Table 1 Levels of diagnostic evidence of studies using a diagnostic device to determine viscoelastic joint properties or spasticity with a robotic device
Level 0 | Including less than ten participants |
Level I | Reporting range of values of test results in patients and/or healthy controls |
Level II | Correlating the test results with a reference test, or analyzing change over time, or comparing test results of patients and controls with descriptive statistics and significance testing |
Level III | Reporting statistical values of diagnostic accuracy, such as sensitivity or specificity, either comparing confirmed patients with reference test and controls (e.g. under ideal conditions, according to Phase II of Sackett and Haynes) or distinguishing within a suspected patient population (e.g. more realistic clinical setting, according to Phase III of Sackett and Haynes |
Level IV | Evaluating the clinical consequences of using the device by evaluating the clinical added value of the test results in patients who were measured with the device |