RadSTARD –Radiology Standards for the Reporting of Diagnostic Accuracy Studies Summary Document 1. TITLE &
ABSTRACT
Radiology Diagnostic Accuracy Trials should include the words "Diagnostic Accuracy" in the Title/Abstract. Use the term ‘diagnostic accuracy’ in the title of the study (STARD item # 1).
2. Radiology Diagnostic Accuracy Trials should explicitly state that the aim is to compare the index test with the reference standard for diagnosis of a specific condition. The aim is to
compare the index test to the reference standard (STARD item # 2).
3. METHODS, PATIENT ELIGIBILITY, DATA
COLLECTION
Radiology Diagnostic Accuracy Trials should provide inclusion and exclusion criteria. Details of setting and location of study (e.g. whether primary or secondary care) should be provided. Specify
whether patients studied were receiving primary or secondary care (STARD item # 3).
4. Radiology Diagnostic Accuracy Trials should indicate if participants had received either the index test or the reference standard. Specify if the participants received either the index test or the
reference standard (STARD item # 3).
5. Was patient selection consecutive or non-consecutive? Specify how participants were enrolled
(STARD item # 5).
6. Data collection (prospective or retrospective) should be provided with start dates and end dates. Record that data was collected as a chart review (retrospectively) or prospective analysis and
include the dates the study was done (STARD item # 6 and 14).
7. SAMPLE SIZE Sample size and limitations should be provided. Providing a sample size reflects the power of the
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8. DIAGNOSTIC TEST METHODS
Radiology Diagnostic Accuracy Trials should explicitly state the reference standard and its rationale.
Reporting the reference standard which is the test that is commonly used in medical practice. Rationale for its use should also be defined (STARD item # 7).
9. IMPERFECT REFERENCE STANDARD
If the Reference Standard is unavailable or imperfect, use of an alternative reference standard should be justified. There is no perfect reference standard – alternatives may consist of a panel
standard, composite reference standard, latent class analysis or intrinsic reference standard (not in STARD).
10. TEST Technical specifications for the index test and reference test should be reported in all radiology diagnostic accuracy studies. A thorough description of the index test and reference standard should
be provided so that the reader can interpret if the same test could be performed in their institution (STARD item # 8).
11. Sound theoretical physics basis of the index test should be provided for new techniques.
Description of physics for the index test is very pertinent to radiology to facilitate replication (not in STARD).
12. Modifications during the study should be reported if they occurred. Describe if the index test or
reference standard was modified as this could impact diagnostic accuracy and alter data analysis (not in STARD).
13. ANALYSIS Radiology Diagnostic Accuracy Trials should report cut-off values for specific diagnostic criteria for index and reference tests. It is important to specify which cut-off values were used for a specific
diagnosis (similar to STARD item # 9).
14. The training and number of investigators should be described including any extra training for new
techniques. Whether any extra training was required to interpret the index test should be known
(similar to STARD item # 10).
15. Whether readers were blinded to prior test results or clinical information should be known. The
blinding of interpreters is essential to prevent bias (STARD item # 11).
16. RESULTS Radiology Diagnostic Accuracy Trials should report study flow with a flow diagram, including eligible patients who did not undergo index or reference tests, and provide explanations. The provision of a
flow diagram clearly illustrates how many participants were tested or not resulting in final analysis (STARD item # 16).
17. Patient demographics including age, sex, presenting diagnosis or symptoms, any co-morbidities, and
concurrent therapies should be provided. The provision of concurrent therapies should be provided
as they may affect the interpretation of the tests (similar to STARD item # 15).
18. The severity (spectrum) of the disease entity should be explicitly reported. The time that a disease
was present or if was found by screening could impact how readily it is diagnosed (STARD item # 18).
19. The time difference between the index test and reference test and details of any other treatments
provided between the two tests should be provided. If there was a delay between the conduct of
either test this could impact their level of diagnostic accuracy (STARD item # 17).
20. Adverse events should be reported for either the index test or reference standard. It is important to
state if there were any incidents of adverse events when conducting either test (STARD item # 20).
21. STATISTICS Radiology Diagnostic Accuracy Trials should explicitly state measures of diagnostic accuracy and uncertainty (preferably p-values and 95% CI). Calculated confidence intervals and p-values define
how precise the estimates are for the population chosen under study (similar to STARD item # 21).
22. Radiology Diagnostic Accuracy Trials should report indeterminate/missing results and outliers for the
index test and reference standard; and describe how this data was handled. All indeterminate
results from the index test and the reference standard should be reported as ignoring such results can bias measures of diagnostic accuracy (similar to STARD item # 22).
23. Radiology Diagnostic Accuracy Trials should include estimates of inter-observer variability
including > 3 observers with variable expertise. A description of analysis that is planned should
be described apriori with > 3 observers of variable expertise as this will decrease inter-observer variability (similar to STARD item # 23).
24. Radiology Diagnostic Accuracy Trials should include estimates of test reproducibility. This is done by
stating the level of Kappa where the statistic impacts the level of intra and inter-observer variability (STARD item # 24).
25. DISCUSSION The clinical relevance of the study findings should be provided. Discussion could include comparing
and contrasting to previous studies plus describing any limitations to the current study (STARD item # 25).
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