Page 98 - Journal of Special Operations Medicine - Spring 2017
P. 98

An Ongoing Series



                              Basic Biostatistics and Clinical Medicine



                                         Joshua Banting; Tony Meriano, MD

          OBJECTIVES

          In this column of Clinical Corner, we are going to talk   Consider that you want to develop a test, a nonmedical
          about a higher-level concept and cover some basic bio-  test. You are trying to build a metal detector to screen
          statistics related to clinical medicine. It is not as exciting   people for weapons. It sends “rays” to screen a person
          as penetrating trauma, but it is essential for the elite-  for metal, which might indicate a weapon. We want to
          level clinician to understand because these concepts are   detect all the weapons that people have but we do not
          critical to taking your medical decision-making to the   want the machine to falsely identify zippers on clothes
          next level.                                        or coins in pockets. If we set the machine’s rays too low,
                                                             then we might not detect the metal present in a weapon.
          It is common for inexperienced medical personnel  to   If we set it too high, it will beep constantly and create
          think of medical tests to be binary, being either posi-  huge waiting lines because it is detecting items that are
          tive or negative. In actuality, it is not so simple. Even   not weapons.
          a simple qualitative test like a colormetric urine preg-
          nancy test is more complicated than this. It is true that   When a person walks through the scanner, four possibili-
          it can be positive or negative, but it must have a cutoff.   ties can occur. The machine can beep and we can find a
          This cutoff is the amount of detectable human chorionic   weapon; this is called a TP. The machine could also beep
          gonadotropin (hCG) in the urine that is able to change   but the person does not have a weapon; this is called
          the color of the strip. The manufacturer sets this cutoff   an FP. The machine could clear someone who does not
          to provide the highest yield, and this yield is defined by   have a weapon, which is a TN. However, if someone
          the terms “sensitivity” and “specificity.”         gets through with a weapon without the machine detect-
                                                             ing the weapon, that would be called an FN. These four
                                                             possibilities can be represented in a grid (Figure 1). Ulti-
          Sensitivity and Specificity
                                                             mately, to calculate SN and SP, you need a secondary test
                                                             to confirm the results of the first test. In our theoretical
             Sensitivity (Sn) measures how often the test will   example, this would be a pat-down search. This type of
             be positive in a person with the disease. More for-  confirmatory test is often called the gold standard.
             mally, it is a measure of the number of true posi-
             tives (TPs) of the total number of diseased persons   This is SN and SP: super high SN will detect all metal
             including those whom the test identifies as falsely   but every person would be pulled out. Super high SP will
             negative.                                       not accidentally identify spare change as a weapon but
                                   TPs                       might miss a true firearm. All ideal tests, even medical
                    Sn =                                     ones, have a combination of high SN and high SP.
                         (TPs + false negatives [FNs])
                                                             Tests with a high degree of SN can be used (with your
               Specificity (Sp) measures how often a test will be   clinical judgment) to rule out a medical condition. For
             negative in a person without disease. It measures   example, a serum hCG has a high SN. If it is negative,
             the number of TNs correctly identified by a test   it is most likely that a woman is not pregnant. This is
             of the total of disease-free persons including those   commonly written as sensitivity rules out, or “Sn-out.”
             whom the test identifies as falsely positive.
                                   TNPs                      Tests with a high degree of AP can be used (with your
                  Sp =                                       clinical judgment) to  rule in a medical condition. For
                       TNs/(TNs + false positives [FPs])     instance, a positive Western blot test for HIV infection
                                                             is highly specific. This is sometimes written as “Sp-in.”



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