Dataset Information

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

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.

SUBMITTER: Derksen JWG

PROVIDER: S-EPMC7887218 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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

Derksen Jeroen W G JWG Vink Geraldine R GR Elferink Marloes A G MAG Roodhart Jeanine M L JML Verkooijen Helena M HM van Grevenstein Wilhelmina M U WMU Siersema Peter D PD May Anne M AM Koopman Miriam M

Scientific reports 20210216 1

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 characteristi ...[more]

PMID: 33594104

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Project description:PurposeUsing real-world data (RWD)-based trial simulation approach, we aim to simulate colorectal cancer (CRC) trials and examine both effectiveness and safety end points in different simulation scenarios.MethodsWe identified five phase III trials comparing new treatment regimens with an US Food and Drug Administration-approved first-line treatment in patients with metastatic CRC (ie, fluorouracil, leucovorin, and irinotecan) as the standard-of-care (SOC) control arm. Using Electronic Health Record-derived data from the OneFlorida network, we defined the study populations and outcome measures using the protocols from the original trials. Our design scenarios were (1) simulation of the SOC fluorouracil, leucovorin, and irinotecan arm and (2) comparative effectiveness research (CER) simulation of the control and experimental arms. For each scenario, we adjusted for random assignment, sampling, and dropout. We used overall survival (OS) and severe adverse events (SAEs) to measure effectiveness and safety.ResultsWe conducted CER simulations for two trials, and SOC simulations for three trials. The effect sizes of our simulated trials were stable across all simulation runs. Compared with the original trials, we observed longer OS and higher mean number of SAEs in both CER and SOC simulation. In the two CER simulations, hazard ratios associated with death from simulations were similar to that reported in the original trials. Consistent with the original trials, we found higher risk ratios of SAEs in the experiment arm, suggesting potentially higher toxicities from the new treatment regimen. We also observed similar SAE rates across all simulations compared with the original trials.ConclusionIn this study, we simulated five CRC trials, and tested two simulation scenarios with several different configurations demonstrated that our simulations can robustly generate effectiveness and safety outcomes comparable with the original trials using real-world data.

Project description:This study assessed the lifetime cost-effectiveness of a fracture liaison service (FLS) compared to no-FLS in the Netherlands from a societal perspective and suggested that FLS was cost-effective in patients with a recent fracture aged 50 years and older. The implementation of FLS could lead to lifetime health-economic benefits.IntroductionThe objective of this study was to investigate the lifetime cost-effectiveness of a fracture liaison service (FLS) compared to no-FLS in the Netherlands from a societal perspective and using real-world data.MethodsAnnual fracture incidence, treatment scenarios as well as treatment initiation in the years 2017-2019 were collected from a large secondary care hospital in the Netherlands. An individual-level, state transition model was designed to simulate lifetime costs and quality-adjusted life years (QALYs). Treatment pathways were differentiated by gender, presence of osteoporosis and/or prevalent vertebral fracture, and treatment status. Results were presented as incremental cost-effectiveness ratios (ICER). Both one-way and probabilistic sensitivity analyses were conducted.ResultsFor patients with a recent fracture aged 50 years and older, the presence of an FLS was associated with a lifetime €45 higher cost and 0.11 additional QALY gained leading to an ICER of €409 per QALY gained, indicating FLS was cost-effective compared to no-FLS at the Dutch threshold of €20,000/QALY. The FLS remained cost-effectiveness across different age categories. Our findings were robust in all one-way sensitivity analyses, the higher the treatment initiation rate in FLS, the greater the cost-effective of FLS. Probabilistic sensitivity analyses revealed that FLS was cost-effective in 90% of the simulations at the threshold of €20,000/QALY, with women 92% versus men 84% by gender.ConclusionThis study provides the first health-economic analysis of FLS in the Netherlands, suggesting the implementation of FLS could lead to lifetime health-economic benefits.

Dataset Information

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

Publications

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

Similar Datasets

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