Project Name: European Clinical Research Alliance on Infectious Diseases
ECRAID-Base - description & overall objectives
ECRAID-Base (European Clinical Research Alliance for Infectious Diseases) continues and extends large-scale European research consortia including: PREPARE, COMBACTE, RECOVER, and ECRAID-Plan. As a European clinical research network, ECRAID-Base will generate rigorous evidence to improve the diagnosis, prevention and treatment of well-characterized infectious diseases and facilitate the detection of and response to emerging infectious diseases (EIDs).
ECRAID-Base includes 6 perpetual studies, 5 perpetual observational studies (POSs), which are ongoing cohorts based in intensive care units, emergency rooms, and primary care settings that address infections relevant for antimicrobial resistance (AMR), including ventilator-associated pneumonia (VAP), complicated urinary tract infections (cUTI), and EID, with a focus on acute respiratory infections and unexplained febrile illnesses.
The sixth ongoing study in ECRAID-Base is the Randomized Embedded Multifactorial Adaptive Platform for patients with severe Community-acquired Pneumonia in ICU (REMAP- CAP; https://www.remapcap.eu/). REMAP-CAP was launched in 2014 and is managed by Monash University in Australia. Similar to the 5 POSs, REMAP-CAP is designed to rapidly pivot to address EIDs and includes embedded COVID-19 studies.
The 6 perpetual studies serve as a ‘warm-base’ network which has and will continue to facilitate the rapid design and launch of randomised controlled trials (RCTs) that respond to pressing public health priorities. For example, within two months of the declaration of COVID-19 as a public health emergency of international concern, the REMAP-CAP began collecting COVID-19 related data and expanded to include hospital and ICU patients to better capture the spectrum of COVID-19 related symptoms and outcomes.
The main objectives of the 6 ongoing multinational studies are to:
- directly enrol patients with infectious diseases to generate evidence to support the testing and development of new diagnostic, preventive and/or therapeutic strategies and therapies;
- conduct a broad range of rigorous clinical studies efficiently and rapidly;
- rapidly respond to public health threats both through improved surveillance and through enabling the rapid launch of RCTs that leverage existing teams, data flows, and agreements.
POS-VAP - description & objectives
In this Horizon Booster application, we are specifically seeking funds to support the interoperability of VAP and AMR-related data from the POS-VAP study (one of the 6 studies within the ECRAID-Base Consortium). POS-VAP is a hospital-based cohort focused on identifying and addressing VAP. VAP, often caused by multi-drug resistant bacteria, is a frequent complication of mechanically-ventilated ICU patients. Distinguishing bacterial colonisation of the respiratory tract from infection of the lung tissue is difficult with currently available diagnostics resulting in the unnecessary use of broad-spectrum antibiotics in many patients, which in turn leads to AMR. The primary objectives of the POS VAP study are to (1) provide an infrastructure capable of rapidly implementing novel observational studies and RCTs to improve VAP prevention, diagnosis, and treatment; (2) conduct descriptive analyses related to patient characteristics, complications, outcome and risk factors; (3) to provide participant-level VAP data to E-CDC and national surveillance authorities to improve the detection and control of AMR and VAP in European ICUs.
Reason for applying to HSbooster.eu services
Our ambition is to enable a federated analysis of participant-level data for AMR-related surveillance and informed clinical care. We would like to ensure that the POS-VAP eCRF is specified in both CDASH (work we have completed) and HL7 FHIR (work that we would like to complete with support from someone with expertise in HL7 FHIR who has at least a basic understanding of CDASH). We see building cross-ontology interoperability within study eCRFs that address public health priorities, like AMR, as a way to enable the goal of real-time surveillance where interoperability coupled with federated approaches to data reuse, where the data are not directly accessed, enables secure and ethical use of data to rapidly inform clinical and public health policy.
We are requesting funding support to transform the POS-VAP eCRF into HL7 FHIR. The POS-VAP eCRF was mainly built using CDASH as informing clinical trial design and facilitating clinical trials that can rapidly respond to emerging public health priorities are central to ECRAID's mission. Within ECRAID, one of our objectives is to ensure that ECRAID-Base POS are FAIR by design. This means that eCRFs and related study forms, including the informed consent, data management plan, and protocol are designed using relevant standard semantic ontologies to capture and communicate information. While the first step to enabling interoperability is to use a recognised standard for capturing or exchanging health data, we see the second step towards enabling cross-study interoperability as creating cross-walks between standards. In this application, we would like to secure guidance to create a crosswalk between CDASH, which is widely used in diagnostic and drug development-related studies and required for regulatory submission in many countries, and HL7 FHIR, which is more often used in the observational health data space. We would specifically like to work closely with an expert in HL7 FHIR to conduct the mapping between CDASH and HL7 FHIR so that related studies that focus on VAP and AMR could reuse the eCRF whether they prefer to use CDASH or HL7 FHIR. Because HL7 FHIR is widely used in Real-world data (RWD), the transformation of the ECRAID Base POS-VAP eCRF into HL7 FHIR will facilitate connections with hospital- and health system-based data reuse initiatives, including the European Health Data Space and country level health data spaces in Germany, Netherlands, Spain, Greece, etc.
Creating cross-standard cross-walks must be informed by a team that includes the clinical expertise needed to understand whether critical information is retained and the ontology expertise needed to understand whether the information from one standard is appropriately documented in another standard. Our understanding is that the Horizon Booster program is currently looking for experts and may not have someone who could speak to our specific goals here. In that case, we are also interested in being paired with an expert in metadata ontologies, preferably in the health space, to assist us in the creation of machine actionable metadata.
ECRAID - Base has limited experience with HL7 FHIR and no funding to develop CDASH to FHIR- related cross walks in the AMR or EID space.
Main Standardisation Interests
In addition to the 5 ongoing hospital bases cohort networks and platform adaptive RCT network, ECRAID Base has work packages (WPs) that focus on support for laboratory diagnosis and sample management, data and statistical methods development, training, and improving outbreak response. Our WP includes the data curation, analysis, management, and sharing activities in ECRAID - Base. The main objectives are to -maximise the impact and benefits of the POS studies within ECRAID for clinical practice, surveillance, the design and conduct of RCTs, and diagnostic, prognostic, and treatment-related devices and medicines while upholding the rights of research participants under GDPR and related country-level regulations.
assess, establish, support and optimise the data harmonisation, standardization and sharing processes for all the studies and networks within ECRAID-Base with a focus on FAIR by design and ethical data reuse
CDISC (CDASH/SDTM) - Central Library
We have used the principles of FAIR by design to create an ECRAID-Base - wide library of eCRFs that are compliant with some of the most widely used standardised data capture ontologies in the health care research space, including CDISC (CDASH/SDTM), CDISC CT, NCBI Taxonomy ID (microorganisms), EUCAST/CLSI guidelines (antimicrobial susceptibility), ATC/DDD codes (antimicrobial drugs), MedDRA and ICD-10. This work ensures that ECRAID-Base data are interoperable across disease focii within ECRAID and with related datasets from studies outside of ECRAID. This work represents an important contribution to the fields of VAP, cUTI, and AMR through the creation of FAIR eCRFs that can be extended and reused within those disease communities.
Open Call Topic(s): Health