The LCI Core Facility
In 2012 the ECFS-CTN discussed the current concerns of technical and project management issues regarding LCI measurement. There was a clear need for a European central competence centre to provide training and centralised quality control in order to implement MBW into multicentre studies. Our group at the Royal Brompton / Imperial College London took on the role of establishing the CTN Lung Clearance Index Central Core Facility in July 2014. We are a designated research group with extensive experience in MBW testing and interpretation of results. The Core Facility sets standards and assesses traces submitted by CTN member sites, qualifying those meeting a predefined set of quality criteria so providing a pool of suitable sites available to sponsors. Furthermore the Core provides a centralised over-reading system, thus improving consistency of scoring. To facilitate global trials, SOPs have been agreed in close alignment with corresponding investigators for N. America (Ratjen, Toronto).
Who we are
Jane Davies
Jane is Professor in Paediatric Respirology & Experimental Medicine at the National Heart and Lung Institute and an Honorary Consultant in Paediatric Respiratory Medicine at the Royal Brompton & Harefield NHS Foundation Trust. In 2014, on behalf of the ECFS-CTN, Jane formed the Lung Clearance Index facility in response to the need for standardization of multiple breath washout for multicentre clinical trial use.Clare Saunders
After graduating with a BSc Physiology in 2000 Clare trained in adult lung function testing before working within several London hospitals gaining experience in paediatric CF clinical and research respiratory measurements, including the multiple breath washout technique. In 2006 Clare joined Imperial College and the Royal Brompton & Harefield NHS Foundation Trust as the lead respiratory physiologist working on clinical trials for the UK CF Gene therapy consortium. She now leads the European Lung Clearance Index facility providing training, certification and central over-reading in the multiple breath washout technique using the Exhalyzer D system.Training
Interpretation of MBW test results is highly dependent on the quality of the data obtained by the operator. To ensure the correct interpretation of MBW measurements, standardized training, certification, quality control and over-reading protocols have been developed to systematically evaluate clinical trial data where LCI is an outcome measure. The Central MBW Training and Over-reading Centre’s team at Sick Kids, Toronto, lead this development with the European and Australian competence centers.
To enquire about upcoming training opportunities – please contact us directly at gstt.lcicore@nhs.net
Training process
Naïve MBW operators typically go through our hybrid training approach, which includes attending a 1-day F2F training session on the operation of the MBWN2 system according to the SOP. They are expected to practice the skills obtained, at their site, before collecting the required data to submit for certification. This step verifies quality of measurements and addresses any difficulties prior to study initiation. In some circumstances where an operator is previously certified, yet has either been out of practice for some time or demonstrated problems collecting acceptable data, a 1-day refresher training course would likely be more appropriate. The operators attending the training sessions should be those individuals who will carry out measurements on study participants. The training is designed to facilitate correct operation of the device and real-time decision-making about test quality. Training and certification is neither sponsor, nor study, specific. Once certified the operator can perform MBW measurements for other clinical trials. It is up to the individual sites to obtain the required research ethics approval allowing them to obtain these qualifying test occasions. All training tests will be submitted as de-identified files for review.
Certification requirements & submission documents:
Over reading
The LCI Core Facility provide a centralised over reading centre to sponsors choosing to include MBW in their clinical trials. We are responsible for over-reading all MBW tests throughout the trial to identify acceptable data that will be used in generating the final study output. Quality control feedback and support is provided to sites regarding their data acquisition for the duration of the study.Supporting clinical trials utilising MBW
The LCI Core Facility works with sponsors to develop study specific documentation to ensure:
a) sites are informed on the appropriate MBW equipment, procedure and settings required for the trial
b) operators are certified and, in a position, to collect acceptable data
c) sites are supported throughout the trials to maintain the data quality
d) data is transferred to the sponsor at agreed time points