Project Update May 2017

1)     STUDY RESEARCHERS

Nikil Patel and Katie Peterson have both started work with their research groups and St George’s and Cambridge respectively.

2)      ETHICS/GOVERNANCE

The amendment submitted by Katie to the Chelsea REC regarding the changes to the Information Sheets and Informed Consent forms have now been approved. Consent forms and information sheets have been updated and can be accessed via Dropbox. Consent forms now clearly state that video recordings of test performance (in which they will be personally identifiable) may be used for educational purposes. Participants now have the opportunity to refuse consent for this specific action.

The project has received local R&D approval at the Cambridge site but final sign off at SGUL is still awaited.

This study has now been successfully added to the Clinical Research Network South London Portfolio.

3)      PARTICIPANT RECRUITMENT AND TESTING

Copies of the BDAE have been delivered to SGUL and Cambridge. We will decide what subtests are going to be essential to demonstrate convergent validity with the MLSE. This will be added to the agenda of the next project meeting on Tuesday 18th July 2017.

Tabindah has now successfully handed over the project to Nikil who has continued to administer the pre-norming set to volunteers. We have data on the full set of items from 24 controls so far. This will pick up when the SGUL research office shows the internal green light on displaying recruitment posters. We are waiting to hear back from the research office.

We should aim for patient testing to start in the second half of July, after populating the test sections based on the pre-norming data. This will be slightly later than originally envisaged, but there hasn’t been too much slippage even given the slow and staggered start to the project. We can project to compensate for this towards the end of 2017.

4)      DATABASE

Nikil and Peter discussed the REDCap proposal with SGUL’s Information Governance consultant and the SGUL Solicitor, and there is general agreement that, subject to a data sharing agreement being signed off by all collaborating centres, non-identifiable test data from patients and controls can be stored and shared using this web based solution.

SGUL’s data protection officer (Claire Morrissey) has drafted a data sharing agreement which has been sent for review by the Cambridge and Manchester groups and their respective Information Governance offices. SGUL are currently waiting on the IT department at SGUL to grant us with credentials for REDCap login to begin setting up the REDCap database.

SGUL will draft the REDCap database outline which will be presented at the July meeting.

5)     PROJECT IMPACTS

The project website has been updated with additions to the Home page, Updates page, Contacts page, FAQs page. Please visit the website when you can and feedback/suggestions are welcome. This project update will have been archived in the Updates page.

Katie now has access to admin details and can add any updates that the Cambridge group wish to make.

If Matt and/or Stefano think it would be useful to have someone with admin rights in Manchester and/or Pavia, please could they let Nikil and Peter know.

A paper on the control data from the Italian version of the pilot materials has been accepted for publication in Neurological Sciences. Thanks and congratulations to Eleonora for seeing this through to completion. The paper or a link to it (depending on open access policy) will be posted on the website when production is complete. The paper can now be accessed via Dropbox.

St George’s University’s Clinical Research Facility hosted an International Clinical Trials day on Friday 19th May. This was an open invitation to the members of the public interested in research. The event promoted research from various disciplines, naming a few- paediatric, vascular, and neurosciences research. The neurosciences research team presented current research projects within the department including the MLSE project. Neurosciences was awarded the prize for most interactive and impactful research voted by the members of the public. The neurosciences team will feature on the Clinical Research Network website in the coming month.

6)      DATE OF NEXT PROJECT MEETING

This is set for Tuesday 18th July, from 14:30 to 17:30 at SGUL.  We have received definite confirmation of attendance from all other than Matt. Matt- please let us know if you are able to join us for the meeting.  An agenda for the next meeting will be circulated at the beginning of July.

A table has been reserved at the exceptional Macellaio in Exmouth Market from 19:00 for a collaborators’ dinner. Thanks to all those who have so far confirmed that they will be coming.

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