Currently submitted to: JMIR Medical Informatics
Date Submitted: Aug 2, 2019
Open Peer Review Period: Aug 5, 2019 - Sep 30, 2019
(currently open for review)
Recruitment for Clinical Trials – A Challenge for Electronic Support?
One of the most challenging and most meaningful designs in medical research are clinical trials (CTs). One essential step before a CT can start is recruitment, i.e. to identify patients which fulfill the inclusion and do not fulfill the exclusion criteria. The recruitment for CTs might be supported by means of modern information technologies.
The aims of the present work were 1) to evaluate which (not necessarily electronical) tools are actually used in clinical routine and 2) to evaluate in which way and of which kind electronic support would be helpful for 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 recruitment. Three of them were clinicians, one was a study nurse, and one was a research assistant.
All interviewees reported that either feasibility estimations as well as recruitment is mostly done from memory, although there would be many possibilities where IT support could assist. However, all participants reported some kind of IT support. 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 active or passive systems would be desired for potentially future applications was reported. However, all interviewees stated that, besides IT support, the personal motivation is the most relevant factor for successful recruitment.
Overall, IT support has a minor standing in the recruitment 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 recruitment for CT is still a challenge for electronic support and that education of the clinic staff about the possibilities is compellingly necessary.
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