Maeda 1995a.
Study characteristics | |||
Patient Sampling | Single‐centre, case‐control study. Corneal topographic maps of the TMS‐1 were drawn from the Louisiana State University Eye Center patient population. | ||
Patient characteristics and setting | Maps from 176 eyes of 125 people were selected and grouped as follows.
Maps of eyes with keratoconus were selected from the charts of people previously diagnosed as having keratoconus in our clinic. |
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Index tests | Combined discriminant analysis and classification tree, based on topographic images. The algorithm determined whether a keratoconus‐like pattern was seen in a particular map in the binary classification tree and, if so, reported a value between 5% and 95% in proportion to the linear discriminant function to quantify the severity of the keratoconus pattern. | ||
Target condition and reference standard(s) | Topography images were made with the TMS‐1. It is unclear who diagnosed the cases; however, the diagnosis was made before the algorithm analysed the images. | ||
Flow and timing | It is unclear whether all eyes were diagnosed with the same reference standard. All data were included in a 2 × 2 table. | ||
Comparative | Not applicable | ||
Notes | This study was supported in part by US Public Health Service grants EY03311 and 02377 from the National Eye Institute, National Institutes of Health, Bethesda, Md; an unrestricted departmental grant from Research to Prevent Blindness Ine, New York, NY; and funds from Computed Anatomy Ine, New York, NY, and Menicon Co, Ltd, Nagoya, Japan. The Conecare data analysis software used in this study was provided courtesy of Yaron S. Rabinowitz, MD. | ||
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? | 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? | 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? | 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 |