Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints
Background Clinical management of persons with disorders of consciousness (DoC) is dedicated largely to optimizing recovery. However, selecting a measure to evaluate the extent of recovery is challenging because few measures are designed to precisely assess the full range of potential outcomes, from...
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| Veröffentlicht in: | Neurocritical care 2024-10, Vol.41 (2), p.357-368 |
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| creator | Bodien, Yelena G. LaRovere, Kerri Kondziella, Daniel Taran, Shaurya Estraneo, Anna Shutter, Lori |
| description | Background
Clinical management of persons with disorders of consciousness (DoC) is dedicated largely to optimizing recovery. However, selecting a measure to evaluate the extent of recovery is challenging because few measures are designed to precisely assess the full range of potential outcomes, from prolonged DoC to return of preinjury functioning. Measures that are designed specifically to assess persons with DoC are often performance-based and only validated for in-person use. Moreover, there are no published recommendations addressing which outcome measures should be used to evaluate DoC recovery. The resulting inconsistency in the measures selected by individual investigators to assess outcome prevents comparison of results across DoC studies. The National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs) is an amalgamation of standardized variables and tools that are recommended for use in studies of neurologic diseases and injuries. The Neurocritical Care Society Curing Coma Campaign launched an initiative to develop CDEs specifically for DoC and invited our group to recommend CDE outcomes and endpoints for persons with DoCs.
Methods
The Curing Coma Campaign Outcomes and Endpoints CDE Workgroup, consisting of experts in adult and pediatric neurocritical care, neurology, and neuroscience, used a previously established five-step process to identify and select candidate CDEs: (1) review of existing NINDS CDEs, (2) nomination and systematic vetting of new CDEs, (3) CDE classification, (4) iterative review and approval of panel recommendations, and (5) development of case report forms.
Results
Among hundreds of existing NINDS outcome and endpoint CDE measures, we identified 20 for adults and 18 for children that can be used to assess the full range of recovery from coma. We also proposed 14 new outcome and endpoint CDE measures for adults and 5 for children.
Conclusions
The DoC outcome and endpoint CDEs are a starting point in the broader effort to standardize outcome evaluation of persons with DoC. The ultimate goal is to harmonize DoC studies and allow for more precise assessment of outcomes after severe brain injury or illness. An iterative approach is required to modify and adjust these outcome and endpoint CDEs as new evidence emerges. |
| doi_str_mv | 10.1007/s12028-024-02068-1 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3093172666</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3101021247</sourcerecordid><originalsourceid>FETCH-LOGICAL-c256t-1f077971af8eeee761af663523f81eb418849024f823bc45910dbd52b7f7fe723</originalsourceid><addsrcrecordid>eNp9UV1rFTEQDWKx9eof8EECvviyNpPsJru-ye21FgoFUXwM-zGpW-8m18wu0n_T39Jf1qm3KvjQQMjAnHPmTI4Qr0C9A6XcMYFWui6ULvkqWxfwRBxBVdlCNRae3tclFLYx5lA8J7pSSrvGVc_EoWmgNMZVR-LXOk1TivKknVu52eKEcSYZUpYnI6U8YCaZglynSP2YFopI9F5-xp5pGId2HrkjQ06TnL-j_JbyjzFeytOclp1k3YtlZiiSbOMgb282cdilkUe8EAeh3RK-fHhX4uvHzZf1p-L84vRs_eG86HVl5wKCcuwZ2lAjH2e5stZU2oQasCuhrsuGPyDU2nR9WTWghm6odOeCC-i0WYm3e91dTj8XpNlPI_W43bYReR1vVGPAacuiK_HmP-hVWnJkd96AAqVBl45Reo_qcyLKGPwuj1Obrz0ofx-L38fi2ZX_HYsHJr1-kF66CYe_lD85MMDsAcSteIn53-xHZO8Ar_WY4Q</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3101021247</pqid></control><display><type>article</type><title>Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Bodien, Yelena G. ; LaRovere, Kerri ; Kondziella, Daniel ; Taran, Shaurya ; Estraneo, Anna ; Shutter, Lori</creator><creatorcontrib>Bodien, Yelena G. ; LaRovere, Kerri ; Kondziella, Daniel ; Taran, Shaurya ; Estraneo, Anna ; Shutter, Lori ; Curing Coma Campaign, its Contributing Members ; the Curing Coma Campaign, its Contributing Members</creatorcontrib><description>Background
Clinical management of persons with disorders of consciousness (DoC) is dedicated largely to optimizing recovery. However, selecting a measure to evaluate the extent of recovery is challenging because few measures are designed to precisely assess the full range of potential outcomes, from prolonged DoC to return of preinjury functioning. Measures that are designed specifically to assess persons with DoC are often performance-based and only validated for in-person use. Moreover, there are no published recommendations addressing which outcome measures should be used to evaluate DoC recovery. The resulting inconsistency in the measures selected by individual investigators to assess outcome prevents comparison of results across DoC studies. The National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs) is an amalgamation of standardized variables and tools that are recommended for use in studies of neurologic diseases and injuries. The Neurocritical Care Society Curing Coma Campaign launched an initiative to develop CDEs specifically for DoC and invited our group to recommend CDE outcomes and endpoints for persons with DoCs.
Methods
The Curing Coma Campaign Outcomes and Endpoints CDE Workgroup, consisting of experts in adult and pediatric neurocritical care, neurology, and neuroscience, used a previously established five-step process to identify and select candidate CDEs: (1) review of existing NINDS CDEs, (2) nomination and systematic vetting of new CDEs, (3) CDE classification, (4) iterative review and approval of panel recommendations, and (5) development of case report forms.
Results
Among hundreds of existing NINDS outcome and endpoint CDE measures, we identified 20 for adults and 18 for children that can be used to assess the full range of recovery from coma. We also proposed 14 new outcome and endpoint CDE measures for adults and 5 for children.
Conclusions
The DoC outcome and endpoint CDEs are a starting point in the broader effort to standardize outcome evaluation of persons with DoC. The ultimate goal is to harmonize DoC studies and allow for more precise assessment of outcomes after severe brain injury or illness. An iterative approach is required to modify and adjust these outcome and endpoint CDEs as new evidence emerges.</description><identifier>ISSN: 1541-6933</identifier><identifier>ISSN: 1556-0961</identifier><identifier>EISSN: 1556-0961</identifier><identifier>DOI: 10.1007/s12028-024-02068-1</identifier><identifier>PMID: 39143375</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Clinical outcomes ; Coma ; Common Data Elements ; Common Data Elements for Disorders of Consciousness ; Consciousness ; Consciousness Disorders - diagnosis ; Consciousness Disorders - therapy ; Critical Care Medicine ; Data collection ; Humans ; Intensive ; Internal Medicine ; Medicine ; Medicine & Public Health ; National Institute of Neurological Disorders and Stroke (U.S.) - standards ; Neurology ; Neuropsychology ; Neurosurgery ; Outcome Assessment, Health Care - standards ; Patients ; Pediatrics ; Quality of life ; Stroke ; Traumatic brain injury</subject><ispartof>Neurocritical care, 2024-10, Vol.41 (2), p.357-368</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society 2024. corrected publication 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2024. Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c256t-1f077971af8eeee761af663523f81eb418849024f823bc45910dbd52b7f7fe723</cites><orcidid>0000-0003-4858-2903</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12028-024-02068-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12028-024-02068-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,777,781,27905,27906,41469,42538,51300</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39143375$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bodien, Yelena G.</creatorcontrib><creatorcontrib>LaRovere, Kerri</creatorcontrib><creatorcontrib>Kondziella, Daniel</creatorcontrib><creatorcontrib>Taran, Shaurya</creatorcontrib><creatorcontrib>Estraneo, Anna</creatorcontrib><creatorcontrib>Shutter, Lori</creatorcontrib><creatorcontrib>Curing Coma Campaign, its Contributing Members</creatorcontrib><creatorcontrib>the Curing Coma Campaign, its Contributing Members</creatorcontrib><title>Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints</title><title>Neurocritical care</title><addtitle>Neurocrit Care</addtitle><addtitle>Neurocrit Care</addtitle><description>Background
Clinical management of persons with disorders of consciousness (DoC) is dedicated largely to optimizing recovery. However, selecting a measure to evaluate the extent of recovery is challenging because few measures are designed to precisely assess the full range of potential outcomes, from prolonged DoC to return of preinjury functioning. Measures that are designed specifically to assess persons with DoC are often performance-based and only validated for in-person use. Moreover, there are no published recommendations addressing which outcome measures should be used to evaluate DoC recovery. The resulting inconsistency in the measures selected by individual investigators to assess outcome prevents comparison of results across DoC studies. The National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs) is an amalgamation of standardized variables and tools that are recommended for use in studies of neurologic diseases and injuries. The Neurocritical Care Society Curing Coma Campaign launched an initiative to develop CDEs specifically for DoC and invited our group to recommend CDE outcomes and endpoints for persons with DoCs.
Methods
The Curing Coma Campaign Outcomes and Endpoints CDE Workgroup, consisting of experts in adult and pediatric neurocritical care, neurology, and neuroscience, used a previously established five-step process to identify and select candidate CDEs: (1) review of existing NINDS CDEs, (2) nomination and systematic vetting of new CDEs, (3) CDE classification, (4) iterative review and approval of panel recommendations, and (5) development of case report forms.
Results
Among hundreds of existing NINDS outcome and endpoint CDE measures, we identified 20 for adults and 18 for children that can be used to assess the full range of recovery from coma. We also proposed 14 new outcome and endpoint CDE measures for adults and 5 for children.
Conclusions
The DoC outcome and endpoint CDEs are a starting point in the broader effort to standardize outcome evaluation of persons with DoC. The ultimate goal is to harmonize DoC studies and allow for more precise assessment of outcomes after severe brain injury or illness. An iterative approach is required to modify and adjust these outcome and endpoint CDEs as new evidence emerges.</description><subject>Clinical outcomes</subject><subject>Coma</subject><subject>Common Data Elements</subject><subject>Common Data Elements for Disorders of Consciousness</subject><subject>Consciousness</subject><subject>Consciousness Disorders - diagnosis</subject><subject>Consciousness Disorders - therapy</subject><subject>Critical Care Medicine</subject><subject>Data collection</subject><subject>Humans</subject><subject>Intensive</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>National Institute of Neurological Disorders and Stroke (U.S.) - standards</subject><subject>Neurology</subject><subject>Neuropsychology</subject><subject>Neurosurgery</subject><subject>Outcome Assessment, Health Care - standards</subject><subject>Patients</subject><subject>Pediatrics</subject><subject>Quality of life</subject><subject>Stroke</subject><subject>Traumatic brain injury</subject><issn>1541-6933</issn><issn>1556-0961</issn><issn>1556-0961</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UV1rFTEQDWKx9eof8EECvviyNpPsJru-ye21FgoFUXwM-zGpW-8m18wu0n_T39Jf1qm3KvjQQMjAnHPmTI4Qr0C9A6XcMYFWui6ULvkqWxfwRBxBVdlCNRae3tclFLYx5lA8J7pSSrvGVc_EoWmgNMZVR-LXOk1TivKknVu52eKEcSYZUpYnI6U8YCaZglynSP2YFopI9F5-xp5pGId2HrkjQ06TnL-j_JbyjzFeytOclp1k3YtlZiiSbOMgb282cdilkUe8EAeh3RK-fHhX4uvHzZf1p-L84vRs_eG86HVl5wKCcuwZ2lAjH2e5stZU2oQasCuhrsuGPyDU2nR9WTWghm6odOeCC-i0WYm3e91dTj8XpNlPI_W43bYReR1vVGPAacuiK_HmP-hVWnJkd96AAqVBl45Reo_qcyLKGPwuj1Obrz0ofx-L38fi2ZX_HYsHJr1-kF66CYe_lD85MMDsAcSteIn53-xHZO8Ar_WY4Q</recordid><startdate>20241001</startdate><enddate>20241001</enddate><creator>Bodien, Yelena G.</creator><creator>LaRovere, Kerri</creator><creator>Kondziella, Daniel</creator><creator>Taran, Shaurya</creator><creator>Estraneo, Anna</creator><creator>Shutter, Lori</creator><general>Springer US</general><general>Springer Nature B.V</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>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-4858-2903</orcidid></search><sort><creationdate>20241001</creationdate><title>Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints</title><author>Bodien, Yelena G. ; LaRovere, Kerri ; Kondziella, Daniel ; Taran, Shaurya ; Estraneo, Anna ; Shutter, Lori</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c256t-1f077971af8eeee761af663523f81eb418849024f823bc45910dbd52b7f7fe723</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Clinical outcomes</topic><topic>Coma</topic><topic>Common Data Elements</topic><topic>Common Data Elements for Disorders of Consciousness</topic><topic>Consciousness</topic><topic>Consciousness Disorders - diagnosis</topic><topic>Consciousness Disorders - therapy</topic><topic>Critical Care Medicine</topic><topic>Data collection</topic><topic>Humans</topic><topic>Intensive</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>National Institute of Neurological Disorders and Stroke (U.S.) - standards</topic><topic>Neurology</topic><topic>Neuropsychology</topic><topic>Neurosurgery</topic><topic>Outcome Assessment, Health Care - standards</topic><topic>Patients</topic><topic>Pediatrics</topic><topic>Quality of life</topic><topic>Stroke</topic><topic>Traumatic brain injury</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bodien, Yelena G.</creatorcontrib><creatorcontrib>LaRovere, Kerri</creatorcontrib><creatorcontrib>Kondziella, Daniel</creatorcontrib><creatorcontrib>Taran, Shaurya</creatorcontrib><creatorcontrib>Estraneo, Anna</creatorcontrib><creatorcontrib>Shutter, Lori</creatorcontrib><creatorcontrib>Curing Coma Campaign, its Contributing Members</creatorcontrib><creatorcontrib>the Curing Coma Campaign, its Contributing Members</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Neurocritical care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bodien, Yelena G.</au><au>LaRovere, Kerri</au><au>Kondziella, Daniel</au><au>Taran, Shaurya</au><au>Estraneo, Anna</au><au>Shutter, Lori</au><aucorp>Curing Coma Campaign, its Contributing Members</aucorp><aucorp>the Curing Coma Campaign, its Contributing Members</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints</atitle><jtitle>Neurocritical care</jtitle><stitle>Neurocrit Care</stitle><addtitle>Neurocrit Care</addtitle><date>2024-10-01</date><risdate>2024</risdate><volume>41</volume><issue>2</issue><spage>357</spage><epage>368</epage><pages>357-368</pages><issn>1541-6933</issn><issn>1556-0961</issn><eissn>1556-0961</eissn><abstract>Background
Clinical management of persons with disorders of consciousness (DoC) is dedicated largely to optimizing recovery. However, selecting a measure to evaluate the extent of recovery is challenging because few measures are designed to precisely assess the full range of potential outcomes, from prolonged DoC to return of preinjury functioning. Measures that are designed specifically to assess persons with DoC are often performance-based and only validated for in-person use. Moreover, there are no published recommendations addressing which outcome measures should be used to evaluate DoC recovery. The resulting inconsistency in the measures selected by individual investigators to assess outcome prevents comparison of results across DoC studies. The National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs) is an amalgamation of standardized variables and tools that are recommended for use in studies of neurologic diseases and injuries. The Neurocritical Care Society Curing Coma Campaign launched an initiative to develop CDEs specifically for DoC and invited our group to recommend CDE outcomes and endpoints for persons with DoCs.
Methods
The Curing Coma Campaign Outcomes and Endpoints CDE Workgroup, consisting of experts in adult and pediatric neurocritical care, neurology, and neuroscience, used a previously established five-step process to identify and select candidate CDEs: (1) review of existing NINDS CDEs, (2) nomination and systematic vetting of new CDEs, (3) CDE classification, (4) iterative review and approval of panel recommendations, and (5) development of case report forms.
Results
Among hundreds of existing NINDS outcome and endpoint CDE measures, we identified 20 for adults and 18 for children that can be used to assess the full range of recovery from coma. We also proposed 14 new outcome and endpoint CDE measures for adults and 5 for children.
Conclusions
The DoC outcome and endpoint CDEs are a starting point in the broader effort to standardize outcome evaluation of persons with DoC. The ultimate goal is to harmonize DoC studies and allow for more precise assessment of outcomes after severe brain injury or illness. An iterative approach is required to modify and adjust these outcome and endpoint CDEs as new evidence emerges.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>39143375</pmid><doi>10.1007/s12028-024-02068-1</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0003-4858-2903</orcidid></addata></record> |
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| subjects | Clinical outcomes Coma Common Data Elements Common Data Elements for Disorders of Consciousness Consciousness Consciousness Disorders - diagnosis Consciousness Disorders - therapy Critical Care Medicine Data collection Humans Intensive Internal Medicine Medicine Medicine & Public Health National Institute of Neurological Disorders and Stroke (U.S.) - standards Neurology Neuropsychology Neurosurgery Outcome Assessment, Health Care - standards Patients Pediatrics Quality of life Stroke Traumatic brain injury |
| title | Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Outcomes and Endpoints |
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