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    Is the evidence generation period appropriate to enable data collection?

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    Is the recommended reference standard appropriate?

Evidence generation plan for HTG10877 Technologies for diagnosing endometriosis in primary care

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5 Minimum evidence standards

During the evidence generation period, new technologies may become available. This section summarises the minimum evidence requirements that a new technology would need to meet to be considered in the NICE evaluation after the evidence generation period.

The committee noted that there is some evidence showing that the technologies have good diagnostic accuracy (sensitivity and specificity above 90%). But this is uncertain primarily because of the lack of data in NHS primary-care settings. It heard that the technologies may improve quality of life by reducing time to diagnosis and treatment, but evidence for this was also limited.

For new technologies, the committee indicated that it may, in future, be able to recommend technologies in this topic area that have UK-based evidence for:

  • non-inferiority of the technology compared with standard care in terms of diagnostic accuracy

  • user engagement with the technology, including satisfaction, acceptability and preferences

  • cost savings resulting from resource use associated with the technologies.

Companies can strengthen the evidence base by having evidence for diagnostic accuracy and uptake rates in different subpopulations.