ArticleApplied clinical informatics2011
HIS-Based Support of Follow-Up Documentation - Concept and Implementation for Clinical Studies.
Article in Applied clinical informatics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- CIS-based registration of quality of life in a single source approach.BMC medical informatics and decision making · 2011Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveFollow-up data must be collected according to the protocol of each clinical study, i.e. at certain time points. Missing follow-up information is a critical problem and may impede or bias the analysis of study data and result in delays. Moreover, additional patient recruitment may be necessary due to incomplete follow-up data. Current electronic data capture (EDC) systems in clinical studies are usually separated from hospital information systems (HIS) and therefore can provide limited functionality to support clinical workflow. In two case studies, we assessed the feasibility of HIS-based support of follow-up documentation.
methodsWe have developed a data model and a HIS-based workflow to provide follow-up forms according to clinical study protocols. If a follow-up form was due, a database procedure created a follow-up event which was translated by a communication server into an HL7 message and transferred to the import interface of the clinical information system (CIS). This procedure generated the required follow-up form and enqueued a link to it in a work list of the relating study nurses and study physicians, respectively.
resultsA HIS-based follow-up system automatically generated follow-up forms as defined by a clinical study protocol. These forms were scheduled into work lists of study nurses and study physicians. This system was integrated into the clinical workflow of two clinical studies. In a study from nuclear medicine, each scenario from the test concept according to the protocol of the single photon emission computer tomography/computer tomography (SPECT/CT) study was simulated and each scenario passed the test. For a study in psychiatry, 128 follow-up forms were automatically generated within 27 weeks, on average five forms per week (maximum 12, minimum 1 form per week).
conclusionHIS-based support of follow-up documentation in clinical studies is technically feasible and can support compliance with study protocols.
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