Acutelines

Hospital-based data-biobank to facilitate acute and emergency research. Facility
Research in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, lack of singular ownership of the domain of acute care, and absence of integrated data along the acute patient journey, from early in the course of the acute disease up to long after hospital discharge. To overcome these challenges, we have established a de novo data-biobank for acute and emergency medicine: Acutelines.

We initiated to improve recognition and treatment of acute diseases and obtain insight into the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to the development of acute personalised treatment and improves the prediction of patient outcomes after an acute admission.

Our main aims are 

  • To facilitate research in acute and emergency medicine by providing the framework for novel clinical studies.
  • To facilitate translational research to develop acute personalized medicine, amongst others by issuing data, images, and biomaterials. 
  • To monitor and improve quality of care in the fields of acute and emergency medicine.

We prospectively include adult patients (age ≥ 18 years) visiting the emergency department, who are referred to internal medicine, nephrology, geriatric medicine, oncology, hematology, lung medicine, rheumatology, gastrointestinal / liver medicine, or emergency medicine (non-trauma). The emergency nurse and a trained research assistant screen all patients for inclusion in Acutelines and collection of data and biomaterials.

Data and biomaterial collection during acute, hectic moments

Samples will be collected prior to the start of treatment, at the earliest moment of presentation. A deferred consent procedure (by proxy), is in place to allow collecting data and biomaterials prior to obtaining written consent. Clinical data, imaging data and biomaterials (i.e. blood, urine, feces, hair) are collected. The digital infrastructure used ensures automated capturing of all bed-side monitoring data (i.e. 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.

  • In order to allow biomaterial collection when applicable upon first contact, primary screening of patients for eligibility upon arrival in the emergency department is performed by the emergency nurse together with a trained research assistant. After identification and informing potentially eligible participants, the nurse will collect blood specimens for Acutelines during venipuncture for regular care. Subsequently, the research assistant informs participants and their relatives, obtains consent (by proxy), and collects and processes data and biomaterials in the emergency department. Additionally, information about pre-hospital care is obtained from the (helicopter) emergency medical service (HEMS).

  • Data are collected from all included participants during the first 72-hours of their hospitalization, while follow-up data is collected at 3-months, 1-year, 2-years and 5 years after their ED visit. We invited participants to complete questionnaires to obtain information about perceived symptoms, quality of life, functioning and outcome goal prioritisation. Additionally, we obtain data about medication use, co-morbidity and mortality from the electronic health records in out hospital, as well as from external sources (i.e. general practitioner, pharmacy, health care registration, central statistics office and municipal registration).

  • Collected data and biomaterials can be made available for other researchers upon request by submitting the completed research protocol. Each request for further use of data and/or biomaterials is reviewed by Acutelines and the central review committee (CRc) of the UMCG.

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Background information

  • The Acutelines infrastructure allows screening of all patients admitted to the emergency department, where we have the facilities to rapidly process biomaterials. We have an IT infrastructure to obtain (high-frequency) cardiorespiratory signals and transfer data from the electronic health records to the research database.

    The Acutelines infrastructure allows assessing the effect of novel techniques (such as algorithms, devices) on diagnosis, treatment, monitoring, outcome and logistics in the emergency department, as well as rapid implementation of these techniques in clinical practice. Acutelines is embedded in a large academic hospital, which ensures structured data storage and management, with continued adherence to high legal and ethical standards.

    Connections (via trusted third parties) with central registries allow obtaining pre-hospital and long-term follow-up data from external sources (i.e. general practitioner, pharmacy, health care registration, central statistics office, and municipal registration). Acutelines adheres to the following laws and guidelines:

    • Good Clinical Practice (GCP)
    • Good Laboratory Practice (GLP)
    • General Data Protection Act (2016/679)
    • ISO 9001­:2008

    Acutelines is registered under trial registration number NCT04615065 at ClinicalTrials.gov.

  • To be eligible for inclusion, according to the latest version of the Acutelines protocol participants have to meet at least one of the following criteria:

    • Patients with the highest- and second-highest urgency triage categories (red or orange) of the Emergency Severity Index (ESI)
    • Patients with the third-highest category urgency triage category (yellow) of the ESI when arriving by (Helicopter) Emergency Medical Service
    • Patients with several specific conditions regardless of their triage category are included: early sepsis, shock, syncope, anaphylaxis, acute renal failure, electrolyte disturbances intoxications, COPD and asthma exacerbations, (suspicion of) deep venous thrombosis or pulmonary embolism, gastrointestinal bleeding, and patients who are bleeding (any source) whilst using vitamin-K antagonists or DOAC.

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  • Clinical data

    • Admission reason, including signs and symptoms
    • Physical examination and vital parameters (e.g., body temperature, blood pressure, heart rate, breathing frequency)
    • General characteristics (e.g., judgment of treating physician)
    • Additional results (e.g., x-rays, scans, ultrasound, laboratory results)
    • (Non)pharmacologic treatment information

    Questionnaires

    • Demographic data (e.g., age, sex, marital status, education, living situation, ethnicity)
    • Family history
    • Lifestyle (e.g., smoking, alcohol consumption, illicit drug use)
    • Global functioning and experienced health (e.g., EQ-5D-5L, Katz-ADL-15, Piper Fatigue Scale-12, PHQ-15)
    • Mood (e.g., PHQ-2, PHQ-9, GDS-15)
    • Shared decision making (e.g., PSQ-18, OPT)
    • Nutrition and activity (e.g., SNAQ, MUST, SQUASH)
    • Frailty, delirium and cognitive function (e.g., VMS, 4-AT, 6-CIT)

    Biomaterials

    • Serum
    • Citrate plasma
    • EDTA-plasma + buffy coat (DNA)
    • Heparin-plasma
    • Whole blood (PaxGene, for RNA)
    • Urine
    • Faeces
    • Tress of hair
  • Motivated, smart researchers are essential to Acutelines’ success. We are continuously looking for smart, motivated people to support the team. Students from either Universities of Applied Sciences and Universities with a (bio)medical background (such as medicine, technical medicine, pharmacy, nursing, biology, life science, biomedical sciences), scientific or technical background (such as epidemiology, artificial intelligence, [bio]informatics) are highly encouraged to contact us for (short) research projects or to join our team as a research assistant for a longer period.

    From time to time we also recruit students with other backgrounds, such as communication or management studies (i.e. facility and process management). Next to facilitating research in the field of acute and emergency medicine, Acutelines organizes an education program about acute and emergency medicine for the team members.

Contact

Hjalmar Bouma Internist acute medicine, pharmacologist, immunologist

Acutelines UMCG
Internal postcode TA10
PO Box 30.001
9700 RB Groningen
The Netherlands