210 Chapter 6 Appendix 4. Illustrative case of pilot testing Table 1 describes how the initially broad key question brought in the pilot was clarified by the interview process leading to the identification of specific issues to be clarified. These were included as part of the test-management pathway (Figure 1) that were originally not explicitly identified by the user prior to applying this approach. Table 1. Example of an initially ambiguous key question clarified through testmanagement pathway development General topic MRI to replace mammography in breast cancer screening Initially ambiguous non-specific / broad key question Will using MRI instead of mammography to screen for breast cancer lead to a higher survival of women at high risk of developing breast cancer? Key concerns identified through the step-by-step approach of pathway development Patients, Setting, Timing (P) Naïve, high-risk women (i.e. with a family history of breast cancer) below the age of 50 years, identified through general practitioners and then referred to secondary care where they will enter the pathway Index test(s) (I) MRI is the replacement test being considered, although not all hospitals will have this facility Comparison or Existing test/strategy (C) Mammography is the existing test/strategy and the available treatment options identified were combinations of radiotherapy/chemotherapy/ surgery/immunotherapy depending on tumour type and stage with varying prognosis Outcomes of interest (O) Increased (breast-cancer specific / disease-free) survival among high-risk women through early detection Reduced anxiety of disease and hence improve quality of life through reassurance Impact on clinical management decisions would involve re-testing after a year for true negatives and false negatives; follow up in six months for false positives Linking outcomes to test accuracy True positives: will go through biopsy and receive treatment depending on risk category True negatives: will be re-tested a year later False positives: unnecessary biopsy and anxiety; will be monitored in approximately 6 months’ time False negatives: wrongly reassured and may only be diagnosed a year later
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