4.1 Letter

Do we really need to calculate a minimal important difference for ALSFRS-R?: A letter in response to Clinically meaningful change: evaluation of the Rasch-built Overall Amyotrophic Lateral Sclerosis Disability Scale (ROADS) and the ALSFRS-R' published in Vol. 24(3-4), pp. 311-316

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Article Clinical Neurology

Clinically meaningful change: evaluation of the Rasch-built Overall Amyotrophic Lateral Sclerosis Disability Scale (ROADS) and the ALSFRS-R

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Summary: This study investigates the clinically meaningful change of ROADS and ALSFRS-R using a patient-defined approach. The study found that changes less than 5.81 points on the normed ROADS score or less than 3.24 points on the ALSFRS-R sum-score may not be clinically meaningful. It is important to understand the limitations of these scales in designing and interpreting ALS research studies.

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An old friend who has overstayed their welcome: the ALSFRS-R total score as primary endpoint for ALS clinical trials

Ruben P. A. van Eijk et al.

Summary: The study evaluated how multidimensionality affects the performance of the ALSFRS-R in clinical trials. Results suggest that ignoring the multidimensional structure may have negative consequences for ALS clinical trials. It is recommended to assess treatment benefit on a subscale level before concluding the overall effectiveness of a treatment.

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Summary: The minimal important change (MIC) is defined as a threshold for a minimal within-person change over time; estimation of MIC values should be conducted using appropriate methods, with current studies suggesting a reasonable range of 2-6 T-score points for PROMIS measures.

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Functional scales: Summary

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