Currently submitted to: JMIR Medical Informatics
Date Submitted: Aug 2, 2019
Open Peer Review Period: Aug 5, 2019 - Sep 30, 2019
(closed for review but you can still tweet)
NOTE: This is an unreviewed Preprint
Warning: This is a unreviewed preprint (What is a preprint?). Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note “no longer under consideration” will appear above).
Peer-review me: Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period (in this case, a “Peer-Review Me” button to sign up as reviewer is displayed above). All preprints currently open for review are listed here. Outside of the formal open peer-review period we encourage you to tweet about the preprint.
Citation: Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).
Final version: If our system detects a final peer-reviewed “version of record” (VoR) published in any journal, a link to that VoR will appear below. Readers are then encourage to cite the VoR instead of this preprint.
Settings: If you are the author, you can login and change the preprint display settings, but the preprint URL/DOI is supposed to be stable and citable, so it should not be removed once posted.
Submit: To post your own preprint, simply submit to any JMIR journal, and choose the appropriate settings to expose your submitted version as preprint.
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.
Request queued. Please wait while the file is being generated. It may take some time.
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.