Development and Validation of a Chinese Version of the Readiness for Hospital Discharge Instrument After Initial Invasive Percutaneous Transhepatic Biliary Drainage: A Methodological Study.

Donanemab and lecanemab are amyloid‐targeting therapies (ATTs) approved by the US Food and Drug Administration that slow the progression of Alzheimer's disease (AD)., Currently, coverage of these medications is restricted under coverage with evidence development (CED) in the National Coverage Determination (NCD) issued by the Centers for Medicare & Medicaid Services (CMS) in April 2022. At the suggestion of CMS, Klein et al published a response in 2024, addressing each of the three questions posed by CMS in the CED with robust evidence for donanemab. Despite the strength of the evidence, CMS has not yet initiated reconsideration of the national coverage policy. New data available since the Klein et al report are summarized to provide further evidence relevant to CMS's questions. Phase 3 long‐term extension (LTE) and open‐label extension (OLE) data have been published for both donanemab and lecanemab, respectively., Clinical efficacy in these studies was assessed using the Clinical Demetia Rating (CDR) scale, including CDR‐Sum of Boxes (CDR‐SB) and CDR‐Global (CDR‐G). CDR evaluates impairment across cognitive and functional domains relevant and important to individuals living with AD. CDR‐SB is a continuous measure ranging from 0 to 18, with higher scores indicating greater impairment and is useful for detecting gradual changes over time. In contrast, CDR‐G is a categorical staging measure with values of 0 (normal), 0.5 (mild cognitive impairment/very mild impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). Accordingly, CDR‐SB quantifies the extent of change, whereas CDR‐G helps interpret that change in terms of clinically recognizable disease stage. For example, a change in CDR‐G from 0.5 to 1.0 indicates progression from mild cognitive impairment (MCI) to mild dementia due to AD, reflecting worsening in cognition and daily function., Because progression to the next disease stage on the CDR‐G scale represents a marked decline in cognition and daily function, slowing this progression is considered clinically meaningful. Further, slowing of disease progression by greater than 25% on the CDR‐SB scale has been recognized as clinically meaningful to clinicians and patients. In addition to extension efficacy data representing additional follow‐up time, here we also review new studies and evidence related to amyloid‐related imaging abnormalities (ARIA) risk and management., ,