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. 2023 Nov 15;2023(11):CD014911. doi: 10.1002/14651858.CD014911.pub2

Mahmoud 2021.

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    
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