Table 1.
Item groups | Item list | Detailed items |
General characteristics | Diagnostic task | What is the target condition? |
Study objective | Is the study aiming at the development of a diagnostic method, evaluation of a diagnostic method or both? | |
Target population | What is the population targeted by the diagnostic test? | |
Methods | Data sources | Where and when potentially eligible participants were identified (setting, location and dates) |
Data split | Method for partitioning the evaluation set from the training data. To assess whether participants formed a consecutive, random or convenience series. | |
Test dataset eligibility criteria | On what basis potentially eligible participants were identified within the test dataset (such as symptoms, results from previous tests, inclusion in registry). | |
Results | Baseline characteristics | Baseline demographic and clinical characteristics of participants |
Diagnosis/non-diagnosis classification | Classification of the diagnosed and non-diagnosed patients within the test set. | |
Flow diagram | Flow of participants, using a diagram. | |
Severity | Distribution of severity of disease in those with the target condition. | |
Alternative diagnosis | Distribution of alternative diagnoses in those without the target condition. | |
Difference between reference test and ML test | Is there a time interval between index test and reference standard? | |
Applicability | Does the evaluation population correspond to the setting in which the diagnosis test will be applied? |
ML, machine learning.