Study characteristics |
Patient Sampling |
Multicentre (Japan), retrospective, case‐control study which included 329 eyes (healthy controls and people with keratoconus). |
Patient characteristics and setting |
People with keratoconus were aged < 50 years, visited 1 of the facilities between January 2015 and December 2018, were diagnosed with keratoconus, Amsler‐Krumeich classification stage 1 (average K value < 48 D and corneal astigmatism < 5 D), had no ocular diseases other than keratoconus and refractive error, and had no history of ocular surgery.
Healthy subjects were people aged < 50 years who had undergone an ophthalmic screening.
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Index tests |
Multivariate logistic regression analysis to create an equation that predicts early keratoconus (keratometer keratoconus index) using auto‐keratometer parameters. |
Target condition and reference standard(s) |
Keratoconus diagnosis was based on corneal topography or tomography results (corneal steepening and asymmetric astigmatism, protrusion of the posterior cornea, and thinning of the cornea at the area of protrusion) and slit‐lamp findings. 2 corneal specialists classified the cases before inclusion. |
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 |
This research did not receive any specific grant from funding agencies in the public, commercial, or not‐for‐profit sectors. |
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? |
Yes |
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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? |
No |
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Could the conduct or interpretation of the index test have introduced bias? |
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High 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? |
Yes |
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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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Low 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? |
Yes |
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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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Low risk |
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DOMAIN 5: Comparative |