Obs-TIVA UK

Obs-TIVA UK is run by a main project team who have collaborated with the trainee research networks (TRNs) and individual departments in an effort to maximise participation. The project lead is Dr Yavor Metodiev, Consultant Anaesthetist at University Hospital of Wales, Cardiff. He is supported by Dr Lucy de Lloyd, Dr Rachel Collis, Dr Sarah Bell, Dr Ben Sharif, Dr Helen Iliff and WAAREN (Welsh Anaesthesia Audit Research and Engagement Network).

When will the project take place?

The data collection will take place over an initial period of 12 months from November 2022 to November 2023. However, this may be extended at the discretion of the main project team depending on recruitment during this period. Each site can join at any point during the recruitment period.

When will the results be disseminated?

We are aiming to publish the results by June 2024 (assuming the recruitment period is not extended beyond November 2023).

What is the aim of the project?

Obs-TIVA UK aims to explore the current practices with regards to total intravenous anaesthesia (TIVA) for obstetric surgical interventions in the United Kingdom. The primary aim is to look at incidences of TIVA use in this cohort. The secondary aim is to explore practices with regards to use of TIVA (equipment, drugs, pharmacokinetic models, monitoring), maternal and fetal outcomes.

How do I get involved?

A member of the main project team or your local Trainee Research Network (TRN) may have already made contact with your site, however if you have yet to hear anything, please contact the main project team by email (Yavor.Metodiev@wales.nhs.uk) and we can assist you in registering the project or put you in touch with people on your site, and / or local TRN who are already involved.

What acknowledgement will I receive?

All consultant leads, case submitters, trainee regional leads and Trainee Research Networks will be named as Obs-TIVA UK collaborators on all presentations, publications resulting from the project. All collaborators will receive a certificate of participation in the project.

I am a trainee; can I be the local site lead?

No. For governance reasons local site leads must be a consultant. Trainees can get involved either by submitting a case, or through their local trainee research network.

How many local investigators can be involved per site?

There is no hard and fast rule here. There should be one consultant lead locally. However, any anaesthetist regardless of grade can submit eligible cases as they arise.

Is patient consent required to collect the data?

No. Obs-TIVA UK is registered at each Trust / Health Board as a service evaluation collecting anonymised data – no patient consent is required.

Is Good Clinical Practice (GCP) training required?

No.

Does Obs-TIVA UK require Confidentiality Advisory Group Section 251 Clearance?

Obs-TIVA UK only collects fully anonymised data and therefore does not require CAG Section 251 clearance as per the flowsheet here

Has Obs-TIVA UK undergone Information Governance reviews?

Yes. The need for consent has been waived by the Research Department in Cardiff and Vale UHB as the project is not research and poses no risks to patients or their health-related data. The data sharing agreement has been prepared by the Information Governance team in Cardiff and Vale following their approval.

How do I register Obs-TIVA UK locally?

Obs-TIVA UK should be registered as a service evaluation with your local Clinical Governance department. It does not require Research and Development clearance.

Who can sign the data sharing agreement?

The data sharing agreement should be signed by an Information Governance officer at your hospital. We advise to seek advice from your local Information Governance team.

How is the data uploaded?

All data is submitted to a secure data server based upon the REDCap platform. Links to the “site recruitment” form and “case report form” will be sent to the local lead upon return of the data sharing agreement and confirmation of local registration for participation.

What if there is some data missing on the case record form (CRF)?

Please try and ensure all data is complete. It is expected that in some cases the treating anaesthetist may not fully complete the CRF. In this case we hope local teams can retrospectively complete the CRF from available data. It is for this reason the local ID field is included on the paper CRF. In the very unlikely event you are unable to complete the CRF please obtain as much data as possible and flag this to the local project lead who can in turn notify the main project team.

What is the “local ID” on the paper CRF?

This is located on a tear-off strip on the right-hand side of the CRF. It is optional and we expect sites locally to decide upon the best way to use it in conjunction with their Clinical Governance departments. The expected use is to provide a pseudo anonymised identifier for the particular patient which is then removed when data collection is complete. The local ID also provides a means for the local investigators to retrospectively identify patients to complete any missing data in the CRF. The local ID must be detached from the CRF once all data for the patient has been captured and must not be uploaded to the REDCap data capture server.

Can private hospitals participate?

No. Only NHS hospitals are eligible to participate in Obs-TIVA UK.

What if I have a question that is not answered here?

Please review the other supporting documents on the project, which include the protocol and the “Running Obs TIVA-UK at your site” document. If you do not find an answer to your question there please let us know by email at (Yavor.Metodiev@wales.nhs.uk).

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