Module 19 2021

Intended Purpose and Clinical Performance

• The clinical condition: how detailed? • Fairly clear but do not try to be comprehensive.You would have to provide evidence for all the listed clinical conditions • An example for aldosterone:

• Too vague, not really associated with a condition: “Aldosterone measurements are useful to identify excessive or deficient levels of aldosterone.”

• Too detailed: “Aldosterone measurements are useful to aid in the diagnosis of adrenal hyperplasia, adrenal adenoma, adrenal carcinoma, massive ascites, ventricular failure, cor pulmonale, proximal renal tubular acidosis, fibromuscular dysplasia, excessive licorice intake, etc., etc.” • Better: “Aldosterone measurements are useful to aid in the diagnosis of conditions associated with primary or secondary hyperaldosteronism (e.g., congenital adrenal hyperplasia) or with primary or secondary hypoaldosteronism (e.g., primary adrenal insufficiency).”

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