The National Institute for Health and Care Excellence (NICE) is producing early value guidance on using KardiaMobile 6L. The diagnostics advisory committee has considered the evidence and the views of clinical and patient experts. This topic is the first pilot using the new early value assessment approach. The aim of early value guidance is to provide quicker conditional recommendations from NICE on promising medical technologies while uncertainty in their evidence base is being addressed.
You can now comment on the early value guidance consultation document.
It summarises the evidence and views that have been considered and sets out the evidence generation recommendations made by the committee. NICE invites comments from registered stakeholders, healthcare professionals and the public.
How to comment
You should read both the consultation document and the accompanying evidence (see the committee papers) before making any comments.
We have a new way of making comments on this consultation. You must make your comments directly onto the online version of the consultation document. When you go into the document you will find instructions on how to use the new commenting software. You can also review and edit your comments before you submit them.
You can download a PDF version of the consultation document, but you can only make comments on the online version.
Consultation documents
- Consultation document (Diagnostics consultation document (Online commenting) Early Value Guidance)
- Consultation document (Diagnostics consultation document (PDF) Early Value Guidance)
- Committee papers (Overview, Early Value Assessment Report, Cost and Resources Report, stakeholder comments on the Early Value Assessment Report and responses, stakeholder comments on the Cost and Resources Report and responses)
Closing date for comments: 25 August 2022
About the consultation
The advisory committee is interested in receiving comments on the following:
- Has all of the relevant evidence been considered?
- Are the summaries of clinical effectiveness, costs and resource use reasonable interpretations of the evidence?
- Are the recommendations sound, and a suitable basis for early value guidance to the NHS?
NICE would also welcome comments on the style and presentation of this guidance and how suitable it is for informing practitioners, commissioners and managers in the NHS.
Equality issues
NICE is committed to promoting equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. Please let us know if you think that the recommendations may need changing to meet these aims. In particular, please tell us if the recommendations:
- could have a different effect on people protected by the equality legislation than on the wider population, for example by making it more difficult in practice for a specific group to access the technology
- could have any adverse effect on people with a particular disability or disabilities.
Please provide any relevant information or data you have about such effects and how they could be avoided or reduced.
Note that this document is not NICE's final guidance on KardiaMobile 6L for measuring cardiac QT interval in people having antipsychotic medication. The conditional recommendations in section 1 and the accompanying points on evidence generation in section 4 may change after consultation.
After consultation, NICE will consider the comments received. The final recommendations will be the basis for NICE’s early value guidance on using the technology with evidence generation.
If you have any queries, please contact diagnostics@nice.org.uk
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