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. |