Xie 2020.
| Study characteristics | |||
| Patient Sampling | Retrospective, case‐control study, including people throughout China who wanted to undergo refractive surgery, had a primary diagnosis of keratoconus, and had stable postoperative refractive states. In total, 6465 corneal tomographic images from 1385 people were collected to develop the AI model. |
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| Patient characteristics and setting | The following groups were included: normal cornea, suspected irregular cornea, early‐stage keratoconus, keratoconus, and myopic postoperative cornea.
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| Index tests | InceptionResNetV2 architecture in a convolutional neural network on the TensorFlow platform to create the AI model with transfer learning technique. The algorithm uses a deep learning algorithm with corneal tomographic imaging and divides the images into the previously mentioned groups. This model may aid in identifying at‐risk corneas and determining which people are unsuited to corneal refractive surgery, thereby assisting in surgery decision‐making. | ||
| Target condition and reference standard(s) | The expert team included 3 senior ophthalmologists with at least 5 years of practical experience in the refractive surgery centre of the study clinic. Each image was independently labelled by the 3 experts, none of whom knew the labels selected by the others. When the labels differed, that chosen by 2 of the 3 experts was selected as the standard. |
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| Flow and timing | The data from all participants were checked by 3 ophthalmologists. The diagnosis was made before the analysis with the AI algorithm. | ||
| Comparative | Not applicable | ||
| Notes | The research received funding through grants 2018YFC0116500 from the National Key R&D Program of China, 31671000 from the Natural Science Foundation of China, 201804020007 from the Guangzhou Science and Technology Planning Project, 81822010 from the National Natural Science Foundation of China, 2018B010109008 from the Science and Technology Planning Projects of Guangdong Province, and 2017TX04R031 from the Guangdong Science and Technology Innovation Leading Talents. | ||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient selection | |||
| Was a consecutive or random sample of patients enrolled? | No | ||
| 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? | 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? | Low 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? | Yes | ||
| 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? | Low 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 | |||