ITEM 13. Describe methods for calculating test reproducibility, if done.
Example
Interobserver variability in the interpretation of conventional angiography and magnetic resonance angiography (MRA) were computed using the k statistic including 95% confidence intervals.[1]
The index test and the reference standard are seldom perfect. Their reproducibility varies, and limited reproducibility adversely affects diagnostic accuracy.[2]
Observer variability can arise with imaging tests when the reader must summarize visual observations in a statement about the presence of disease. It also arises during classification, when the reader must use the data to place patients into diagnostic categories.[3] Instrument variability concerns the amount of variation that arises during the operation of devices or systems, such as automated laboratory measurements. Other terms for this form of variation include imprecision, analytic methodological variation, or analytical noise (error). Poor reproducibility adversely affects diagnostic accuracy. If possible, authors should evaluate the reproducibility of the test methods used in their study and report their procedure to do so.
For quantitative assays, it is useful to report imprecision as the coefficient of variation at two or more specified mean values near clinical decision points as obtained by repeating the test over a specified number of days. Within-run coefficients of variation are appropriate if all patient samples were analyzed in a single run.
In the example, the authors used the kappa statistic to express interobserver variability for conventional angiography and MRA in the detection of renovascular disease.
References
1. |
Leung DA, Hoffmann U, Pfammatter T, et al. Magnetic resonance angiography versus duplex sonography for diagnosing renovascular disease. Hypertension 1999; 33:726-31. |
2. |
Quinn MF. Relation of observer agreement to accuracy according to a two-receiver signal detection model of diagnosis. Med Decis Making 1989; 9:196-206. |
3. |
Elmore JG, Feinstein AR. A bibliography of publications on observer variability (final installment). J Clin Epidemiol 1992; 45:567-80. |