MovDisordV3, Main, Exploration, bibRecord, 001710

Determination of minimal clinically important change in early and advanced Parkinson's disease

Identifieur interne : 001710 ( Main/Exploration ); précédent : 001709; suivant : 001711

Determination of minimal clinically important change in early and advanced Parkinson's disease

Auteurs : Robert A. Hauser [États-Unis] ; Peggy Auinger [États-Unis]

Source :

Movement Disorders [ 0885-3185 ] ; 2011-04.

RBID : ISTEX:6AD41568559AA8DC0476C834E96F42BC72AE4B3F

Descripteurs français

Pascal (Inist)
- Essai clinique, Maladie de Parkinson, Pathologie du système nerveux, Stade avancé, Traitement.

English descriptors

KwdEn :
- Advanced stage, Antiparkinson Agents (therapeutic use), Clinical trial, Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Indans (therapeutic use), Levodopa, Male, Nervous system diseases, Neuroprotective Agents (therapeutic use), Parkinson Disease (classification), Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Placebo Effect, ROC Curve, Severity of Illness Index, Time Factors, Treatment, Treatment Outcome, clinical global impression, clinical trial, minimal clinically important change, treatment.
MESH :
- chemical , therapeutic use : Antiparkinson Agents, Indans, Neuroprotective Agents.
- classification : Parkinson Disease.
- drug therapy : Parkinson Disease.
- Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Levodopa, Male, Placebo Effect, ROC Curve, Severity of Illness Index, Time Factors, Treatment Outcome.

Abstract

Two common primary efficacy outcome measures in Parkinson's disease (PD) are change in Unified Parkinson's Disease Rating Scale (UPDRS) scores in early PD and change in “off” time in patients with motor fluctuations. Defining the minimal clinically important change (MCIC) in these outcome measures is important to interpret the clinical relevance of changes observed in clinical trials and other situations. We analyzed data from 2 multicenter, placebo‐controlled, randomized clinical trials of rasagiline; TEMPO studied 404 early PD subjects, and PRESTO studied 472 levodopa‐treated subjects with motor fluctuations. An anchor‐based approach using clinical global impression of improvement (CGI‐I) was used to determine MCIC for UPDRS scores and daily “off” time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI‐I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I–III) in early PD was determined to be −3.5 points based on mean scores and −3.0 points based on ROC curves. In addition, we found an MCIC for reduction in “off” time of 1.0 hours as defined by mean reduction in “off” time in active treated subjects self‐rated as minimally improved on CGI‐I minus mean reduction in “off” time in placebo‐treated subjects self‐rated as unchanged (1.9–0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies. © 2011 Movement Disorder Society

Url:

https://api.istex.fr/document/6AD41568559AA8DC0476C834E96F42BC72AE4B3F/fulltext/pdf

DOI: 10.1002/mds.23638

Affiliations:

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<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
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<front><div type="abstract" xml:lang="en">Two common primary efficacy outcome measures in Parkinson's disease (PD) are change in Unified Parkinson's Disease Rating Scale (UPDRS) scores in early PD and change in “off” time in patients with motor fluctuations. Defining the minimal clinically important change (MCIC) in these outcome measures is important to interpret the clinical relevance of changes observed in clinical trials and other situations. We analyzed data from 2 multicenter, placebo‐controlled, randomized clinical trials of rasagiline; TEMPO studied 404 early PD subjects, and PRESTO studied 472 levodopa‐treated subjects with motor fluctuations. An anchor‐based approach using clinical global impression of improvement (CGI‐I) was used to determine MCIC for UPDRS scores and daily “off” time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI‐I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I–III) in early PD was determined to be −3.5 points based on mean scores and −3.0 points based on ROC curves. In addition, we found an MCIC for reduction in “off” time of 1.0 hours as defined by mean reduction in “off” time in active treated subjects self‐rated as minimally improved on CGI‐I minus mean reduction in “off” time in placebo‐treated subjects self‐rated as unchanged (1.9–0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies. © 2011 Movement Disorder Society</div>
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Movement Disorders (revue)

Determination of minimal clinically important change in early and advanced Parkinson's disease

Determination of minimal clinically important change in early and advanced Parkinson's disease

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

	Movement Disorders (revue)
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