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DOI:10.2214/AJR.07.7004
AJR 2008; 190:S29-S34
© American Roentgen Ray Society

Methodology and Application of Prospective Reader Studies: Self-Assessment Module

Elizabeth A. Krupinski1, William C. Black2 and Felix S. Chew3

1 Department of Radiology Research, University of Arizona, Tucson, AZ.
2 Department of Radiology, Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH.
3 Department of Radiology, University of Washington, Box 354755, 4245 Roosevelt Way, NE, Seattle, WA 98105.

Received May 7, 2007; accepted after revision August 7, 2007.

 
Address correspondence to F. S. Chew (fchew{at}u.washington.edu).


Abstract
Top
Abstract
INTRODUCTION
EDUCATIONAL OBJECTIVES
REQUIRED READING
RECOMMENDED READING
INSTRUCTIONS
QUESTION 1
QUESTION 2
QUESTION 3
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References
 
The educational objectives of this self-assessment module are for the participant to read selected sources on prospective reader study methodologies and to self-assess and improve his or her knowledge of this subject.

Keywords: prospective reader studies • receiver operating characteristic • ROC analysis • self-assessment


INTRODUCTION
Top
Abstract
INTRODUCTION
EDUCATIONAL OBJECTIVES
REQUIRED READING
RECOMMENDED READING
INSTRUCTIONS
QUESTION 1
QUESTION 2
QUESTION 3
QUESTION 4
QUESTION 5
QUESTION 6
QUESTION 7
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QUESTION 11
References
 
This self-assessment module on prospective reader study methodologies has an educational component and a self-assessment component. The education component consists of four required articles that the participant should read. The self-assessment component consists of 11 multiple choice questions with solutions. All of these materials are available on the ARRS Web site (www.arrs.org).


EDUCATIONAL OBJECTIVES
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Abstract
INTRODUCTION
EDUCATIONAL OBJECTIVES
REQUIRED READING
RECOMMENDED READING
INSTRUCTIONS
QUESTION 1
QUESTION 2
QUESTION 3
QUESTION 4
QUESTION 5
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References
 
By completing this educational activity, the participant will:

  1. Understand the meaning and relevance of sample size and statistical power when designing reader studies as they pertain to both readers and images.
  2. Understand the different types of study designs that can be used to conduct prospective reader studies as well as other measures of performance such as workflow.
  3. Recognize when a receiver operating characteristic (ROC) study is appropriate and what types of research questions it can answer.
  4. Understand the basic nature of the receiver operating characteristic (ROC) technique: use of rating scales, the ROC curve, area under the ROC curve (Az or AUC), and interpreting metrics of performance.
  5. Differentiate between true and false, positive and negative decisions.
  6. Distinguish between the common metrics of reader performance, including sensitivity and specificity, accuracy, and positive and negative predictive values.
  7. Recognize the importance of critical design issues in reader studies: reader experience, training, time between trials, types of images and types and subtlety of lesions, and environmental and viewing conditions.


REQUIRED READING
Top
Abstract
INTRODUCTION
EDUCATIONAL OBJECTIVES
REQUIRED READING
RECOMMENDED READING
INSTRUCTIONS
QUESTION 1
QUESTION 2
QUESTION 3
QUESTION 4
QUESTION 5
QUESTION 6
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References
 

  1. Berger WG, Erly WK, Krupinski EA, Standen JR, Stern RG. The solitary pulmonary nodule on chest radiography: can we really tell if the nodule is calcified? AJR 2001; 176:201–204
  2. Eng J. Receiver operating characteristic analysis: a primer. Acad Radiol 2005;12:909–916
  3. Kundel HL. History of research in medical image perception. J Am Coll Radiol 2006; 3:402–408
  4. Metz CE. Receiver operating characteristic analysis: a tool for the quantitative evaluation of observer performance and imaging systems. J Am Coll Radiol 2006; 3:413–422


RECOMMENDED READING
Top
Abstract
INTRODUCTION
EDUCATIONAL OBJECTIVES
REQUIRED READING
RECOMMENDED READING
INSTRUCTIONS
QUESTION 1
QUESTION 2
QUESTION 3
QUESTION 4
QUESTION 5
QUESTION 6
QUESTION 7
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References
 

  1. Alpert HR, Hillman BJ. Quality and variability in diagnostic radiology. J Am Coll Radiol 2004; 1:127–132
  2. Metz CE. Some practical issues of experimental design and data analysis in radiological ROC studies. Invest Radiol 1989; 24:234-245
  3. Metz CE. Basic principles of ROC analysis. Semin Nucl Med 1978; 8:283–298
  4. Patton DD. Introduction to clinical decision making. Semin Nucl Med 1978; 8:273–282
  5. Swets JA. ROC analysis applied to the evaluation of medical imaging techniques. Invest Radiol 1979; 2:109–121
  6. van Erkel AR, Pattynama PMT. Receiver operating characteristic (ROC) analysis: basic principles and applications in radiology. Eur J Radiol 1998; 27:88–94


INSTRUCTIONS
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Abstract
INTRODUCTION
EDUCATIONAL OBJECTIVES
REQUIRED READING
RECOMMENDED READING
INSTRUCTIONS
QUESTION 1
QUESTION 2
QUESTION 3
QUESTION 4
QUESTION 5
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References
 

  1. Complete the required reading.
  2. Visit www.arrs.org and select Publications/Journals/SAM articles from the left-hand menu bar.
  3. Using your member login, order the online SAM as directed.
  4. Follow the online instructions for entering your responses to the self-assessment questions and complete the test by answering the questions online.


QUESTION 1
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Abstract
INTRODUCTION
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INSTRUCTIONS
QUESTION 1
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References
 
Receiver Operating Characteristic (ROC) analysis techniques are often applied to studies of medical decision-making, especially in studies evaluating the impact of imaging technology on diagnostic accuracy. The theoretical framework underlying ROC analysis is best described by which of the following?

  1. How people encode, store, and retrieve information.
  2. How people make dichotomous decisions under conditions of uncertainty.
  3. How people identify objects, make decisions regarding their similarity, and make preference judgments.
  4. How people make current decisions based on the outcome of previous decisions.
  5. How people reduce the inherent uncertainty in information when they transmit it.


QUESTION 2
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Abstract
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References
 
In which of the following scenarios would ROC analysis be appropriate?

  1. An investigator wishes to determine whether a new MRI reconstruction method improves the speed with which diagnostic decisions are rendered.
  2. An investigator wants to determine whether radiology technicians are at greater risk of cancer than the general population because of their exposure to ionizing radiation.
  3. An investigator wishes to determine whether radiologists can accurately detect calcification in pulmonary nodules with chest radiography.
  4. An investigator wishes to examine the impact of a new drug on the survival rates of patients.
  5. An investigator wishes to examine whether radiologists are more comfortable using a mouse or trackball as an interface device for soft-copy reading.


QUESTION 3
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Abstract
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References
 
Referring to Figure 1, which of the ROC curves (labeled A–E) represents an "improper" ROC curve or one that should be recalculated using "proper" methods?


Figure 1
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Fig. 1 Set of ROC curves. True-positive fraction (sensitivity) is plotted along vertical axis, and false-positive fraction (1–sensitivity) is plotted along horizontal axis.

 
  1. A.
  2. B.
  3. C.
  4. D.
  5. E.


QUESTION 4
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INTRODUCTION
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INSTRUCTIONS
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References
 
Referring to Figure 1, which of the ROC curves represents the best performance?

  1. A.
  2. B.
  3. C.
  4. D.
  5. E.


QUESTION 5
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Abstract
INTRODUCTION
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REQUIRED READING
RECOMMENDED READING
INSTRUCTIONS
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References
 
One of the simplest metrics of diagnostic performance is accuracy (fraction of cases that are reported correctly). What is the main problem with using accuracy to report diagnostic performance?

  1. Disease prevalence affects accuracy.
  2. Sensitivity and specificity are not mathematically related to accuracy.
  3. Calculating accuracy requires the use of calculus.
  4. You cannot combine accuracy for multiple readers to get an overall measure of accuracy.
  5. The number of cases affects accuracy.


QUESTION 6
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References
 
When choosing cases for an evaluation of observer performance, investigators typically select cases with only a single lesion. What is one main reason for doing this?

  1. Using more than one abnormality per patient would be unrealistic.
  2. Investigators are trying to avoid the satisfaction of search phenomenon.
  3. ROC analysis cannot be used when there is more than one lesion.
  4. Having more than one abnormality would increase the false-positive rate.
  5. Less experienced observers cannot be expected to find multiple lesions.


QUESTION 7
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Abstract
INTRODUCTION
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References
 
When collecting a set of cases to include in a study of observer performance, why is it important to consider the number of cases to be included?

  1. It is necessary to replicate the typical reading volume a radiologist experiences.
  2. It is necessary to replicate the disease prevalence.
  3. If you select too many cases, observers may become fatigued, resulting in underestimation of their true performance.
  4. Adequate sample size is necessary to achieve adequate statistical power.
  5. Having too few cases does not give observers enough time understand the experimental task.


QUESTION 8
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References
 
When collecting a set of cases for an observer performance evaluation study, what is the best method to establish truth (or the reference standard) about whether a case contains an abnormality?

  1. Ask a senior person to read all the cases and use those responses as truth.
  2. Use the original official report for the case as truth.
  3. Ask someone outside your institution to read the cases and use that as truth.
  4. Let the lead investigator decide what truth is for each case since he or she is responsible for the study.
  5. Use clinical or pathologic data and follow-up results to establish truth.


QUESTION 9
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References
 
An investigator wants to add one of two new image-processing methods to a PACS workstation. An earlier ROC study showed both methods to yield equivalent observer performance. What type of study could be done to show that one method versus the other affects reading efficiency?

  1. Ask a set of clinicians which processing technique makes a set of images look better.
  2. Process the same image with both techniques, display side by side, and ask a set of clinicians to report which technique they would prefer to use.
  3. Let the engineer who developed the techniques decide which one will be better in clinical use.
  4. Have a set of clinicians interpret images processed with both techniques and time how long it takes for them to render a decision.
  5. Put them both on the PACS workstation and record which technique is used more often.


QUESTION 10
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References
 
Readers of medical images can often be characterized as either conservative or liberal in their interpretations or use of decision thresholds. Which set of results characterizes a more conservative reader?

  1. High true positives and high false positives.
  2. Low true positives and low false positives.
  3. High true positives and low false positives.
  4. Low true positives and high false positives.
  5. Equal amounts of true and false positives.


QUESTION 11
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References
 
The National Council on Radiation Protection and Measurements scientific council under the guidance of Fryback & Thornbury developed a six-level hierarchical model for the diagnostic efficacy of imaging technology. Which of the following best describes the basis of model?

  1. Complexity of the output, ranging from a single projection image to a computer-interactive multidimensional fused image set.
  2. Direct cost of the technology, ranging from low cost of equipment and low cost to perform an examination to high cost of equipment and high cost to perform an examination.
  3. Rate of adoption of the technology, ranging from select academic centers to widespread use in the community.
  4. Cost-effectiveness of the technology, ranging from not at all cost effective (high cost, low effectiveness) to very cost effective (low cost, high effectiveness).
  5. Scope of effectiveness, ranging from effective at the technical level to effective at a societal level when widely disseminated.

Solution to Question 1
All of these options refer to theories regarding the way humans process information and render decisions. How people make decisions under conditions of uncertainty refers to signal detection theory. Signal detection theory deals specifically with the principle of signal detection (i.e., detecting a signal or target (e.g., tumor) in a background of noise (e.g., chest anatomy), and considers both perception and decision-making [1]. Signal detection theory is the underlying basis for ROC analysis. The best response is Option B. The stages by which people encode, store, and retrieve information refers to information processing theory. It specifies four types of knowledge: general versus specific (useful in many tasks or specific ones), declarative (facts), procedural (how to), and conditional (when and how). Option A is not the best response. The perceptually based theory that attempts to explain the way people identify objects, make decisions regarding their similarity, and make preference judgments is called General Recognition Theory. It has more to do with decision classification processes that occur after a target (lesion) has been detected, and not with the detection of the target itself. Option C is not the best response. How people make current decisions based on the outcome of previous decisions may be described by Bayesian decision theory. Bayesian decision theory is a specific type of decision theory that uses some prior distribution of data in the computation of the present decision, often taking utilities into account. This theory does not address perception. Option D is not the best response. The transmission of information and ways to reduce the inherent uncertainty in information refers to information systems theory. Information systems theory proposes a three-stage process to eliminate uncertainty through enactment (do something with the information), selection (decide which information to keep and which to ignore) and retention (what needs to be remembered). This theory does not address perception. Option E is not the best response.

Solution to Question 2
An investigator wishes to determine whether radiologists can accurately detect calcification in pulmonary nodules with chest radiography. ROC analysis is used to assess decision accuracy in diagnostic detection tasks [2]. In a typical ROC study, observers are presented with a set of images, half containing a target of interest (e.g., a tumor) and half without any target (e.g., normal chest image). Ideally, the set should contain a mix of subtle to moderately subtle targets. The images are randomized and each observer views the set in a given condition being tested (e.g., soft-copy display with and without edge enhancement applied). The observer is asked to search each image and report whether a lesion or target is present or absent. Observers then report their confidence in that decision using either a discrete (5-or 6-point) or continuous (0–100) scale. The confidence ratings are then used to generate the ROC curve, and the area under the curve can be calculated using standard methods. Option C is the best response. To measure speed the investigator would use a stopwatch and compare times using a t test. Option A is not the best response. To compare risk or relative risk of a group compared with the general population, one would use relative risk analysis techniques. Option B is not the best response. To study the impact of a drug on patient survival, one would use survival analysis techniques. Option D is not the best response. To examine tool use, such as a mouse versus trackball, one would rely on human factors analysis techniques such as a time–motion study. Option E is not the best response.

Solution to Question 3
The ROC curve is not supposed to dip below the chance line (D) as curve C does. Option C is the best response. The chance line defines an observer who is essentially guessing about the status of an image and is, therefore, operating at chance (would call half the images normal and half abnormal). The area under the chance line by definition is 0.50. Ideally, an observer who is qualified to carry out the experimental task and who understood the reporting instructions should perform better than chance and thus should have a resulting area under the curve higher than 0.50 (where 1.0 is perfect performance). Proper ROC methods have been developed to prevent this from occurring [3]. Curves A and B do not cross the chance line. Curve E falls below the chance line, typically indicating that the observer was not following the reporting instructions correctly (i.e., if the reporting scale used 1 = present, definite confidence; and 6 = absent, definite confidence, but the reader used 1 = absent, definite confidence; and 6 = present, definite confidence).

Solution to Question 4
The closer an ROC curve is to the upper left corner, the better performance is as generally measured by the area under the ROC curve (Az) [4]. Option A is the best response. In ROC space, the area above the chance line (D) equals 0.50. The chance line defines an observer who is essentially guessing about the status of an image and is therefore operating at chance (would call half the images normal and half abnormal). The area under the chance line by definition is 0.50. Ideally, an observer who is qualified to carry out the experimental task and who understood the reporting instructions should perform better than chance and thus should have a resulting area under the curve higher than 0.50 (where 1.0 is perfect performance). Perfect performance (Az = 1.0) would be indicated by an ROC curve that follows precisely the left and upper lines. Curve B represents performance intermediate between A and C. Curve E represents performance below chance, typically indicating that the observer was not following the reporting instructions correctly.

Solution to Question 5
If a disease is relatively rare, occurring in only 5% of patients, then a clinician who calls all the cases negative will have an accuracy of 95%, which is misleading [4]. Option A is the best response. Option B is incorrect because you can derive sensitivity and specificity from accuracy. Option C is incorrect because accuracy is simply reported as a percentage and does not require calculus. Option D is incorrect because the number of cases in a test set does not by itself affect accuracy, although using too many cases in one setting could lead to reader fatigue, which could decrease accuracy. Knowledge of disease prevalence (or prior probability) in general can affect the decision criteria of a clinician. For example, coccidioidomycosis (valley fever) is caused by an organism found in the soil in the southwestern United States and affects primarily the lungs (nodules are observed). A clinician in New England who sees a patient with nonspecific nodules is unlikely to consider coccidioidomycosis and thus misread the case of a patient who did not inform the clinician that he or she just returned from a vacation in Arizona. However, a clinician in Arizona, seeing the same nodular manifestations, would be more likely to correctly consider coccidioidomycosis as the diagnosis.

Solution to Question 6
In satisfaction of search, observers do not report additional findings on images when they have found something suggested by the original search task [5]. For example, if the main task is searching for nodules in chest images, the presence of a rib fracture often goes unreported once the nodule is detected. Option B is the best response. Option A is not the best response because many patients do have multiple lesions per examination. Option C is not the best response because there are ROC techniques (e.g., free-response ROC, alternative free-response ROC) designed specifically to account for multiple lesions. More than one lesion does not tend to increase the false-positive rate, so Option D is not the best response. Option E is not the best response because residents are trained from the beginning to search for and detect multiple lesions per case.

Solution to Question 7
Statistical power is the probability that one can reject the null hypothesis (there is no difference between conditions being compared) when it is indeed false (there is a true difference between conditions). Typically, one wants a power of about 0.80, meaning that the probability that one can reject the null hypothesis as a result of the study is 80% [6]. Statistical power is affected significantly by sample size—the greater the sample size, the more power one typically has. Option D is the best response. Replicating reading volume (option A) is impractical, as is trying to replicate (option B) prevalence (e.g., in screening mammography one may have one abnormal case per 1,000). Although using too many cases may tire the readers and impair their performance (option C), this is not the main reason to consider the sample size; rest breaks can always be incorporated into the protocol to address reader fatigue. Having clear written instructions should avoid observer confusion (option E) regarding the task no matter how many cases are used.

Solution to Question 8
An independent assessment of truth using other types of clinical data is always preferred when these sources of data are available [7]. Option E is the best response. All of the other choices rely on a single observer to decide truth, and that observer may be biased or simply incorrect. If other clinical data are not available to serve as the reference standard, the next best option is typically a panel of experienced clinicians.

Solution to Question 9
Only option D, the correct response, actually records an objective measure of reader efficiency—time required to render a decision [8]. All of the other methods rely on the subjective opinion of individual observers about perceived image appearance and do not assess reading efficiency.

Solution to Question 10
A conservative reader typically adopts a relatively high decision threshold (must have a lot of evidence to report an abnormality as present), resulting in fewer positive decisions (both true positive and false positive) than a more liberal reader [9]. Option B is the best response. A liberal reader has a lower decision threshold and thus is characterized by option A. Because the decision threshold affects both true-and false-positive decisions the same way (when one goes up the other does also), options C, D, and E rarely occur in experimental settings.

Solution to Question 11
The best response is E. The Fryback and Thornbury model is based on the effectiveness of the technology, viewed from six different perspectives or levels [10]. The levels are technical, diagnostic, diagnostic thinking, therapeutic, patient outcome, and societal. A diagnostic test is considered technically effective if its result is accurate and precise in a physical sense [11]. Diagnostic efficacy concerns the extent to which the results of a diagnostic test agree with patients' actual states of health. Diagnostic-thinking efficacy is difficult to measure but is the extent to which a diagnostic test affects physicians' subjective estimates of disease likelihood. Therapeutic efficacy addresses the question of how and by how much does a particular diagnostic test change the way in which patient are treated. Patient-outcome efficacy refers to whether a patient's health is demonstrably improved by use of the test. Societal efficacy merges private and public considerations (e.g., cost/benefit/effectiveness) to assess diagnostic tests within the context of the social endeavor. This framework is valuable in today's clinical environment because it acknowledges that it is no longer sufficient to simply demonstrate that a new technology can better depict anatomy, function, disease, etc., and thereby improve diagnostic accuracy. The decision whether to adopt or forego a new technology also depends on its cost, not only in the monetary sense but also in the societal sense, and the outcomes affected by the new technology. The Fryback and Thornbury model does not consider the complexity of the technology or the rate of adoption of the technology. Options A and C are not the best responses. Their model only indirectly considers the direct cost and the cost-effectiveness of a technology in the context of society efficacy, but their model is not based on these considerations. Options B and D are not the best responses.


References
Top
Abstract
INTRODUCTION
EDUCATIONAL OBJECTIVES
REQUIRED READING
RECOMMENDED READING
INSTRUCTIONS
QUESTION 1
QUESTION 2
QUESTION 3
QUESTION 4
QUESTION 5
QUESTION 6
QUESTION 7
QUESTION 8
QUESTION 9
QUESTION 10
QUESTION 11
References
 

  1. Swets JA, Pickett RM. Evaluation of diagnostic systems: methods from signal detection theory. New York, NY: Academic Press; 1982
  2. Berger WG, Erly WK, Krupinski EA, Standen JR, Stern RG. The solitary pulmonary nodule on chest radiography: can we really tell if the nodule is calcified? AJR 2001;176 : 201–204[Abstract/Free Full Text]
  3. Pan X, Metz CE. The "proper" binormal model: parametric receiver operating characteristic curve estimation with degenerate data. Acad Radiol 1997;4 : 380–389[CrossRef][Medline]
  4. Metz CE. Basic principles of ROC analysis. Semin Nucl Med 1978; 8:283 –298[Medline]
  5. Kundel HL. History of research in medical image perception. J Am Coll Radiol 2006;3 : 402–408[CrossRef][Medline]
  6. Metz CE. Some practical issues of experimental design and data analysis in radiological ROC studies. Invest Radiol1989; 24:234 –245[Medline]
  7. Revesz G, Kundel HL, Bonitatibus M. The effect of verification on the assessment of imaging techniques. Invest Radiol1983; 2:194 –198
  8. Krupinski EA, Roehrig H, Dallas W, Fan J. Differential use of image enhancement techniques by experienced and inexperienced observers. J Digit Imaging 2005;18 : 311–315[CrossRef][Medline]
  9. Patton DD. Introduction to clinical decision making. Semin Nucl Med 1978;8 : 273–282[Medline]
  10. Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making. 1991Apr–Jun; 11:88 –94[Abstract/Free Full Text]
  11. Metz CE. Receiver operating characteristic analysis: a tool for the quantitative evaluation of observer performance and imaging systems. J Am Coll Radiol 2006;3 : 413–422[CrossRef][Medline]

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