214 Chapter 6 Outcome(s) of interest to avoid or achieve Define the impact of the index test on downstream (patient) outcomes Define the impact of the index test on clinical management decisions What are we trying to avoid, achieve or simplify in patients? Guideline development groups will likely need an introduction on how to define patient outcomes, and its link to medical testing. There may be different outcomes for different settings. Trigger questions: How may the introduction of the index test help to avoid, simplify or improve these (patient) outcome(s)? What is the potential impact of the index test on clinical management decisions e.g. decisions involving referral for further investigation or treatment options etc.? Linking outcomes to the testing What actions follow after the different test results? How do these actions impact the four test accuracy categories (TP, TN,FP, FN) and inconclusive test results? If possible, one could provide weights to different downstream outcomes Trigger questions: For true positives (TP) and false positives (FP): Will patients with a positive test be: referred to a specialist, referred for subsequent testing, treated for the condition? What should ideally be done in those with the target condition? Is there effective treatment available? What will be possible outcomes for patients who do not have the target condition and test positive? For false negatives (FN) and true negative (TN): What will happen to those patients who test negative? Is it assumed that these patients are ‘healthy’ or will they probably have another disease than the target condition? Will the patients be re-tested in due time? How likely is it that this condition will be missed, or will there be a delayed diagnosis in the false negatives? What is the prognosis of patients with the target condition if treatment is being withheld? For inconclusive test results: What will happen to these patients, will they be retested and within what duration and the number of times
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