Gairola 2022.
Study characteristics | |||
Patient Sampling | Single‐centre, retrospective, case‐control study. First data set (64 participants, 114 eye samples) obtained from topography device, SmartKC at the Sankara Eye Hospital in Bengaluru, India. Second data set (2110 samples; 1637 non‐keratoconus and 473 keratoconus) consisted of downloaded anonymized data from the Keratron device database for all the people who took the corneal topography examination at the hospital from April 2008 to May 2010. | ||
Patient characteristics and setting |
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Index tests | Convolutional neural network. The network is organized into 2 branches – 1 each for axial and tangential heatmaps – with a shared convolutional backbone, followed by 2 distinct feed‐forward classifiers, 1 for each branch. The shared backbone comprises the convolutional layers from a ResNet34 model. The model has a 2‐class (keratoconus versus non‐keratoconus) classification task. The article provides a clear explanation of the model and training procedure. |
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Target condition and reference standard(s) | The first data set was diagnosed by 1 senior ophthalmologist at the hospital. The diagnoses in the second data set were obtained based on the PPK‐based classification. | ||
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 | 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? | Unclear | ||
Was a case‐control design avoided? | No | ||
Did the study avoid inappropriate exclusions? | No | ||
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? | Low concern | ||
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 | |||
Were different AI tests were developed and interpreted without knowledge of each other. | |||
Are the proportions and reasons for missing data similar for all index tests? | |||