Placebo-associated improvements in motor function: Comparison of subjective and objective sections of the UPDRS in early Parkinson's disease
Identifieur interne :
000526 ( PascalFrancis/Curation );
précédent :
000525;
suivant :
000527
Placebo-associated improvements in motor function: Comparison of subjective and objective sections of the UPDRS in early Parkinson's disease
Auteurs : Christopher G. Goetz [
États-Unis] ;
Sue Leurgans [
États-Unis] ;
Rema Raman [
États-Unis]
Source :
-
Movement disorders [ 0885-3185 ] ; 2002.
RBID : Pascal:02-0309306
Descripteurs français
- Pascal (Inist)
- Parkinson maladie,
Précoce,
Tocophérol,
Sélégiline,
Antiparkinsonien,
Placebo,
Motricité,
Chimiothérapie,
Traitement,
Homme,
Echelle mesure.
- Wicri :
English descriptors
- KwdEn :
- Antiparkinson agent,
Chemotherapy,
Early,
Human,
Measurement scale,
Motricity,
Parkinson disease,
Placebo,
Selegiline,
Tocopherol,
Treatment.
Abstract
The Unified Parkinson's Disease Rating Scale (UPDRS) is primarily composed of an investigator-derived objective rating of motor function and a patient-derived assessment of activities of daily living (ADL). Using a stringent definition of placebo effect, we examined the frequency, temporal development, and stability of improvements during placebo treatment over 6 months in a large placebo-controlled trial of deprenyl and tocopherol in early Parkinson's disease (DATATOP). One hundred ninety-nine subjects received placebo treatment in the randomized, multicenter, placebo-controlled DATATOP study. We compared the baseline UPDRS motor section scores with follow-up scores at 4, 13, and 26 weeks. Placebo-associated improvement was defined as an improvement over baseline score in motor UPDRS of at least 50% or a change in at least two motor items at any one visit by two or more points, Seventeen percent of the 185 subjects who qualified for analysis met the placebo response criteria. The group prevalence of response was steady (7% to 10%) at any one visit without a marked predominance of an early study effect. Older subjects with more motor impairment at baseline were most likely to show a placebo-associated improvement. ADL scores were low throughout the study, and ADL improvements did not identify the subjects with objectively defined placebo-associated improvement. Prominent improvements in investigator-derived objective measures of Parkinson's disease motor impairment occur during clinical trials. including one that was not aimed at showing improved short-term efficacy. Although the notion of placebo effect often implies patient-based perceptions, we found subjective changes to be infrequent in placebo-treated patients, suggesting that either: (1) the placebo effect was rater-driven; (2) the ADL questionnaire is insensitive to transient but objectively demonstrable motor changes; or (3) that the objective changes, albeit major, are within the realm of natural variation in the UPDRS motor scale from visit to visit.
pA |
A01 | 01 | 1 | | @0 0885-3185 |
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A03 | | 1 | | @0 Mov. disord. |
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A08 | 01 | 1 | ENG | @1 Placebo-associated improvements in motor function: Comparison of subjective and objective sections of the UPDRS in early Parkinson's disease |
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A11 | 01 | 1 | | @1 GOETZ (Christopher G.) |
---|
A11 | 02 | 1 | | @1 LEURGANS (Sue) |
---|
A11 | 03 | 1 | | @1 RAMAN (Rema) |
---|
A14 | 01 | | | @1 Department of Neurological Sciences, Rush University, Rush Presbyterian St. Luke's Medical Center @2 Chicago, Illinois @3 USA @Z 1 aut. @Z 2 aut. |
---|
A14 | 02 | | | @1 Department of Preventive Medicine, Rush University, Rush Presbyterian St. Luke's Medical Center @2 Chicago, Illinois @3 USA @Z 2 aut. @Z 3 aut. |
---|
A17 | 01 | 1 | | @1 Parkinson Study Group @3 INC |
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A20 | | | | @1 283-288 |
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A21 | | | | @1 2002 |
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A23 | 01 | | | @0 ENG |
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A43 | 01 | | | @1 INIST @2 20953 @5 354000100907450080 |
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A44 | | | | @0 0000 @1 © 2002 INIST-CNRS. All rights reserved. |
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A47 | 01 | 1 | | @0 02-0309306 |
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A60 | | | | @1 P @2 C |
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A61 | | | | @0 A |
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A64 | 01 | 1 | | @0 Movement disorders |
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A66 | 01 | | | @0 USA |
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C01 | 01 | | ENG | @0 The Unified Parkinson's Disease Rating Scale (UPDRS) is primarily composed of an investigator-derived objective rating of motor function and a patient-derived assessment of activities of daily living (ADL). Using a stringent definition of placebo effect, we examined the frequency, temporal development, and stability of improvements during placebo treatment over 6 months in a large placebo-controlled trial of deprenyl and tocopherol in early Parkinson's disease (DATATOP). One hundred ninety-nine subjects received placebo treatment in the randomized, multicenter, placebo-controlled DATATOP study. We compared the baseline UPDRS motor section scores with follow-up scores at 4, 13, and 26 weeks. Placebo-associated improvement was defined as an improvement over baseline score in motor UPDRS of at least 50% or a change in at least two motor items at any one visit by two or more points, Seventeen percent of the 185 subjects who qualified for analysis met the placebo response criteria. The group prevalence of response was steady (7% to 10%) at any one visit without a marked predominance of an early study effect. Older subjects with more motor impairment at baseline were most likely to show a placebo-associated improvement. ADL scores were low throughout the study, and ADL improvements did not identify the subjects with objectively defined placebo-associated improvement. Prominent improvements in investigator-derived objective measures of Parkinson's disease motor impairment occur during clinical trials. including one that was not aimed at showing improved short-term efficacy. Although the notion of placebo effect often implies patient-based perceptions, we found subjective changes to be infrequent in placebo-treated patients, suggesting that either: (1) the placebo effect was rater-driven; (2) the ADL questionnaire is insensitive to transient but objectively demonstrable motor changes; or (3) that the objective changes, albeit major, are within the realm of natural variation in the UPDRS motor scale from visit to visit. |
---|
C02 | 01 | X | | @0 002B02B06 |
---|
C02 | 02 | X | | @0 002B17G |
---|
C03 | 01 | X | FRE | @0 Parkinson maladie @5 01 |
---|
C03 | 01 | X | ENG | @0 Parkinson disease @5 01 |
---|
C03 | 01 | X | SPA | @0 Parkinson enfermedad @5 01 |
---|
C03 | 02 | X | FRE | @0 Précoce @5 02 |
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C03 | 02 | X | ENG | @0 Early @5 02 |
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C03 | 02 | X | SPA | @0 Precoz @5 02 |
---|
C03 | 03 | X | FRE | @0 Tocophérol @5 04 |
---|
C03 | 03 | X | ENG | @0 Tocopherol @5 04 |
---|
C03 | 03 | X | SPA | @0 Tocoferol @5 04 |
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C03 | 04 | X | FRE | @0 Sélégiline @2 NK @2 FR @5 07 |
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C03 | 04 | X | ENG | @0 Selegiline @2 NK @2 FR @5 07 |
---|
C03 | 04 | X | SPA | @0 Selegilina @2 NK @2 FR @5 07 |
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C03 | 05 | X | FRE | @0 Antiparkinsonien @5 08 |
---|
C03 | 05 | X | ENG | @0 Antiparkinson agent @5 08 |
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C03 | 05 | X | SPA | @0 Antiparkinsoniano @5 08 |
---|
C03 | 06 | X | FRE | @0 Placebo @5 10 |
---|
C03 | 06 | X | ENG | @0 Placebo @5 10 |
---|
C03 | 06 | X | SPA | @0 Placebo @5 10 |
---|
C03 | 07 | X | FRE | @0 Motricité @5 13 |
---|
C03 | 07 | X | ENG | @0 Motricity @5 13 |
---|
C03 | 07 | X | SPA | @0 Motricidad @5 13 |
---|
C03 | 08 | X | FRE | @0 Chimiothérapie @5 16 |
---|
C03 | 08 | X | ENG | @0 Chemotherapy @5 16 |
---|
C03 | 08 | X | SPA | @0 Quimioterapia @5 16 |
---|
C03 | 09 | X | FRE | @0 Traitement @5 17 |
---|
C03 | 09 | X | ENG | @0 Treatment @5 17 |
---|
C03 | 09 | X | SPA | @0 Tratamiento @5 17 |
---|
C03 | 10 | X | FRE | @0 Homme @5 20 |
---|
C03 | 10 | X | ENG | @0 Human @5 20 |
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C03 | 10 | X | SPA | @0 Hombre @5 20 |
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C03 | 11 | X | FRE | @0 Echelle mesure @5 23 |
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C03 | 11 | X | ENG | @0 Measurement scale @5 23 |
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C03 | 11 | X | SPA | @0 Escala medida @5 23 |
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C07 | 01 | X | FRE | @0 Système nerveux pathologie @5 37 |
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C07 | 01 | X | ENG | @0 Nervous system diseases @5 37 |
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C07 | 01 | X | SPA | @0 Sistema nervioso patología @5 37 |
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C07 | 02 | X | FRE | @0 Système nerveux central pathologie @5 38 |
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C07 | 02 | X | ENG | @0 Central nervous system disease @5 38 |
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C07 | 02 | X | SPA | @0 Sistema nervosio central patología @5 38 |
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C07 | 03 | X | FRE | @0 Encéphale pathologie @5 39 |
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C07 | 03 | X | ENG | @0 Cerebral disorder @5 39 |
---|
C07 | 03 | X | SPA | @0 Encéfalo patología @5 39 |
---|
C07 | 04 | X | FRE | @0 Extrapyramidal syndrome @5 40 |
---|
C07 | 04 | X | ENG | @0 Extrapyramidal syndrome @5 40 |
---|
C07 | 04 | X | SPA | @0 Extrapiramidal síndrome @5 40 |
---|
C07 | 05 | X | FRE | @0 Maladie dégénérative @5 41 |
---|
C07 | 05 | X | ENG | @0 Degenerative disease @5 41 |
---|
C07 | 05 | X | SPA | @0 Enfermedad degenerativa @5 41 |
---|
N21 | | | | @1 175 |
---|
N82 | | | | @1 PSI |
---|
|
pR |
A30 | 01 | 1 | ENG | @1 American Neurological Association @3 Boston, Massachusetts USA @4 2000-10 |
---|
|
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Le document en format XML
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<front><div type="abstract" xml:lang="en">The Unified Parkinson's Disease Rating Scale (UPDRS) is primarily composed of an investigator-derived objective rating of motor function and a patient-derived assessment of activities of daily living (ADL). Using a stringent definition of placebo effect, we examined the frequency, temporal development, and stability of improvements during placebo treatment over 6 months in a large placebo-controlled trial of deprenyl and tocopherol in early Parkinson's disease (DATATOP). One hundred ninety-nine subjects received placebo treatment in the randomized, multicenter, placebo-controlled DATATOP study. We compared the baseline UPDRS motor section scores with follow-up scores at 4, 13, and 26 weeks. Placebo-associated improvement was defined as an improvement over baseline score in motor UPDRS of at least 50% or a change in at least two motor items at any one visit by two or more points, Seventeen percent of the 185 subjects who qualified for analysis met the placebo response criteria. The group prevalence of response was steady (7% to 10%) at any one visit without a marked predominance of an early study effect. Older subjects with more motor impairment at baseline were most likely to show a placebo-associated improvement. ADL scores were low throughout the study, and ADL improvements did not identify the subjects with objectively defined placebo-associated improvement. Prominent improvements in investigator-derived objective measures of Parkinson's disease motor impairment occur during clinical trials. including one that was not aimed at showing improved short-term efficacy. Although the notion of placebo effect often implies patient-based perceptions, we found subjective changes to be infrequent in placebo-treated patients, suggesting that either: (1) the placebo effect was rater-driven; (2) the ADL questionnaire is insensitive to transient but objectively demonstrable motor changes; or (3) that the objective changes, albeit major, are within the realm of natural variation in the UPDRS motor scale from visit to visit.</div>
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<fC01 i1="01" l="ENG"><s0>The Unified Parkinson's Disease Rating Scale (UPDRS) is primarily composed of an investigator-derived objective rating of motor function and a patient-derived assessment of activities of daily living (ADL). Using a stringent definition of placebo effect, we examined the frequency, temporal development, and stability of improvements during placebo treatment over 6 months in a large placebo-controlled trial of deprenyl and tocopherol in early Parkinson's disease (DATATOP). One hundred ninety-nine subjects received placebo treatment in the randomized, multicenter, placebo-controlled DATATOP study. We compared the baseline UPDRS motor section scores with follow-up scores at 4, 13, and 26 weeks. Placebo-associated improvement was defined as an improvement over baseline score in motor UPDRS of at least 50% or a change in at least two motor items at any one visit by two or more points, Seventeen percent of the 185 subjects who qualified for analysis met the placebo response criteria. The group prevalence of response was steady (7% to 10%) at any one visit without a marked predominance of an early study effect. Older subjects with more motor impairment at baseline were most likely to show a placebo-associated improvement. ADL scores were low throughout the study, and ADL improvements did not identify the subjects with objectively defined placebo-associated improvement. Prominent improvements in investigator-derived objective measures of Parkinson's disease motor impairment occur during clinical trials. including one that was not aimed at showing improved short-term efficacy. Although the notion of placebo effect often implies patient-based perceptions, we found subjective changes to be infrequent in placebo-treated patients, suggesting that either: (1) the placebo effect was rater-driven; (2) the ADL questionnaire is insensitive to transient but objectively demonstrable motor changes; or (3) that the objective changes, albeit major, are within the realm of natural variation in the UPDRS motor scale from visit to visit.</s0>
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<s5>16</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Quimioterapia</s0>
<s5>16</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Traitement</s0>
<s5>17</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Treatment</s0>
<s5>17</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Homme</s0>
<s5>20</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Human</s0>
<s5>20</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Hombre</s0>
<s5>20</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Echelle mesure</s0>
<s5>23</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Measurement scale</s0>
<s5>23</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Escala medida</s0>
<s5>23</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Central nervous system disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Encéphale pathologie</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Cerebral disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Encéfalo patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Extrapyramidal syndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Maladie dégénérative</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Degenerative disease</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>41</s5>
</fC07>
<fN21><s1>175</s1>
</fN21>
<fN82><s1>PSI</s1>
</fN82>
</pA>
<pR><fA30 i1="01" i2="1" l="ENG"><s1>American Neurological Association</s1>
<s3>Boston, Massachusetts USA</s3>
<s4>2000-10</s4>
</fA30>
</pR>
</standard>
</inist>
</record>
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