Diagnosis Studies

Levels of Evidence
DIAGNOSIS STUDIES
Concerned with the rigorous development and evaluation of formal instruments to screen, diagnose and
assess patients and to measure important clinical outcomes.
High quality instruments with documented accuracy are essential both for clinical practice and for
further research.
When a nurse wants to answer a question about the usefulness, accuracy, selection, or interpretation of
a particular measurement instrument or laboratory test, he or she will select studies that have the
following characteristics:
 Cross-sectional study design with people suspected to have the condition of interest.
 Administration to the patient of both the new instrument or diagnostic test and the accepted
“gold standard” measure.
 Comparison of the results of the new instrument or test and the “gold standard”
In these articles, investigators study the ability of screening or diagnostic tests, tools, or components of
clinical examination to detect (or not detect)disease when the patient has (or does not have) the
particular disease of interest.

MEASURES OF ACCURACY
CHARACTERISTICS OF THE TEST
Sensitivity
It is the ability of the test to detect the proportion people with the disease or disorder of interest; that
is, sensitivity is a measure of how well the test detects disease when it is really there; a sensitive test has
few false negatives.
Formula:
Sensitivity= TP/(TP+FN)
TP=number of true positive results
FN=number of false negative results

Specificity
It is the ability of the test to detect the proportion of people without the disease or disorder of interest.
It measures how well the test rules disease when it is really absent; a specific test has few false
positives.
Formula:
Specificity= TN/(TN+FP)
TN=number of true negative results
FP=number of false positive results

PREDICTIVE VALUES
Determines how well a test performs and how frequent or infrequent the target disorder occurs in the
tested population.

Positive Predictive Value

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This is the proportion of people with a positive test who have the target disorder.
Formula:
PPV= TP/(TP+FP)

Negative Predictive Value

This is the proportion of people with a negative test who do not have the target disorder.
Formula:
NPV=TN/(TN+FN)

LIKELIHOOD RATIO
Is a measure that a given test result would be expected in a patient with the target disorder compared
to the likelihood that the same result would be expected in a patient without the target disorder. It
measures the power of the test to change the pretest into the posttest probability of a disease being
present.

Positive likelihood Ratio

The likelihood ratio of a positive test tells us how well a positive test result does by comparing its
performance when the disease is present to that when it is absent. The best test to use for ruling in a
adisease is the one with the largest likelihood ratio of a positive test.
Formula:
PLR= sensitivity/(1-specificity)

Negative Likelihood Ratio

The LR of a negative test tells us how well a negative test result does by comparing its performance
when the disease is absent to that when it is present. The better test to use to rule out disease is the
one with the smaller likelihood ratio of a negative test
Formula:
(1-sensitivity)/specificity

EXAMPLE:
NITRITE RESULTS INDICATIVE FOR BACTERURIA USING THE DIPSTICK /PAD METHOD
Researchers compared a new method of pressing a urine dipstick into a wet incontinence pad and
compared this method with the “gold standard” of sending a clean-catch specimen to a laboratory for
culture

(Gold standard) Culture results

Positive Negative Totals
Dipstick/Pad Positive 19 (TP) 2 (FP) 21
(New test) Negative 8 (FN) 69 (TN) 77
Totals 27 71 98

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Calculations:

Sensitivity= TP/(TP+FN)
= 19/(19+8) = 19/27= .70 or 70%
Interpretation:
The dipstick/pad method is 70% accurate in detecting the proportion of patients with positive tests as
having bacteruria.

Specificity= TN/(TN+FP)
= 69/(69+2) = 69/71= .972 or 97%
Interpretation:
The dipstick/pad method is 97% accurate in detecting the proportion of patients with negative test as
not having bacteruria.

Prevalence of bacteruria in this population (elderly, primarily female nursing home residents)=27/98
= .275 or 28 %
Interpretation:
Prevalence of bacteruria in this population is 28%

Positive predictive value= TP/(TP+FP)

= 19/(19+2)= 19/21= .90 or 90%
Interpretation:
90% of primarily elderly female nursing home residents with a positive dipstick/pad method will have
bacteruria. 10% will not have bacteruria

Negative predictive value= TN/(TN+FN)

= 69/(69+8) = 69/77 = .896 or 90%
Interpretation:
90% of primarily elderly female nursing home residents with a negative dipstick/pad method will not
have bacteruria. 10% will have bacteruria.

Postive likelihood ratio= sensitivity/(1-specificity)

= .70/(1-.972)= .70/ .028 = 25
Interpretation:
A large LR+. A positive dipstick/pad method test will change the posttest odds of the patient having
bacteriuria.

Negative likelihood ratio= (1-sensitivity)/specificity

= (1-0.72)/.97= .29
Interpretation:
A large LR-. A negative dipstick/pad method test will dramatically change the posttest odds of the
patients not having bacteruria.

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References:
Essentials of Nursing Research by Denise Polit
LoBiondo-Wood, G.; Haber, J. Nursing Research: Methods and Critical Appraisal for Evidence-Based
Practice. 2006, Mosby Inc.