Sideroudi 2017.
Study characteristics | |||
Patient Sampling | A cross‐sectional, observational study. Study participants were recruited from the cornea outpatient service in a consecutive if eligible basis; controls were refractive surgery candidates. 80 eyes formed the keratoconus group, 55 eyes formed the subclinical keratoconus group, and 50 normal eyes populated the control group. |
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Patient characteristics and setting |
Exclusion criteria: previous incisional eye surgery, corneal scars and opacities, history of herpetic keratitis, severe eye dryness, current corneal infection, glaucoma, suspicion of glaucoma, intraocular pressure‐lowering treatment, pregnancy or nursing, contact lens use, and underlying autoimmune disease. |
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Index tests | A self‐developed algorithm based on logistic regression in Visual Basic for Microsoft Excel performed a Fourier series harmonic analysis for the posterior corneal sagittal curvature data and evaluated the derived parameters in the diagnosis of Subclinical Keratoconus and Keratoconus. | ||
Target condition and reference standard(s) | The diagnosis of keratoconus was based on the Amsler‐Krumeich classification and tomography images; however, it was unclear who made the diagnosis. The diagnosis was made before the analysis with the AI algorithm. | ||
Flow and timing | It was unclear whether all included participants were diagnosed by the same person(s). All participants were included in the analyses. | ||
Comparative | Different algorithms were developed; it was unclear whether the results were interpreted separately. All data were included in the different analyses. | ||
Notes | No funding source mentioned. | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
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? | Yes | ||
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? | Unclear | ||
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? | Unclear risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
DOMAIN 4: Flow and timing | |||
Did all patients receive the same reference standard? | Unclear | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Unclear risk | ||
DOMAIN 5: Comparative | |||
Were different AI tests were developed and interpreted without knowledge of each other. | Unclear | ||
Are the proportions and reasons for missing data similar for all index tests? | Yes | ||
Unclear risk | |||