed consent percentages per item. The use of clinical NCR data is 100% since this item is mandatory for participation. NCR Netherlands Cancer Registry, PROs  patient-reported outcomes, TwiCs Trials within Cohorts.
Figure 4
Figure 4
Completion rates of questionnaires until three years after enrollment. Overall completion rates are presented in the bars, and electronic and paper-based percentages at the dashed lines. Time-points (T) are months since enrollment.
See this image and copyright information in PMC

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