Cohort profile of Acutelines: a large data/biobank of acute and emergency medicine

Ewoud Ter Avest, Barbara C van Munster, Raymond J van Wijk, Sanne Tent, Sanne Ter Horst, Ting Ting Hu, Lisanne E van Heijst, Felien S van der Veer, Fleur E van Beuningen, Jan Cornelis Ter Maaten, Hjalmar R Bouma, Ewoud Ter Avest, Barbara C van Munster, Raymond J van Wijk, Sanne Tent, Sanne Ter Horst, Ting Ting Hu, Lisanne E van Heijst, Felien S van der Veer, Fleur E van Beuningen, Jan Cornelis Ter Maaten, Hjalmar R Bouma

Abstract

Purpose: Research in acute care faces many challenges, including enrolment challenges, legal limitations in data sharing, limited funding and lack of singular ownership of the domain of acute care. To overcome these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data, image and biobank named 'Acutelines'.

Participants: Clinical data, imaging data and biomaterials (ie, blood, urine, faeces, hair) are collected from patients presenting to the emergency department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy) is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure used ensures automated capturing of all bed-side monitoring data (ie, vital parameters, electrophysiological waveforms) and securely importing data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration and pharmacy. Data are collected from all included participants during the first 72 hours of their hospitalisation, while follow-up data are collected at 3 months, 1 year, 2 years and 5 years after their ED visit.

Findings to date: Enrolment of the first participant occurred on 1 September 2020. During the first month, 653 participants were screened for eligibility, of which 180 were approached as potential participants. In total, 151 (84%) provided consent for participation of which 89 participants fulfilled criteria for collection of biomaterials.

Future plans: The main aim of Acutelines is to facilitate research in acute medicine by providing the framework for novel studies and issuing data, images and biomaterials for future research. The protocol will be extended by connecting with central registries to obtain long-term follow-up data, for which we already request permission from the participant.

Trial registration number: NCT04615065.

Keywords: accident & emergency medicine; general medicine (see internal medicine); internal medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Schematic overview of the Acutelines biobank. By collecting data from prehospital up to long after hospital discharge, Acutelines follows the complete acute patient journey. Specially trained research assistants screen potential participants in the emergency department (ED) (24/7). Waveform data and vital parameters from bed-side monitors are captured automatically, and biomaterials (ie, blood, urine, faeces) will be collected while awaiting deferred consent (by proxy). ED facilities allow rapid processing and storage of biomaterials (−80°C). Wearable devices are used to continue capturing waveforms and vital parameters during the first 72 hours of hospital admission. Connections with the electronic health record and external databases (eg, GP, pharmacy, health insurance companies) allow to collect relevant clinical data when applicable for specific research questions, such as medication use and comorbidity up to 5 years after presentation. Digital survey-based patient-reported outcomes will be collected on fixed intervals and survival will be monitored indefinitely using the municipal registration. GP, general practitioner.
Figure 2
Figure 2
Inclusion criteria of patients for Acutelines in the initiation phase. Data (demographic and medical data, waveforms) will be collected from all patients, but surveys and biomaterials will only be collected from patients with the highest and second highest urgency triage categories (red or orange) of the Emergency Severity Index or patients with a suspicion of sepsis or shock. Blood tube: biomaterials, pen/paper: survey, database: health data (ie, from EHR and central registries), ECG: waveform data with vital parameters. EHR, electronic health record; GI, gastrointestina; COPD, Chronic Obstructive Pulmonary Disease

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