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Table 2 Single- and two-gate interpretations

From: Use of test accuracy study design labels in NICE’s diagnostic guidance

Reference Text Variations in interpretation
Rutjes et al. [9] “(…). All patients pass through a single-gate: a single set of criteria for study admission, typically defined by the clinical presentation.”
“(…) We refer to this as a “two-gate design using healthy controls”. Two different sets of inclusion criteria (gates) are used: one for the diseased and another for the non-diseased participants.”
A single- and two-gate is defined by the number of eligibility criteria (sets).
DAR8 “The majority of included studies comply with a single-gate design, a single sample of individuals with unknown metastatic status was assessed by both the diagnostic test under scrutiny and the reference standard.” A single-gate study is defined by a single sample with (unknown) disease status and all participants receiving both reference standard and index test.
DAR20 “Single-gate: A study design in which only patients with the target condition are recruited.”
“(…), single-gate studies, that is, studies in which only patients with the target condition (suspected sepsis) were recruited.”
A single-gate study is defined by inclusion of only patients by (known) disease status.
Later, participants with the target condition are described as suspected individuals.
DAR27 “Single-gate study: Where a single sample of individuals is assessed by both the index test and reference standard.”
“Two-gate study: Studies which employ separate sampling schemes for diseased and non-diseased participants, with both groups being assessed by the index test.”
A single-gate is defined by both (a single set of) eligibility criteria and study flow (receiving both tests).
Two-gate study is defined by (two sets of) eligibility criteria, (known) disease status and study flow both groups receiving the index test.
DG33 “Single-gate study: Study design where participants’ disease status is unknown and the index test result is evaluated against the reference standard to confirm the diagnosis” A single-gate is defined by inclusion of participants by only (unknown) disease status and receiving both tests.
  1. The table shows variations in the interpretations of the single- and two-gate labels from included DG. The first row shows the citations from the original definition made by Rutjes et al. [9]
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