Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentary
Abstract Introduction Approval of the anti‐amyloid monoclonal antibodies has stimulated an important discussion of the value to be placed on the magnitude of slowing achieved by treatment compared to placebo. Methods The minimal clinically important difference (MCID) was reviewed in the context of o...
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| Format: | Article |
| Language: | English |
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Wiley
2023-07-01
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| Series: | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| Online Access: | https://doi.org/10.1002/trc2.12411 |
| _version_ | 1797648408416092160 |
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| author | Jeffrey Cummings |
| author_facet | Jeffrey Cummings |
| author_sort | Jeffrey Cummings |
| collection | DOAJ |
| description | Abstract Introduction Approval of the anti‐amyloid monoclonal antibodies has stimulated an important discussion of the value to be placed on the magnitude of slowing achieved by treatment compared to placebo. Methods The minimal clinically important difference (MCID) was reviewed in the context of other measures and analyses that provide perspective on the meaningfulness of treatment responses. Results TheMCID is a clinician‐anchored approach to making this determination. The MCID applies best to symptomatic therapies for which the drug–placebo difference remains constant. Disease‐modifying therapies produce a progressive divergence of drug and placebo trajectories; early in the course the MCID would not be achieved, later the MCID will be achieved, and with continuing therapy the MCID will be exceeded. Clinicians are not the only stakeholders involved in determining the value proposition of slowing disease progression. Patient‐reported outcomes and caregiver‐related measures offer important complementary insights. Analytic approaches also widen the perspective on the observed drug–placebo differences. Risk ratios, numbers needed to treat versus number needed to harm, time‐to‐event analyses, and predictive benefits based on biomarkers all add depth to the discussion. Discussion Multiple stakeholder perspectives are needed to determine the importance to be attributed to the therapeutic changes observed with monoclonal antibody therapies and other emerging treatments. |
| first_indexed | 2024-03-11T15:31:47Z |
| format | Article |
| id | doaj.art-0c9da176273b4d13bd775e6ff58ee8e5 |
| institution | Directory Open Access Journal |
| issn | 2352-8737 |
| language | English |
| last_indexed | 2024-03-11T15:31:47Z |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| spelling | doaj.art-0c9da176273b4d13bd775e6ff58ee8e52023-10-27T04:03:21ZengWileyAlzheimer’s & Dementia: Translational Research & Clinical Interventions2352-87372023-07-0193n/an/a10.1002/trc2.12411Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentaryJeffrey Cummings0Chambers‐Grundy Center for Transformative Neuroscience Department of Brain Health School of Integrated Health Sciences University of Nevada Las Vegas (UNLV) Las VegasNevadaUSAAbstract Introduction Approval of the anti‐amyloid monoclonal antibodies has stimulated an important discussion of the value to be placed on the magnitude of slowing achieved by treatment compared to placebo. Methods The minimal clinically important difference (MCID) was reviewed in the context of other measures and analyses that provide perspective on the meaningfulness of treatment responses. Results TheMCID is a clinician‐anchored approach to making this determination. The MCID applies best to symptomatic therapies for which the drug–placebo difference remains constant. Disease‐modifying therapies produce a progressive divergence of drug and placebo trajectories; early in the course the MCID would not be achieved, later the MCID will be achieved, and with continuing therapy the MCID will be exceeded. Clinicians are not the only stakeholders involved in determining the value proposition of slowing disease progression. Patient‐reported outcomes and caregiver‐related measures offer important complementary insights. Analytic approaches also widen the perspective on the observed drug–placebo differences. Risk ratios, numbers needed to treat versus number needed to harm, time‐to‐event analyses, and predictive benefits based on biomarkers all add depth to the discussion. Discussion Multiple stakeholder perspectives are needed to determine the importance to be attributed to the therapeutic changes observed with monoclonal antibody therapies and other emerging treatments.https://doi.org/10.1002/trc2.12411 |
| spellingShingle | Jeffrey Cummings Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentary Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| title | Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentary |
| title_full | Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentary |
| title_fullStr | Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentary |
| title_full_unstemmed | Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentary |
| title_short | Meaningful benefit and minimal clinically important difference (MCID) in Alzheimer's disease: Open peer commentary |
| title_sort | meaningful benefit and minimal clinically important difference mcid in alzheimer s disease open peer commentary |
| url | https://doi.org/10.1002/trc2.12411 |
| work_keys_str_mv | AT jeffreycummings meaningfulbenefitandminimalclinicallyimportantdifferencemcidinalzheimersdiseaseopenpeercommentary |