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dc.contributor.authorLockery, J.E.
dc.contributor.authorCollyer, T.A.
dc.contributor.authorReid, Christopher
dc.contributor.authorErnst, M.E.
dc.contributor.authorGilbertson, D.
dc.contributor.authorHay, N.
dc.contributor.authorKirpach, B.
dc.contributor.authorMcNeil, J.J.
dc.contributor.authorNelson, M.R.
dc.contributor.authorOrchard, S.G.
dc.contributor.authorPruksawongsin, K.
dc.contributor.authorShah, R.C.
dc.contributor.authorWolfe, R.
dc.contributor.authorWoods, R.L.
dc.date.accessioned2020-07-16T04:03:22Z
dc.date.available2020-07-16T04:03:22Z
dc.date.issued2019
dc.identifier.citationLockery, J.E. and Collyer, T.A. and Reid, C.M. and Ernst, M.E. and Gilbertson, D. and Hay, N. and Kirpach, B. et al. 2019. Overcoming challenges to data quality in the ASPREE clinical trial. Trials. 20 (1): Article No. 686.
dc.identifier.urihttp://hdl.handle.net/20.500.11937/80064
dc.identifier.doi10.1186/s13063-019-3789-2
dc.description.abstract

© 2019 The Author(s). Background: Large-scale studies risk generating inaccurate and missing data due to the complexity of data collection. Technology has the potential to improve data quality by providing operational support to data collectors. However, this potential is under-explored in community-based trials. The Aspirin in reducing events in the elderly (ASPREE) trial developed a data suite that was specifically designed to support data collectors: the ASPREE Web Accessible Relational Database (AWARD). This paper describes AWARD and the impact of system design on data quality. Methods: AWARD's operational requirements, conceptual design, key challenges and design solutions for data quality are presented. Impact of design features is assessed through comparison of baseline data collected prior to implementation of key functionality (n = 1000) with data collected post implementation (n = 18,114). Overall data quality is assessed according to data category. Results: At baseline, implementation of user-driven functionality reduced staff error (from 0.3% to 0.01%), out-of-range data entry (from 0.14% to 0.04%) and protocol deviations (from 0.4% to 0.08%). In the longitudinal data set, which contained more than 39 million data values collected within AWARD, 96.6% of data values were entered within specified query range or found to be accurate upon querying. The remaining data were missing (3.4%). Participant non-attendance at scheduled study activity was the most common cause of missing data. Costs associated with cleaning data in ASPREE were lower than expected compared with reports from other trials. Conclusions: Clinical trials undertake complex operational activity in order to collect data, but technology rarely provides sufficient support. We find the AWARD suite provides proof of principle that designing technology to support data collectors can mitigate known causes of poor data quality and produce higher-quality data. Health information technology (IT) products that support the conduct of scheduled activity in addition to traditional data entry will enhance community-based clinical trials. A standardised framework for reporting data quality would aid comparisons across clinical trials.

dc.languageEnglish
dc.publisherBMC
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectScience & Technology
dc.subjectLife Sciences & Biomedicine
dc.subjectMedicine, Research & Experimental
dc.subjectResearch & Experimental Medicine
dc.subjectHealth data
dc.subjectClinical trial
dc.subjectData quality
dc.subjectHealth technology
dc.subjectLOW-DOSE ASPIRIN
dc.subjectPRIMARY PREVENTION
dc.subjectREDUCING EVENTS
dc.subjectRANDOMIZED-TRIAL
dc.subjectELDERLY ASPREE
dc.subjectUSABILITY
dc.subjectSAFETY
dc.subjectCARE
dc.titleOvercoming challenges to data quality in the ASPREE clinical trial
dc.typeJournal Article
dcterms.source.volume20
dcterms.source.number1
dcterms.source.issn1745-6215
dcterms.source.titleTrials
dc.date.updated2020-07-16T04:03:18Z
curtin.departmentSchool of Public Health
curtin.accessStatusOpen access
curtin.facultyFaculty of Health Sciences
curtin.contributor.orcidReid, Christopher [0000-0001-9173-3944]
curtin.identifier.article-numberARTN 686
dcterms.source.eissn1745-6215


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