Every day, vast amounts of valuable clinical data is generated in medical centers. To make optimal use of these routine data, Starting in 2013, the UMC Utrecht started has established an infrastructure which integrates research into routine clinical care. The essence of this infrastructure, is to give every patient the opportunity to contribute to, participate in research and be part of a learning health care system. This way, clinicians and researchers can learn from every patient, with the aim to continuously improve our understanding of diseases, and improve patient outcomes (in particular (disease-free) survival and quality of life). This ALLURE (reAL worLd data UtREcht) infrastructure consists of two major activities:
1) Systematically inviting every patient to participate in clinical research
2) Optimally embedding research projects into causes, diagnosis, prognosis and therapy of various diseases, in the infrastructure.
The patient plays a central role in ALLURE. All patients will be systematically invited to contribute to and participate in clinical research, through an (e-)visit the ‘innovation clinic’, or during hospitalization/hospital visits. Research personnel will inform patients about the importance of patient participation in clinical research, and about privacy protection policies. Patients are asked to provide informed consent for:
• Use of their routine clinical data for translational and clinical research, deep learning activities, product development and linkage to national and regional health databases.
• Storage and use of biomaterials (e.g. tissues, liquid biopsies) and medical images.
• Repeated patient reported outcomes questionnaires (PROs).
In addition, patients are asked to give ‘broad informed consent’ to be invited for future studies, including randomization according to the Trials within Cohorts s (TwiCs) design to participate in intervention research. After randomization an additional informed consent is asked of patients in the intervention arm, before any study treatment is started. Patients can decide for which part they consent.
By means of newsletters, surveys and meetings, patients and patient organizations are actively involved in research prioritization, reviewing research requests, discussing new findings, and providing advise for implementation. On an individual level, patients and physicians have the option to receive an overview of their patient (self) reported outcomes, relative to those of other patients, and the general Dutch population.
ALLURE aims for standardized entry of routine clinical data in electronic health records (EHRs) and automatic extraction of (un)structured data. In addition, ALLURE works with organizations, e.g. National Cancer Registry, Julius General Practitioners Network, Foundation for Pharmaceutical Statistics, to obtain high quality baseline and follow-up information. Data management follows the FAIR (findable, accessible, inter-operable and reusable) principles.
ALLURE currently consists of different disease cohorts, that have been developed at different departments (e.g. cancer, infection and immunity, cardiovascular diseases and cancer). Even though the principle of ‘Learning from every patient’ applies to all cohorts, (slightly) different recruitment approaches have been applied. This process will be standardized and harmonized in future At this moment over 30.000 UMC Utrecht patients have been enrolled and a wide range of research areas is covered (biomarkers, etiology therapeutics imaging artificial intelligence and study designs (cohort studies, case-control studies, TwiCs), health technology assessment) . The concept has proven to be feasible in regional (UMBRELLA-breast cancer, Utrecht Cardiovascular Cohort-cardiovascular disease), national (PLCRC-colorectal cancer) and international settings (MOMENTUM-patients treated with MRI-guided radiotherapy, MEN-1-endocrine tumors).