Zeboulon 2020a.
| Study characteristics | |||
| Patient Sampling | Retrospective, machine‐learning, experimental study. The Orbscan (Bausch & Lomb, Bridgewater, NJ) database was exported using the batch export functionality both as image files and the underlying numeric data matrixes represented by each colour map. They selected 3000 examinations in total, 1000 per class (normal, keratoconus, history of refractive surgery). All 3000 examinations were obtained from different people, and only 1 eye per person was selected. They balanced the examinations to have exactly 500 left eyes and 500 right eyes in each class. The selection process was as follows: consecutive examinations were preselected by a resident and reviewed by a corneal tomography expert. |
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| Patient characteristics and setting |
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| Index tests | The possibility of using numeric data matrixes instead of colour maps to train a convolutional neural network (CNN) for a classification task. Specifically, the investigators used 4 maps that are frequently used in clinical practice, stacked together as if they were 4 colour channels of a single image to classify examinations into 3 categories: normal, keratoconus, and history of refractive surgery. The training set was trained during 15 epochs with a learning rate of 0.0001 and a batch size of 2. |
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| Target condition and reference standard(s) | The diagnosis was made by a resident and corneal tomography specialist with at least 5 years of experience. The diagnosis was made before the convolutional neural network analysis. |
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| Flow and timing | All participants were diagnosed by 2 cornea specialists. All cases were included in the analysis. | ||
| Comparative | Not applicable | ||
| Notes | The study authors received no funds or support for the study. | ||
| 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? | 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? | Unclear | ||
| 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? | 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 | |||