Currently accepted at: JMIR Medical Informatics
Date Submitted: Aug 2, 2019
Open Peer Review Period: Aug 5, 2019 - Sep 30, 2019
Date Accepted: Mar 28, 2020
Date Submitted to PubMed: May 22, 2020
(closed for review but you can still tweet)
Applied practice and possible leverage points for information technology support for the screening for clinical trials: A qualitative study
One of the most challenging and most meaningful designs in medical research are clinical trials (CTs). One essential step before starting a CT is screening, i.e. to identify patients which fulfill the inclusion and do not fulfill the exclusion criteria. The screening for CTs might be supported by means of modern information technologies.
The objectives of this explorative study were to get insight which tools for feasibility estimations and for patient screening are actually used in clinical routine and, second, in which way and of which kind information technology could support the clinical staff.
Semi-standardized interviews were performed in five wards (cardiology, gynaecology, gastroenterology, nephrology, and palliative care) in a German university hospital. Four of the interviewees were directly involved in patient screening. Three of them were clinicians, one was a study nurse, and one was a research assistant.
Overall, the actual state of study feasibility estimation and the screening procedure was dominated by human communication and estimations from memory, although there would be many possibilities where IT support could assist. Success mostly depends on experience and the personal motivation. Electronic support was used, but with little importance so far. Searches in ward-specific patient registers (data bases) and searches in Clinical Information Systems were reported. Furthermore, free text searches in medical reports were mentioned. No preference whether pro-active or passive systems would be desired for potentially future applications was expressed. Most of the interviewees saw potential for improvement of the actual systems, but they were also largely satisfied with the outcome of the current approach. Most of the interviewees were interested in learning more about the possibilities how IT could support and relieve them in their clinical routine.
Overall, IT support has a minor standing in the screening for CTs today. The lack of IT usage and the estimations from memory that were reported by all of the participants, might bind cognitive resources which might distract from clinical routine. We conclude that the screening for CT is still a challenge for electronic support and that education of the staff about the possibilities is necessary.
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