3 Approach to evidence generation
The proposed approach to addressing the evidence gaps for the Genedrive MT-RNR1 ID Kit is real-world data collection within the evidence generation period. How this approach will address the evidence gaps is considered, and any strengths and weaknesses highlighted.
3.1 Ongoing post-market performance follow up
The technology developer is doing the RNR-01 usability study. This is collecting information on the total number of Genedrive MT-RNR1 tests, the number of positive results (followed up with a confirmatory laboratory test) and the test failure rate. It is also collecting general feedback from the users.
This data will provide additional information about using the Genedrive MT-RNR1 ID Kit in neonatal intensive care, by staff experienced in doing the test. Confirmatory laboratory testing of positive results will help to address the uncertainty around the Genedrive System's diagnostic accuracy (positive predictive value). But it would not allow estimation of other aspects of diagnostic accuracy (sensitivity, specificity, and negative predictive value). The data would also not address the other evidence gaps, including time to antibiotic treatment in non-specialist centres, information on antibiotic prescribing decisions, or the ethnicity of babies having the test.
3.2 Data collection
Centres using the Genedrive MT-RNR1 ID Kit, particularly non-specialist centres outside of neonatal intensive care, could collect data on newborns needing antibiotics for whom aminoglycoside treatment is being considered.
This should include:
-
demographics, including age, sex and ethnicity
-
type of maternity unit and location
-
time from diagnosing suspected sepsis to administering antibiotics
-
test result (positive or negative or failed, and whether first or second result)
-
person doing the test (for example, staff nurse)
-
type of antibiotic given (name and class)
-
laboratory confirmation of a positive Genedrive MT-RNR1 test result (whether the confirmation result is positive or negative).
An audit of time to antibiotic treatment before implementation starts (for example, for 2 weeks) is suggested. This could be followed by a short period of implementation, and a period of data collection while the Genedrive test is being used (for example, for 8 weeks).
Collecting this data would provide information on time to antibiotic treatment in settings other than neonatal intensive care, and address how using the Genedrive MT-RNR1 ID Kit affects antibiotic prescribing decisions. It would also provide more information on failure rate and diagnostic accuracy (positive predictive value) of the test.
Data collection should follow a predefined protocol, and quality assurance processes should be put in place to ensure the integrity and consistency of data collection. See NICE's real-world evidence framework, which provides guidance on the planning, conduct, and reporting of real-world evidence studies.