Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study
The EARLYSTIM Study compared deep brain stimulation (DBS) with best medical treatment (BMT) over 2-years, showing a between-group difference of 8.0 from baseline in favor of DBS in health-related quality of life (HRQoL), measured with the PDQ-39 SI (summary index). This study obtained complementary...
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| creator | Martinez-Martin, Pablo Deuschl, Guenther Tonder, Lisa Schnitzler, Alfons Houeto, Jean-Luc Timmermann, Lars Rau, Joern Schade-Brittinger, Carmen Stoker, Valerie Vidailhet, Marie Krack, Paul |
| description | The EARLYSTIM Study compared deep brain stimulation (DBS) with best medical treatment (BMT) over 2-years, showing a between-group difference of 8.0 from baseline in favor of DBS in health-related quality of life (HRQoL), measured with the PDQ-39 SI (summary index). This study obtained complementary information about the importance of the change in HRQoL as measured by the PDQ-39, using anchor-based (Patient Global Impression of Change, PGIC) and distribution-based techniques (magnitude of change, effect size, thresholds, distribution of benefit) applied to the EARLYSTIM study data. Anchor-based techniques showed a difference follow-up-baseline for patients who reported "minimal improvement" of -5.8 [-9.9, -1.6] (mean [95%CI]) in the DBS group vs -2.9 [-9.0, 3.1] in the BMT group. As the vast majority (80.8%) of DBS patients reported "much or very much improvement", this difference was explored for the latter group and amounted to -8.7 for the DBS group and -6.5 in the BMT group. Distribution-based techniques that analyzed the relative change and treatment effect size showed a moderate benefit of the DBS on the HRQoL, whereas a slight worsening was observed in the BMT group. The change in the DBS group (-7.8) was higher than the MIC (Minimally Important Change) estimated value (-5.8 by the anchor; -6.3 by triangulation of thresholds), but not in the BMT (0.2 vs. -3.0 to -5.4, respectively). Almost 90% of the patients in the DBS group declared some improvement (58.3% and 56.7% beyond the estimated MIC), which was significantly different from the BMT group whose proportions were 32.0% and 30.3%, respectively. The number needed to treat to improve ≥1 MIC by DBS vs BMT was 3.8. Change in depression, disability and pain influenced the improvement of the DBS group. DBS improved HRQoL in a high proportion of patients to a significant and moderate degree, at 2 years follow-up. |
| doi_str_mv | 10.1371/journal.pone.0237498 |
| format | Article |
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This study obtained complementary information about the importance of the change in HRQoL as measured by the PDQ-39, using anchor-based (Patient Global Impression of Change, PGIC) and distribution-based techniques (magnitude of change, effect size, thresholds, distribution of benefit) applied to the EARLYSTIM study data. Anchor-based techniques showed a difference follow-up-baseline for patients who reported "minimal improvement" of -5.8 [-9.9, -1.6] (mean [95%CI]) in the DBS group vs -2.9 [-9.0, 3.1] in the BMT group. As the vast majority (80.8%) of DBS patients reported "much or very much improvement", this difference was explored for the latter group and amounted to -8.7 for the DBS group and -6.5 in the BMT group. Distribution-based techniques that analyzed the relative change and treatment effect size showed a moderate benefit of the DBS on the HRQoL, whereas a slight worsening was observed in the BMT group. The change in the DBS group (-7.8) was higher than the MIC (Minimally Important Change) estimated value (-5.8 by the anchor; -6.3 by triangulation of thresholds), but not in the BMT (0.2 vs. -3.0 to -5.4, respectively). Almost 90% of the patients in the DBS group declared some improvement (58.3% and 56.7% beyond the estimated MIC), which was significantly different from the BMT group whose proportions were 32.0% and 30.3%, respectively. The number needed to treat to improve ≥1 MIC by DBS vs BMT was 3.8. Change in depression, disability and pain influenced the improvement of the DBS group. DBS improved HRQoL in a high proportion of patients to a significant and moderate degree, at 2 years follow-up.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0237498</identifier><identifier>PMID: 32822437</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Activities of Daily Living ; Biology and Life Sciences ; Clinical trials ; Cohort Studies ; Deep Brain Stimulation ; Disease ; FDA approval ; Health aspects ; Health services ; Humans ; Intervention ; Levodopa - therapeutic use ; Life Sciences ; Medical treatment ; Medicine and Health Sciences ; Methods ; Middle Aged ; Movement disorders ; Neurodegenerative diseases ; Neurology ; Neurons and Cognition ; Pain ; Parkinson disease ; Parkinson Disease - drug therapy ; Parkinson Disease - pathology ; Parkinson Disease - psychology ; Parkinson Disease - therapy ; Parkinson's disease ; Parkinsons disease ; Patient outcomes ; Patients ; Physical Sciences ; Population ; Quality of Life ; Research and Analysis Methods ; Santé publique et épidémiologie ; Severity of Illness Index ; Social aspects ; Social Sciences ; Supervision ; Thresholds ; Treatment Outcome ; Triangulation</subject><ispartof>PloS one, 2020-08, Vol.15 (8), p.e0237498</ispartof><rights>COPYRIGHT 2020 Public Library of Science</rights><rights>2020 Martinez-Martin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 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This study obtained complementary information about the importance of the change in HRQoL as measured by the PDQ-39, using anchor-based (Patient Global Impression of Change, PGIC) and distribution-based techniques (magnitude of change, effect size, thresholds, distribution of benefit) applied to the EARLYSTIM study data. Anchor-based techniques showed a difference follow-up-baseline for patients who reported "minimal improvement" of -5.8 [-9.9, -1.6] (mean [95%CI]) in the DBS group vs -2.9 [-9.0, 3.1] in the BMT group. As the vast majority (80.8%) of DBS patients reported "much or very much improvement", this difference was explored for the latter group and amounted to -8.7 for the DBS group and -6.5 in the BMT group. Distribution-based techniques that analyzed the relative change and treatment effect size showed a moderate benefit of the DBS on the HRQoL, whereas a slight worsening was observed in the BMT group. The change in the DBS group (-7.8) was higher than the MIC (Minimally Important Change) estimated value (-5.8 by the anchor; -6.3 by triangulation of thresholds), but not in the BMT (0.2 vs. -3.0 to -5.4, respectively). Almost 90% of the patients in the DBS group declared some improvement (58.3% and 56.7% beyond the estimated MIC), which was significantly different from the BMT group whose proportions were 32.0% and 30.3%, respectively. The number needed to treat to improve ≥1 MIC by DBS vs BMT was 3.8. Change in depression, disability and pain influenced the improvement of the DBS group. DBS improved HRQoL in a high proportion of patients to a significant and moderate degree, at 2 years follow-up.</description><subject>Activities of Daily Living</subject><subject>Biology and Life Sciences</subject><subject>Clinical trials</subject><subject>Cohort Studies</subject><subject>Deep Brain Stimulation</subject><subject>Disease</subject><subject>FDA approval</subject><subject>Health aspects</subject><subject>Health services</subject><subject>Humans</subject><subject>Intervention</subject><subject>Levodopa - therapeutic use</subject><subject>Life Sciences</subject><subject>Medical treatment</subject><subject>Medicine and Health Sciences</subject><subject>Methods</subject><subject>Middle Aged</subject><subject>Movement disorders</subject><subject>Neurodegenerative diseases</subject><subject>Neurology</subject><subject>Neurons and Cognition</subject><subject>Pain</subject><subject>Parkinson disease</subject><subject>Parkinson Disease - drug therapy</subject><subject>Parkinson Disease - pathology</subject><subject>Parkinson Disease - psychology</subject><subject>Parkinson Disease - therapy</subject><subject>Parkinson's disease</subject><subject>Parkinsons disease</subject><subject>Patient outcomes</subject><subject>Patients</subject><subject>Physical Sciences</subject><subject>Population</subject><subject>Quality of Life</subject><subject>Research and Analysis Methods</subject><subject>Santé publique et épidémiologie</subject><subject>Severity of Illness Index</subject><subject>Social aspects</subject><subject>Social Sciences</subject><subject>Supervision</subject><subject>Thresholds</subject><subject>Treatment Outcome</subject><subject>Triangulation</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNk99v0zAQxyMEYmPwHyCIhATsocW_YicvSNU0WKWioXUg8WS58bl1SePOdib63-PQbmqnPaA8JDp_vt_zXe6y7DVGQ0wF_rR0nW9VM1y7FoaIUMGq8kl2jCtKBpwg-nTv-yh7EcISoYKWnD_PjigpCWFUHGd23Ebwaw9RReva3Jl8AaqJi4GHRkXQ-U2nGhs3_UljDeSui7VbQchtm39X_rdtg2s_hFzbACpAbrxb5XEB-fnoavJrej3-lk9jpzcvs2dGNQFe7d4n2Y8v59dnF4PJ5dfx2WgyqAXhcQCkBEoLQQEhzmdMoRpjk-rT3FQUlbyqtNGmQFhQokolqmKGiVa6UHymRUlPsrdb33Xjgtx1KchULscME14kYrwltFNLufZ2pfxGOmXlv4Dzc6l8tHUDkiutKsQxRswwUoqUnlXMADdEUMOr5PV5l62brUDX0EavmgPTw5PWLuTc3UrBGCEFTganW4PFA9nFaCL7GCIVQ5yw2579uEvm3U0HIcqVDTU0jWrBddsaGaIE9fd69wB9vBM7aq5SsbY1Lt2x7k3liFOKCyGoSNTwESo9Gla2TuNnbIofCE4PBImJ8CfOVReCHE-v_p-9_HnIvt9jt3MaXNP1kxsOQbYFa-9C8GDuO4uR7Lfnrhuy3x65254ke7P_M-9Fd-tC_wJiYxIo</recordid><startdate>20200821</startdate><enddate>20200821</enddate><creator>Martinez-Martin, Pablo</creator><creator>Deuschl, Guenther</creator><creator>Tonder, Lisa</creator><creator>Schnitzler, Alfons</creator><creator>Houeto, Jean-Luc</creator><creator>Timmermann, Lars</creator><creator>Rau, Joern</creator><creator>Schade-Brittinger, Carmen</creator><creator>Stoker, Valerie</creator><creator>Vidailhet, Marie</creator><creator>Krack, Paul</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-2409-9143</orcidid></search><sort><creationdate>20200821</creationdate><title>Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study</title><author>Martinez-Martin, Pablo ; Deuschl, Guenther ; Tonder, Lisa ; Schnitzler, Alfons ; Houeto, Jean-Luc ; Timmermann, Lars ; Rau, Joern ; Schade-Brittinger, Carmen ; Stoker, Valerie ; Vidailhet, Marie ; Krack, Paul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c726t-e28e33573e0066b4a0c11f023d6f9308699dfdf501732a8a795b12dad5a6bd783</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Activities of Daily Living</topic><topic>Biology and Life Sciences</topic><topic>Clinical trials</topic><topic>Cohort Studies</topic><topic>Deep Brain Stimulation</topic><topic>Disease</topic><topic>FDA approval</topic><topic>Health aspects</topic><topic>Health services</topic><topic>Humans</topic><topic>Intervention</topic><topic>Levodopa - 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Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database (Proquest) (PQ_SDU_P3)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><collection>Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Martinez-Martin, Pablo</au><au>Deuschl, Guenther</au><au>Tonder, Lisa</au><au>Schnitzler, Alfons</au><au>Houeto, Jean-Luc</au><au>Timmermann, Lars</au><au>Rau, Joern</au><au>Schade-Brittinger, Carmen</au><au>Stoker, Valerie</au><au>Vidailhet, Marie</au><au>Krack, Paul</au><au>Sgambato, Véronique</au><aucorp>EARLYSTIM Study Group</aucorp><aucorp>on behalf of the EARLYSTIM Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2020-08-21</date><risdate>2020</risdate><volume>15</volume><issue>8</issue><spage>e0237498</spage><pages>e0237498-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>The EARLYSTIM Study compared deep brain stimulation (DBS) with best medical treatment (BMT) over 2-years, showing a between-group difference of 8.0 from baseline in favor of DBS in health-related quality of life (HRQoL), measured with the PDQ-39 SI (summary index). This study obtained complementary information about the importance of the change in HRQoL as measured by the PDQ-39, using anchor-based (Patient Global Impression of Change, PGIC) and distribution-based techniques (magnitude of change, effect size, thresholds, distribution of benefit) applied to the EARLYSTIM study data. Anchor-based techniques showed a difference follow-up-baseline for patients who reported "minimal improvement" of -5.8 [-9.9, -1.6] (mean [95%CI]) in the DBS group vs -2.9 [-9.0, 3.1] in the BMT group. As the vast majority (80.8%) of DBS patients reported "much or very much improvement", this difference was explored for the latter group and amounted to -8.7 for the DBS group and -6.5 in the BMT group. Distribution-based techniques that analyzed the relative change and treatment effect size showed a moderate benefit of the DBS on the HRQoL, whereas a slight worsening was observed in the BMT group. The change in the DBS group (-7.8) was higher than the MIC (Minimally Important Change) estimated value (-5.8 by the anchor; -6.3 by triangulation of thresholds), but not in the BMT (0.2 vs. -3.0 to -5.4, respectively). Almost 90% of the patients in the DBS group declared some improvement (58.3% and 56.7% beyond the estimated MIC), which was significantly different from the BMT group whose proportions were 32.0% and 30.3%, respectively. The number needed to treat to improve ≥1 MIC by DBS vs BMT was 3.8. Change in depression, disability and pain influenced the improvement of the DBS group. DBS improved HRQoL in a high proportion of patients to a significant and moderate degree, at 2 years follow-up.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>32822437</pmid><doi>10.1371/journal.pone.0237498</doi><tpages>e0237498</tpages><orcidid>https://orcid.org/0000-0002-2409-9143</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2020-08, Vol.15 (8), p.e0237498 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2436141265 |
| source | Public Library of Science (PLoS) Journals Open Access; MEDLINE; PubMed Central; Directory of Open Access Journals; Free Full-Text Journals in Chemistry; EZB Electronic Journals Library |
| subjects | Activities of Daily Living Biology and Life Sciences Clinical trials Cohort Studies Deep Brain Stimulation Disease FDA approval Health aspects Health services Humans Intervention Levodopa - therapeutic use Life Sciences Medical treatment Medicine and Health Sciences Methods Middle Aged Movement disorders Neurodegenerative diseases Neurology Neurons and Cognition Pain Parkinson disease Parkinson Disease - drug therapy Parkinson Disease - pathology Parkinson Disease - psychology Parkinson Disease - therapy Parkinson's disease Parkinsons disease Patient outcomes Patients Physical Sciences Population Quality of Life Research and Analysis Methods Santé publique et épidémiologie Severity of Illness Index Social aspects Social Sciences Supervision Thresholds Treatment Outcome Triangulation |
| title | Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study |
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