Saad 2016.
Study characteristics | |||
Patient Sampling | Case‐control study; part of a prospective study evaluating clinical, topographic, tomographic, and biomechanical characteristics of people with keratoconus and keratoconus suspect at the Rothschild Foundation, Paris, France. The study included healthy people and people with keratoconus suspect. | ||
Patient characteristics and setting | 119 eyes of 176 people from the Department of Ophthalmology of the Rothschild Foundation were included and separated into 2 groups: normal and keratoconus suspect. The 2 groups were divided based on the results of the Nidek Corneal Navigator (NCN) automated corneal classification software in the OPD‐Scan (Nidek Co. Ltd., Gamagori, Japan).
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Index tests | Discriminant analysis, combining Placido (topography) and corneal wavefront data to detect early forms of keratoconus and to classify corneas as healthy, keratoconus suspect, or keratoconus. | ||
Target condition and reference standard(s) | The article did not mention who made the diagnosis of keratoconus or keratoconus suspect; however, all cases were separated in the 2 groups before the discriminant analysis. | ||
Flow and timing | It was unclear whether all participants received the same reference standard. All cases did receive the same index test, and all data were included in a 2 × 2 table. | ||
Comparative | Not applicable | ||
Notes | No funding source mentioned. | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
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? | Unclear | ||
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? | Unclear | ||
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? | Low risk | ||
DOMAIN 5: Comparative |