Study characteristics |
Patient Sampling |
Retrospective, multicentre, case‐control study. 165 eyes of 120 subjects were included at 2 centres in Japan. |
Patient characteristics and setting |
People with keratoconus or keratoconus suspect comprised the keratoconus group.
People with post‐photorefractive keratectomy or with‐the‐rule astigmatism and people without disease comprised the non‐keratoconus group.
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Index tests |
Fourier‐incorporated keratoconus detection Index (FKI) created performing a logistic regression analysis with a training set to differentiate the keratoconus group from the non‐keratoconus group. The index is based on information obtained by Fourier analysis from not only the anterior corneal surface but also from the posterior corneal surface and corneal thickness. |
Target condition and reference standard(s) |
Corneal topographic analysis was performed with a slit‐scanning corneal topographer (Orbscan II, Bausch & Lomb). It is unclear how the diagnosis was made; however, cases were classified before the inclusion. |
Flow and timing |
It is unclear if all cases received the same reference standard. All data were included in a 2 × 2 table. |
Comparative |
Not applicable |
Notes |
This study was supported in part by Grant‐in‐Aid No.15591854 for Scientific Research from the Japanese Ministry of Education, Culture, Sports, Science and Technology (N. Maeda), and by a research grant from the Osaka Eye Bank Foundation, Suita, Japan (N. Maeda). |
Methodological quality |
Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
DOMAIN 1: Patient selection |
Was a consecutive or random sample of patients enrolled? |
No |
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Was a case‐control design avoided? |
No |
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Did the study avoid inappropriate exclusions? |
Unclear |
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Could the selection of patients have introduced bias? |
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High risk |
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Are there concerns that the included patients and setting do not match the review question? |
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High |
DOMAIN 2: Index test (All tests) |
Were the index test results interpreted without knowledge of the results of the reference standard? |
Yes |
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If a threshold was used, was it pre‐specified? |
No |
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Was the model designed in an appropriate manner? |
Yes |
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Could the conduct or interpretation of the index test have introduced bias? |
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Low risk |
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Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
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Low concern |
DOMAIN 3: Reference standard |
Is the reference standard likely to correctly classify the target condition? |
Unclear |
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Were the reference standard results interpreted without knowledge of the results of the index tests? |
Yes |
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Could the reference standard, its conduct, or its interpretation have introduced bias? |
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Unclear risk |
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Are there concerns that the target condition as defined by the reference standard does not match the question? |
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Low concern |
DOMAIN 4: Flow and timing |
Did all patients receive the same reference standard? |
Unclear |
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Were all patients included in the analysis? |
Yes |
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Could the patient flow have introduced bias? |
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Unclear risk |
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DOMAIN 5: Comparative |