Study characteristics |
Patient Sampling |
Case‐control study. 250 cases were extracted and a physician made the medical diagnoses. Medical evaluations were found in the data set Dataverse. |
Patient characteristics and setting |
The study included people with keratoconus and healthy controls. Further participant characteristics are described in Dataverse. |
Index tests |
Convolutional neural network using a 3D reconstruction of corneal images as input. The output was healthy or keratoconus. The algorithm also defined severity of keratoconus. |
Target condition and reference standard(s) |
The OCT SS‐1000 (CASIA) was used to make the corneal images. The diagnosis was made by a physician. All cases were diagnosed before the algorithm analysed the images. |
Flow and timing |
All cases were included in the reference standard and index test. All data were included in a 2 × 2 table. |
Comparative |
Not applicable |
Notes |
This research was funded by the Deanship of Scientific Research at Princess Nourah bint Abdulrahman University through the Fast‐track Research Funding Program. |
Methodological quality |
Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
DOMAIN 1: Patient selection |
Was a consecutive or random sample of patients enrolled? |
Unclear |
|
|
Was a case‐control design avoided? |
No |
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|
Did the study avoid inappropriate exclusions? |
Unclear |
|
|
Could the selection of patients have introduced bias? |
|
High risk |
|
Are there concerns that the included patients and setting do not match the review question? |
|
|
High |
DOMAIN 2: Index test (All tests) |
Were the index test results interpreted without knowledge of the results of the reference standard? |
Unclear |
|
|
If a threshold was used, was it pre‐specified? |
Unclear |
|
|
Was the model designed in an appropriate manner? |
Yes |
|
|
Could the conduct or interpretation of the index test have introduced bias? |
|
Unclear risk |
|
Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
|
|
Low concern |
DOMAIN 3: Reference standard |
Is the reference standard likely to correctly classify the target condition? |
No |
|
|
Were the reference standard results interpreted without knowledge of the results of the index tests? |
Yes |
|
|
Could the reference standard, its conduct, or its interpretation have introduced bias? |
|
High risk |
|
Are there concerns that the target condition as defined by the reference standard does not match the question? |
|
|
Unclear |
DOMAIN 4: Flow and timing |
Did all patients receive the same reference standard? |
Yes |
|
|
Were all patients included in the analysis? |
Yes |
|
|
Could the patient flow have introduced bias? |
|
Low risk |
|
DOMAIN 5: Comparative |