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","contactForAccess":"Please fill out the <a href=\"https://www.umcutrecht.nl/en/data-request-form-umc-utrecht\">request form</a>.","fileAccessRequest":false,"metadataBlocks":{"citation":{"displayName":"Citation Metadata","name":"citation","fields":[{"typeName":"title","multiple":false,"typeClass":"primitive","value":"Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: a randomised controlled non-inferiority trial"},{"typeName":"subtitle","multiple":false,"typeClass":"primitive","value":"PLOTS"},{"typeName":"author","multiple":true,"typeClass":"compound","value":[{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Roger A.M.J. Damoiseaux"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands"},"authorIdentifierScheme":{"typeName":"authorIdentifierScheme","multiple":false,"typeClass":"controlledVocabulary","value":"ORCID"},"authorIdentifier":{"typeName":"authorIdentifier","multiple":false,"typeClass":"primitive","value":"0000-0001-8052-0302"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Anne GM Schilder"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"National Institute for Health Research University College London Hospitals Biomedical Research Centre.  evidENT, Ear Institute, University College London, London, United Kingdom"},"authorIdentifierScheme":{"typeName":"authorIdentifierScheme","multiple":false,"typeClass":"controlledVocabulary","value":"ORCID"},"authorIdentifier":{"typeName":"authorIdentifier","multiple":false,"typeClass":"primitive","value":"0000-0002-5496-4580"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Roderick P. Venekamp"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands"},"authorIdentifierScheme":{"typeName":"authorIdentifierScheme","multiple":false,"typeClass":"controlledVocabulary","value":"ORCID"},"authorIdentifier":{"typeName":"authorIdentifier","multiple":false,"typeClass":"primitive","value":"0000-0002-1446-9614"}},{"authorName":{"typeName":"authorName","multiple":false,"typeClass":"primitive","value":"Saskia Hullegie"},"authorAffiliation":{"typeName":"authorAffiliation","multiple":false,"typeClass":"primitive","value":"Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands"},"authorIdentifierScheme":{"typeName":"authorIdentifierScheme","multiple":false,"typeClass":"controlledVocabulary","value":"ORCID"},"authorIdentifier":{"typeName":"authorIdentifier","multiple":false,"typeClass":"primitive","value":"0000-0003-3413-1423"}}]},{"typeName":"datasetContact","multiple":true,"typeClass":"compound","value":[{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"data management"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"UMC Utrecht"}},{"datasetContactName":{"typeName":"datasetContactName","multiple":false,"typeClass":"primitive","value":"Roderick P Venekamp"},"datasetContactAffiliation":{"typeName":"datasetContactAffiliation","multiple":false,"typeClass":"primitive","value":"Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands"}}]},{"typeName":"dsDescription","multiple":true,"typeClass":"compound","value":[{"dsDescriptionValue":{"typeName":"dsDescriptionValue","multiple":false,"typeClass":"primitive","value":"The PLOTS trial is a primary care-based, open randomised, controlled non-inferiority trial. Children presenting with AOMd and ear pain and/or fever were assigned to hydrocortisone-bacitracin-colistin eardrops (five drops, three times per day in the discharging ear(s)) or amoxicillin oral suspension (50 mg/kg body weight per day, divided over three doses) for 7 days. From December 2017 until March 2023, 58 children aged 6 months to 12 years were enrolled. Due to supply issues of the study medication, the trial was put on hold from 8 August 2018 through November 2021. The rationale and design haven been reported in detail elsewhere (see related publication). At baseline and after 2 weeks home visit data was collected. During these visits physical examination, including otoscopy was performed. Children were followed during 3 months. The first two weeks parents kept a daily diary of AOM-related symptoms, adverse events and complications. Thereafter, they kept a weekly diary recording AOM-recurrences, GP consultations, medications use, hospitals admissions and societal costs for AOM for 3 months. Parents completed the OM-specific QoL (OM-6) questionnaire at baseline, 2 weeks and at 3 months and a productivity loss questionnaires (iPCQ) at 2 weeks, 6 weeks and 3 months. In the metadata file all the variables are described. \nThe data are sensitive since they involve personal information of patients. There are also restrictions on use by commercial parties, and on sharing openly based on (inter)national laws and regulations and written informed consent. Therefore these data (and additional clinical data) are only available after PI’s approval and upon signing a Data Sharing Agreement (see Terms of Access) and within a specially designed environment provided by the UMC Utrecht"}}]},{"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":"acute otitis media"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"ear discharge"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"oral antibiotics"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"topical eardrops"}},{"keywordValue":{"typeName":"keywordValue","multiple":false,"typeClass":"primitive","value":"treatment"}}]},{"typeName":"topicClassification","multiple":true,"typeClass":"compound","value":[{"topicClassValue":{"typeName":"topicClassValue","multiple":false,"typeClass":"primitive","value":"Acute Otitis Media"}}]},{"typeName":"publication","multiple":true,"typeClass":"compound","value":[{"publicationCitation":{"typeName":"publicationCitation","multiple":false,"typeClass":"primitive","value":"Hullegie S, Venekamp RP, van Dongen TMA, Mulder S, van Schaik W, de Wit GA, Hay AD, Little P, Moore MV, Sanders EAM, Bonten MJM, Bogaert D, Schilder AG, Damoiseaux RAMJ. Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial. BMJ Open. 2021 Dec 16;11(12):e052128."},"publicationIDType":{"typeName":"publicationIDType","multiple":false,"typeClass":"controlledVocabulary","value":"doi"},"publicationIDNumber":{"typeName":"publicationIDNumber","multiple":false,"typeClass":"primitive","value":"10.1136/bmjopen-2021-052128."}}]},{"typeName":"language","multiple":true,"typeClass":"controlledVocabulary","value":["Dutch"]},{"typeName":"producer","multiple":true,"typeClass":"compound","value":[{"producerName":{"typeName":"producerName","multiple":false,"typeClass":"primitive","value":"Julius Center for Health Sciences and Primary Care (University Medical Center Utrecht)"}}]},{"typeName":"productionPlace","multiple":true,"typeClass":"primitive","value":["the Netherlands"]},{"typeName":"grantNumber","multiple":true,"typeClass":"compound","value":[{"grantNumberAgency":{"typeName":"grantNumberAgency","multiple":false,"typeClass":"primitive","value":"the Netherlands Organisation for Health Research and Development (ZonMw)"},"grantNumberValue":{"typeName":"grantNumberValue","multiple":false,"typeClass":"primitive","value":"84801 5006"}}]},{"typeName":"depositor","multiple":false,"typeClass":"primitive","value":"Saskia Hullegie"},{"typeName":"dateOfDeposit","multiple":false,"typeClass":"primitive","value":"2023-07-31"},{"typeName":"dateOfCollection","multiple":true,"typeClass":"compound","value":[{"dateOfCollectionStart":{"typeName":"dateOfCollectionStart","multiple":false,"typeClass":"primitive","value":"2017-12-12"},"dateOfCollectionEnd":{"typeName":"dateOfCollectionEnd","multiple":false,"typeClass":"primitive","value":"2023-05-25"}}]},{"typeName":"kindOfData","multiple":true,"typeClass":"primitive","value":["clinical data"]},{"typeName":"software","multiple":true,"typeClass":"compound","value":[{"softwareName":{"typeName":"softwareName","multiple":false,"typeClass":"primitive","value":"SPSS"},"softwareVersion":{"typeName":"softwareVersion","multiple":false,"typeClass":"primitive","value":"27.0"}},{"softwareName":{"typeName":"softwareName","multiple":false,"typeClass":"primitive","value":"RStudio"},"softwareVersion":{"typeName":"softwareVersion","multiple":false,"typeClass":"primitive","value":"2023.06.0"}}]}]},"dansDataVaultMetadata":{"displayName":"Data Vault Metadata","name":"dansDataVaultMetadata","fields":[{"typeName":"dansDataversePid","multiple":false,"typeClass":"primitive","value":"doi:10.34894/J4KPP1"},{"typeName":"dansDataversePidVersion","multiple":false,"typeClass":"primitive","value":"1.0"},{"typeName":"dansBagId","multiple":false,"typeClass":"primitive","value":"urn:uuid:3f0a46a7-31e5-4c8b-9c46-6f43f3d3cc0c"},{"typeName":"dansNbn","multiple":false,"typeClass":"primitive","value":"urn:nbn:nl:ui:13-5ba7b5ad-d497-49e2-a3c5-bb4fadbd67e7"}]}},"files":[{"label":"DMP plan_10-08-2023.pdf","restricted":false,"version":1,"datasetVersionId":25246,"dataFile":{"id":380726,"persistentId":"","filename":"DMP plan_10-08-2023.pdf","contentType":"application/pdf","friendlyType":"Adobe PDF","filesize":66242,"storageIdentifier":"surf://store:189dfc3f769-682a910d19da","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"779a5f30cda2313699e1cb38e0b1e2300085bc07"},"tabularData":false,"creationDate":"2023-08-10","publicationDate":"2023-08-11","lastUpdateTime":"2023-08-11T09:34:20Z","fileAccessRequest":false}},{"label":"PLOTS_ALL META FILE_20230530.xlsx","restricted":false,"version":1,"datasetVersionId":25246,"dataFile":{"id":379504,"persistentId":"","filename":"PLOTS_ALL META FILE_20230530.xlsx","contentType":"application/vnd.openxmlformats-officedocument.spreadsheetml.sheet","friendlyType":"MS Excel Spreadsheet","filesize":58561,"storageIdentifier":"surf://store:189b10e57af-47899047a14b","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"142cb4ae86ee0fdf5796e50036ae0ccd9fec1582"},"tabularData":false,"creationDate":"2023-08-01","publicationDate":"2023-08-11","lastUpdateTime":"2023-08-11T09:34:20Z","fileAccessRequest":false}},{"label":"Readme_file_10-08-2023.txt","restricted":false,"version":1,"datasetVersionId":25246,"dataFile":{"id":380729,"persistentId":"","filename":"Readme_file_10-08-2023.txt","contentType":"text/plain","friendlyType":"Plain Text","filesize":1046,"storageIdentifier":"surf://store:189dff447a1-a5db458c2ee9","rootDataFileId":-1,"checksum":{"type":"SHA-1","value":"85793391ca6b6825f5e5b853b1915f768dae3521"},"tabularData":false,"creationDate":"2023-08-10","publicationDate":"2023-08-11","lastUpdateTime":"2023-08-11T09:34:20Z","fileAccessRequest":false}}]}}}