Step-by-step guide 211 6 Population: Naive high risk women below 50 years of age High risk defined as women with a family history of BrCa and/or detected with BRCA gene Some women may choose for preventive operation & will not be included in this screening Setting: Hospital (not all hospitals have MRI) Through GP Index test: MRI vs Existing test: Mammography Outcomes of interest: reduce anxiety/fear of cancer improve survival Lesion on mammography/MRI No lesion on mammography/MRI Further investigation with biopsy (= gold standard) FP: will undergo unnecessary biopsy. There may be an inbetween monitoring step e.g. after 6 months FN: re-testing a year later BrCa No BrCa Therapeutic treatment Prognosis varies: death, recurrence, recovery. Depends on risk category & treatment options re-testing in a year Figure 1. Illustrative example of a test-management pathway developed from user testing: In women with a high risk of developing breast cancer, will using MRI instead of mammography to screen for breast cancer lead to a higher survival of these women In this example, MRI (the index test) is more sensitive than mammography (the comparator), but it is unclear whether it also leads to a better survival in this patient group. Randomized controlled studies exploring the differences between MRI and mammography on people-important outcomes such as mortality are lacking. The testmanagement pathway will generally be the same for both tests. Any difference in survival between the two groups (MRI versus mammography) will therefore be mainly driven by differences in test performance (such as sensitivity and specificity) in results between the two tests. However, a more accurate test does not necessarily lead to a
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