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The Clinical DATAPAST Function🔗

Info

The final paper on this topic is available here. It was presented to the OpenSAFELY Steering Board and the Joint GP IT Committee in December 2024; the preferred option in section 6 was supported by both groups.

The Clinical DATAPAST (Data Publication, Advice and Support Team) function will act as a distinct but integral part of the publication approval service which was piloted during the pandemic.

Publication approval = Clinical DATAPAST advice + NHS England approval decision

What does the Clinical DATAPAST do?🔗

The Clinical DATAPAST function will provide advisory feedback to users (and the study leads) from clinical advisors1 on any work submitted for publication approval prior to NHS England receiving the work for an approval decision.

Each submitted piece of work will ordinarily receive feedback from two advisors.

Why does the Clinical DATAPAST exist?🔗

The Clinical DATAPAST forms one of several mitigations established by the OpenSAFELY service to address the GP profession’s requirements:

  • to maintain alignment with the project’s approved purpose;
  • to maintain the quality of the publication content by advising project leads regarding how clinical interactions are coded within GP EHR systems;
  • to help ensure conclusions on clinical policies and services are supported by the data.

Who is part of the Clinical DATAPAST?🔗

Prior to full implementation of the Clinical DATAPAST (expected sometime shortly after April 2025), we will roll out an interim process where the regular clinical advisor will be Dr Amir Mehrkar, an NHS GP, Clinical Informatician, and Director of IG and External Relations at OpenSAFELY. He will be supported by other clinicians (such as clinical pharmacists and clinical informaticians), as well as data scientists and epidemiologists with strong experience in GP data.

It is expected that when the Clinical DATAPAST is fully implemented, all advisors will be clinicians or clinical informaticians (or another member of the general practice team appropriate for the study in question); all will have some knowledge of Electronic Health Record data and quantitative research methods, and be independent from the OpenSAFELY service and the Bennett Institute for Applied Data Science (University of Oxford).

The Joint GP IT Committee of the British Medical Association and Royal College of GPs are in support of the interim process, pending full implementation.

What does the NHS England approval decision assess?🔗

The primary assessment of NHS England is to determine that the study leads did in fact do what they said they would do as was written in their initial application. Put simply, was the material submitted in-line with the approved project purpose? If not, NHS England will provide advice to the study leads.

To make their judgement, NHS England will use the actual material submitted, including the lay summary, and the information from the DATAPAST templates. As data controller, NHS England may exercise their judgement on how to constructively act on (both internally and externally) any information that could be deemed contentious, for example, information that could materially affect patient safety. NHS England will promptly communicate with study leads if there are any matters of concern.

How will the interim process work?🔗

A summary🔗

  • There will be a structured DATAPAST template that advisors use to provide advice on your submitted work; academic users may recognise some parallels with the peer review process for journal submission.
  • The template includes sections for users to provide responses.
  • The completed templates, submitted work (with any amendments following users' consideration of the advice), and the lay summary will then be submitted to NHS England for an approval decision.
  • The completed templates, independent of the final NHS England approval decision, will be placed in the public domain (most likely attached to the project on our jobserver, but the exact location is yet to be determined).

The detail🔗

The DATAPAST template has four sections:

  • Compliance with study purpose and policies for researchers
  • Quality
  • Discussion and conclusions
  • Any other comments

The workflow for submission for publication approval🔗

All OpenSAFELY project outputs (e.g results, papers, presentations, etc.) need to be approved before they can be made public (e.g. submitting to a journal or a pre-print server, or uploading to any public facing website). The Clinical Datapast Review forms part of this publication approval process. For full guidance, including step-by-step instructions, can be found on the Policies for Researchers webpage > Acknowledgement and Data Sharing/Publication Policy > Publication of Results > in the Datasets used section.

The timelines🔗

  1. Users can expect to receive the DATAPAST templates from advisors within 2-4 weeks of submitting their work for publication approval (subject to annual leave and other service pressures). For specific review cutoff dates please see our publication of results policy.
  2. After the DATAPAST templates have been reviewed and completed by users (alongside any amendments to work, where appropriate), the work will be submitted to NHS England for an approval decision.
  3. NHS England typically responds within 2 weeks (subject to annual leave and service pressures).

Please refer to the policies for researchers page for full details of the publication review process, which now incorporates the Clinical DATAPAST function.

Please reach out to your co-pilot in the meantime if you have any questions, or post them in the user slack channel.

The OpenSAFELY Leadership Team.

  1. GPs, including clinicians from other relevant professions with the necessary experience and skills to provide project-specific advice ↩