Table 1.
Anchor-based Approaches | Target Measures |
➣ Mean Change Mean change in NIS/NIS-LL scores for patients who did not exhibit meaningful worsening on the anchor ➣ Linear Regression Linear regression models with change in NIS/NIS-LL scores as the outcome and change in the anchor (LLF/PND) as the predictor ➣ Receiver Operating Characteristic Curve Receiver operating characteristic curves to identify the optimal cut-off point on NIS/NIS-LL scores for classifying patients showing meaningful worsening or not based on the anchor measure |
Anchor: Polyneuropathy Disability (PND) score • NIS Total • NIS Sensation • NIS-LL Sensation Anchor: Lower Limb Function (LLF) test • NIS-LL Total • NIS-LL Muscle Weakness |
Distribution-based Approaches | Target Measures |
➣ Effect Size Group difference or change over time relative to the standard deviation at baseline ➣ Standard Error of Measurement Measurement error of a scale based on the standard deviation of baseline scores and the scale’s intra-rater reliability ➣ Standardized Response Mean Group difference or change over time relative to the standard deviation of change scores |
• All NIS and NIS-LL total and subscales |
Abbreviations: NIS Neuropathy Impairment Score, NIS-LL Neuropathy Impairment Score – Lower Limbs