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

JWG Derksen, GR Vink, MA Elferink, JML Roodhart, HM Verkooijen, WMU van Grevenstein, PD Siersema, AM May, M Koopman, GL Beets, EJT Belt, M Berbée, FH Beverdam, R Blankenburgh, PPLO Coene, H Cruijsen, JW Dekker, JM van Dodewaard-de Jong, FLG Erdkamp, JWH GrootAW Haringhuizen, HH Helgason, MP Hendriks, IHJT de Hingh, R Hoekstra, J.N.M. IJzermans, J Jansen, FWH Kloppenberg, AU van Lent, M Los, MR Meijerink, L J Mekenkamp, P Nieboer, KCMJ Peeters, NA Peters, MB Polée, JFM Pruijt, CJ Punt, PQ van Ufford-Mannesse, RC Rietbroek, AHW Schiphorst, AS van der Velden, RWM Schrauwen, MPS Sie, L Simkens, DW Sommeijer, DJA Sonneveld, LEA Spierings, HB Stockmann, K Talsma, F Terheggen, AJ ten Tije, MLR Tjin-a-Ton, LBJ Valkenburg-van Iersel, RP Veenstra, AMT van der Velden, M Vermaas, WJ Vles, JFJ Vogelaar, T van Voorthuizen, AI Vos, JA Wegdam, JHW Wilt, DDE Zimmerman

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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.

Original languageEnglish
Article number3923
JournalScientific Reports
Volume11
Issue number1
DOIs
Publication statusPublished - 16 Feb 2021

Bibliographical note

Funding Information:
The Prospective Dutch Colorectal Cancer (PLCRC) cohort is an initiative of the Dutch Colorectal Cancer Group (DCCG). PLCRC is supported by the Dutch Cancer Society; Stand Up to Cancer; ZonMw; Health Holland; Maag Lever Darm Stichting; Lilly (unrestricted grant); Merck (unrestricted grant); Bristol-Myers Squibb (unrestricted grant); Bayer (unrestricted grant); and Servier (unrestricted grant). The current work is supported by the Province of Utrecht, the Netherlands.

Publisher Copyright:
© 2021, The Author(s).

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