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).
The ECO MEDICS AG EXHALYZER® D was chosen as the most suitable MBN2W device due to its ability to accurately and precisely measure in the age range from infants to adults. The CF community has globally recognized that N2 based MBW testing using this device is the preferred method for multi-centre studies. Link to ecomedics - http://www.ecomedics.com
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.
Naïve MBW operators typically attend a 2 day 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.
Link to certification requirements
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.