Evidence-to-decision framework for mRNA testing for HPV

Summary of judgements

	JUDGEMENT
DESIRABLE EFFECTS	Trivial	Small	Moderate	Large		Varies	Don’t know
UNDESIRABLE EFFECTS	Large	Moderate	Small	Trivial		Varies	Don’t know
CERTAINTY OF EVIDENCE	Very low	Low	Moderate	High			No included studies
VALUES	Important uncertainty or variability	Possibly important uncertainty or variability	Probably no important uncertainty or variability	No important uncertainty or variability
BALANCE OF EFFECTS	Favours the comparison	Probably favours the comparison	Does not favour either the intervention or the comparison	Probably favours the intervention	Favours the intervention	Varies	Don’t know
RESOURCES REQUIRED	Large costs	Moderate costs	Negligible costs and savings	Moderate savings	Large savings	Varies	Don’t know
CERTAINTY OF EVIDENCE OF REQUIRED RESOURCES	Very low	Low	Moderate	High			No included studies
COST EFFECTIVENESS	Favours the comparison	Probably favours the comparison	Does not favour either the intervention or the comparison	Probably favours the intervention	Favours the intervention	Varies	No included studies
EQUITY	Reduced	Probably reduced	Probably no impact	Probably increased	Increased	Varies	Don’t know
ACCEPTABILITY	No	Probably no	Probably yes	Yes		Varies	Don’t know
FEASIBILITY	No	Probably no	Probably yes	Yes		Varies	Don’t know

Type of recommendation

Strong recommendation against the intervention

○

Conditional recommendation against the intervention

○

Conditional recommendation for either the intervention or the comparison

○

Conditional recommendation for the intervention

○

Strong recommendation for the intervention

○

Conclusions

Recommendation

In the general population of women, HPV DNA is the recommended primary screening test, but HPV mRNA detection may also be used.

When providing HPV mRNA testing, WHO suggests:

providing it with or without triage;
using samples taken by the health-care provider; and
5-year screening intervals.

[Conditional recommendation, low-certainty evidence]

Remarks:

HPV DNA is the recommended screening test. Choosing the alternative option of HPV mRNA testing implies having the capacity to provide follow-up screening at 5-year intervals.

Note: No recommendation was made for using HPV mRNA in women living with HIV because evidence on the outcomes of using HPV mRNA detection applicable to this population was not identified.

Justification

Despite the similar cross-sectional sensitivity and specificity of HPV mRNA testing compared with HPV DNA testing, a conditional recommendation was made for the use of HPV mRNA as a primary screening test because the longitudinal evidence on HPV mRNA test performance is uncertain. Modelling data suggest that there may be similar reductions in cervical cancer cases and deaths when using HPV mRNA testing with or without triage compared with HPV DNA testing with or without triage. In addition, there may be fewer treatments for pre-cancerous lesions when using HPV mRNA testing. However, the evidence from the mathematical model is uncertain, as the predicted reductions in cases and deaths when using HPV mRNA testing overlap with the uncertainty intervals for those with HPV DNA testing, and the model validation was performed against limited longitudinal data. Some longitudinal data with follow-up of more than five years and a model trial validation exercise (based on follow-up at 4–7 years) suggest that the incidence of CIN3+ may be higher in women who were negative for HPV mRNA compared with those who were negative for HPV DNA. There also do not appear to be other reasons related to feasibility or resources in favour of selecting HPV mRNA testing rather than HPV DNA testing.

The evidence available did not include women living with HIV, and data from the general population of women was not applicable to that population. Therefore, no recommendation was made for women living with HIV.

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Bookshelf ID: NBK576605

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WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention: Use of mRNA tests for human papillomavirus (HPV) [Internet]. 2nd edition.

Web AnnexEvidence-to-decision framework for mRNA testing for HPV

Evidence-to-decision table

Summary of judgements

Type of recommendation

Conclusions

Recommendation

Justification

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