Evidence generation plan for HTG10877 Technologies for diagnosing endometriosis in primary care
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2 Evidence gaps
This section describes the evidence gaps, why they need to be addressed and their relative importance for future committee decision making.
The committee will not be able to make a positive recommendation without the essential evidence gaps (see section 2.1) being addressed. The company can strengthen the evidence base by also addressing as many other evidence gaps (see section 2.2) as possible. This will help the committee to make a recommendation by ensuring it has a better understanding of the patient or healthcare system benefits of the technology.
2.1 Essential evidence for future committee decision making
Diagnostic accuracy in an NHS primary care setting
There is no data on the diagnostic accuracy of the technologies in NHS primary care. It is important to understand how the technologies perform compared with current NHS practice in primary care. The committee agreed that the different populations and technicalities of operating the tests in primary care compared with secondary care could affect the technologies' diagnostic performance. The committee also highlighted that clearer reporting of failure rates is needed. This could impact diagnostic performance and the need for further testing.
Impact on diagnostic pathway and resource use
More information is needed on how using the technologies would affect resource use during and after implementation to help the committee understand the technologies' long-term resource-use impacts. For example, the additional time needed to carry out a test may result in fewer people being seen in primary care than in standard care. Collecting evidence on this will help the committee understand how using the technologies will affect care in the NHS. Key areas that will help to address this evidence gap are:
the time and associated resources used to perform the tests by reporting practitioners, including additional reviews by specialists or resources, such as an additional room for doing the test
the number of people referred for further testing (including imaging or laparoscopy)
the number of people having medication for endometriosis
time to treatment
time to presumptive diagnosis
long-term resource-use costs, such as number and extent of treatments and number of hospital appointments or emergency department visits
the costs of technology acquisition, implementing (including training), integrating, maintaining and using the technologies
cost savings associated with avoided downstream tests.
Patient outcomes and experience
More evidence on patient-related outcome and experience measures, for example intervention uptake, satisfaction, quality of life, acceptability and preferences, will help the committee assess the technologies' real-world uptake and support future cost-effectiveness modelling.
2.2 Evidence that further supports committee decision making
Clinical effectiveness in different subgroups
The impact of the technologies on clinical effectiveness and resource and service use in different subgroups is unknown. The committee discussed that subgroup analyses in the following subgroups would be useful:
young people
women, trans men and non-binary people who:
are approaching menopause or who have experienced menopause
are from ethnic minority backgrounds
find transvaginal ultrasound unacceptable, or for whom transvaginal ultrasound is not suitable.
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