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By | April 17, 2021

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Physical therapists routinely perform diagnostic tests on their patients. For diagnostic test results to be most useful, we contend that validity estimates from studies of the diagnostic test in question should be used to guide clinical decisions. The purpose of this perspective is to describe a conceptual model proposed by other authors1,2 for the application of validity indexes for diagnostic (or prognostic) tests to clinical practice. We use a clinical illustration to demonstrate how measures, which we refer to as “validity indexes” (ie, sensitivity, specificity, positive and negative predictive values, likelihood ratios), can be interpreted for individual patients. The illustration combines data from 2 studies on the use (validity) of the Berg Balance Test (BBT) for predicting risk of falls among elderly people aged 65 to 94 years.3,4 The illustration is meant only to demonstrate how validity indexes can be useful for practice and not necessarily to assist clinicians in the examination of patients suspected of having balance disorders.Studies that can be used to determine whether meaningful clinical inferences can be made based on diagnostic tests are classified as “criterion-related validity studies.”5 Criterion-related validity studies take 1 of 2 forms. Researchers can compare a clinical measure with a “gold standard” measure (ideally, a valid diagnostic test or a definitive measure of whether the condition of interest is truly present) obtained at about the same time as the measure being studied. In our illustration, the patient’s report of falling is considered the gold standard measure. In other cases, a gold standard measure may be a diagnosis made at the time of surgery or via an invasive diagnostic procedure. Studies in which some form of gold standard is obtained at about the same time as the diagnostic test being studied are commonly called “concurrent criterion-related validity studies.”5 Researchers can also compare a measure’s prediction of a future event with what actually happens to a patient in the future. These studies are commonly termed “predictive criterion-related validity studies.”5

Studies designed to estimate the risk of a future adverse event are often used by clinicians to make judgments about prognoses. For example, investigating whether the BBT can be used to predict whether a person will fall in the future is an illustration of a predictive criterion-related validity study. The gold standard for this type of study would be the subjects’ report of falls for a period of time following administration of the BBT.The Berg Balance Primary aldosteronism (PA) is characterized by an autonomous aldosterone secretion leading to sodium retention, arterial hypertension and hypokalemia (1). PA is the most common endocrine cause of secondary hypertension, with a prevalence between 5 and 13% in patients with arterial hypertension (1, 2, 3). The disease is associated with an increased cardiovascular risk and renal complications (2, 4, 5). Whereas unilateral oversecretion of aldosterone can be cured by adrenal surgery, patients with bilateral disease receive life-long treatment with mineralocorticoid antagonists (1). Therefore, correct diagnosis and subsequent subtype differentiation are crucial for adequate clinical management. The current Clinical Practice Guideline of the Endocrine Society recommends screening by determination of the aldosterone/renin ratio (ARR) (1). Confirmatory testing can be accomplished by using the saline infusion test (SIT), captopril challenge, fludrocortisone suppression, or oral sodium loading (1). All of those tests differ regarding their reported sensitivity, specificity, and reliability; clear-cut evidence for one optimal confirmatory test is still lacking (6, 7, 8, 9).Local expertise, costs, patient compliance and laboratory routine guide the choice of the testing procedure (1). Among the available tests, SIT represents one of the most widely used ones which is most likely explained by its simplicity, safety profile, and cost effectiveness (10, 11). Notably, however, cut-off values to rule out PA by SIT are hampered by liabilities of currently used immunoassays (IA), which show low inter-assay agreement particularly in the low range of aldosterone concentration (12, 13, 14). This appears to be caused (at least in part) by cross-reactivity with other compounds and metabolites (15, 16, 17), particularly in patients with impaired renal function (18).Liquid chromatography tandem mass spectrometry (LC-MS/MS) has been introduced into the clinical routine analysis of steroid hormones (19, 20, 21) due to its higher specificity and is increasingly used for the diagnosis of adrenal diseases (22, 23, 24). Aldosterone concentrations measured with LC-MS/MS are usually lower than those measured by most IAs (15, 17, 25, 26, 27, 28). Guo et al. recently proposed a LC-MS/MS-specific cut-off for aldosterone during fludrocortisone suppression testing (28). Regarding SIT, however, LC-MS/MS-derived counterparts are still lacking.The current study aims to establish LC-MS/MS-specific threshold values for aldosterone during SIT and to determine their diagnostic accuracy for the presence of PA in a cohort of 187 SIT performed under standardized conditions at a single tertiary referral cente

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