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If you use this dataset in a publication, please cite the dataset, and include the following in the citation: author; year; dataset title; dataset DOI; datase version; repository.","conditions":"See UMC Utrecht license","disclaimer":"It is expressly understood that UMC Utrecht does not make any warranties regarding the data and specifically does not warrant or guarantee that the data will be accurate, be merchantable or useful for any particular purpose. Use of the data is at your own risk. UMC Utrecht cannot and shall not be held liable for any claims or damages by you or any third party, in connection with or as a result of the use of data by you. ","termsOfAccess":"By downloading or otherwise accessing the materials, the downloader represents his/her acceptance of the Terms of Use. ","fileAccessRequest":false,"metadataBlocks":{"citation":{"displayName":"Citation Metadata","name":"citation","fields":[{"typeName":"title","multiple":false,"typeClass":"primitive","value":"Replication Data for: Remote monitoring of amyotrophic lateral sclerosis using wearable sensors detects differences in disease progression and survival: a prospective cohort study"},{"typeName":"author","multiple":true,"typeClass":"compound","value":[{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"van Unnik, Jordi"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"van Eijk, RPA"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}}]},{"typeName":"datasetContact","multiple":true,"typeClass":"compound","value":[{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"van Unnik, JWJ"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"van Eijk, RPA"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"Datamanager"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}}]},{"typeName":"dsDescription","multiple":true,"typeClass":"compound","value":[{"dsDescriptionValue":{"typeName":"dsDescriptionValue","multiple":false,"typeClass":"primitive","value":"<b>Background:</b> There is an urgent need for objective and more sensitive measures to quantify clinical disease progression and gauge the response to treatment in clinical trials for amyotrophic lateral sclerosis (ALS). Here, we evaluate the ability of a novel accelerometer-derived outcome to detect differential clinical disease progression and assess its longitudinal associations with overall survival in patients with ALS.\n<br>\n<br>\n<b>Methods:</b> Patients with ALS wore an accelerometer on the hip for 3-7 days, every 2-3 months during a multi-year observation period. An accelerometer-derived outcome, the Vertical Movement Index (VMI), was calculated, together with predicted disease progression rates, and jointly analyzed with overall survival. The clinical utility of VMI was evaluated with comparisons to patient-reported functionality, whereas the impact of various monitoring schemes on empirical power was explored through simulations.\n<br>\n<br>\n<b>Findings:</b> In total, 97 patients wore the accelerometer for 1,995 days, for a total of 27,701 h. The VMI was highly discriminatory for predicted disease progression rates, revealing faster rates of decline in patients with a worse predicted prognosis compared to those with a better predicted prognosis (p < 0·0001). The VMI was strongly associated with the hazard for death (HR 0·20, 95% CI: 0·09 to 0·44, p = 0.0001), where a decrease of 0·19 to 0·41 unit was associated with reduced ambulatory status. Recommendations for future studies using accelerometry are provided.\n<br>\n<br>\n<b>Interpretation:</b> The results serve as motivation to incorporate accelerometer-derived outcomes in clinical trials, which will be essential to further validate these markers to meaningful endpoints.\n<br>\n<br>\n<b>Funding:</b> Stichting ALS Nederland (TRICALS-Reactive-II)."}}]},{"typeName":"subject","multiple":true,"typeClass":"controlledVocabulary","value":["Medicine, Health and Life Sciences"]},{"typeName":"keyword","multiple":true,"typeClass":"compound","value":[{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"amyotrophic lateral sclerosis"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"wearable sensors"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"biomarkers"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"clinical trials"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"remote monitoring"}}]},{"typeName":"publication","multiple":true,"typeClass":"compound","value":[{"publicationCitation":{"typeName":"publicationCitation","multiple":false,"typeClass":"primitive","value":"To be added. Source code is available at: https://github.com/tricals-methodology/remote-monitoring-als"}}]},{"typeName":"depositor","multiple":false,"typeClass":"primitive","value":"van Unnik, Jordi"},{"typeName":"dateOfDeposit","multiple":false,"typeClass":"primitive","value":"2024-01-03"}]},"dansDataVaultMetadata":{"displayName":"Data Vault Metadata","name":"dansDataVaultMetadata","fields":[{"typeName":"dansDataversePid","multiple":false,"typeClass":"primitive","value":"doi:10.34894/QPFHWV"},{"typeName":"dansDataversePidVersion","multiple":false,"typeClass":"primitive","value":"1.0"},{"typeName":"dansBagId","multiple":false,"typeClass":"primitive","value":"urn:uuid:ef59d5f3-af99-4c21-9c8c-27d285f9e2d8"},{"typeName":"dansNbn","multiple":false,"typeClass":"primitive","value":"urn:nbn:nl:ui:13-3dbc8100-913c-4bea-b3ba-eea022176a29"}]}},"files":[{"label":"IRB approval cohort 1_G.pdf","restricted":false,"version":1,"datasetVersionId":25652,"dataFile":{"id":399973,"persistentId":"","filename":"IRB approval cohort 1_G.pdf","contentType":"application/pdf","friendlyType":"Adobe PDF","filesize":530214,"storageIdentifier":"surf://store:18d0d29e75e-50ab214c1b02","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"c1196ae7eb39c343521d502e16277421de22e8f2"},"tabularData":false,"creationDate":"2024-01-15","publicationDate":"2024-01-18","lastUpdateTime":"2024-01-18T08:49:02Z","fileAccessRequest":false}},{"label":"IRB approval cohort 2_G.pdf","restricted":false,"version":1,"datasetVersionId":25652,"dataFile":{"id":399972,"persistentId":"","filename":"IRB approval cohort 2_G.pdf","contentType":"application/pdf","friendlyType":"Adobe PDF","filesize":767483,"storageIdentifier":"surf://store:18d0d29ec7c-243b9bb626dd","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"4e97b2006fa6beaa9d1875936b0e8db9822ea7b0"},"tabularData":false,"creationDate":"2024-01-15","publicationDate":"2024-01-18","lastUpdateTime":"2024-01-18T08:49:02Z","fileAccessRequest":false}},{"label":"Patient information letter cohort 1_G.pdf","restricted":false,"version":1,"datasetVersionId":25652,"dataFile":{"id":399970,"persistentId":"","filename":"Patient information letter cohort 1_G.pdf","contentType":"application/pdf","friendlyType":"Adobe PDF","filesize":447819,"storageIdentifier":"surf://store:18d0d29ee43-22db76c7c992","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"d3cfa970acec8593d32ee0aecd38328f12ea17ff"},"tabularData":false,"creationDate":"2024-01-15","publicationDate":"2024-01-18","lastUpdateTime":"2024-01-18T08:49:02Z","fileAccessRequest":false}},{"label":"Patient information letter cohort 2_G.pdf","restricted":false,"version":1,"datasetVersionId":25652,"dataFile":{"id":399971,"persistentId":"","filename":"Patient information letter cohort 2_G.pdf","contentType":"application/pdf","friendlyType":"Adobe PDF","filesize":728677,"storageIdentifier":"surf://store:18d0d29efc1-88eaa6996d38","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"7a48bb9e8efa246452e5f173a611ef2332e05366"},"tabularData":false,"creationDate":"2024-01-15","publicationDate":"2024-01-18","lastUpdateTime":"2024-01-18T08:49:02Z","fileAccessRequest":false}},{"label":"README.pdf","restricted":false,"version":1,"datasetVersionId":25652,"dataFile":{"id":389964,"persistentId":"","filename":"README.pdf","contentType":"application/pdf","friendlyType":"Adobe PDF","filesize":75873,"storageIdentifier":"surf://store:18cd01d7160-7269f5c90e35","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"3e89edb64500879e9e24370bfa893452b074a29f"},"tabularData":false,"creationDate":"2024-01-03","publicationDate":"2024-01-18","lastUpdateTime":"2024-01-18T08:49:02Z","fileAccessRequest":false}},{"label":"wearablesensorstudy.csv","restricted":false,"version":1,"datasetVersionId":25652,"dataFile":{"id":389966,"persistentId":"","filename":"wearablesensorstudy.csv","contentType":"text/csv","friendlyType":"Comma Separated Values","filesize":63158,"storageIdentifier":"surf://store:18cd01d751a-41fdf61d173d","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"771554a8400a49ca1198d6d67cf1cdf3707d77c5"},"tabularData":false,"creationDate":"2024-01-03","publicationDate":"2024-01-18","lastUpdateTime":"2024-01-18T08:49:02Z","fileAccessRequest":false}}]}}}