Previously submitted to: Journal of Medical Internet Research (no longer under consideration since Oct 06, 2018)
Date Submitted: Nov 30, 2017
Open Peer Review Period: Nov 30, 2017 - Mar 15, 2018
(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 Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note "no longer under consideration" will appear above).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.
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
An Account of how Attention to Usability and Lifestyle Issues may Contribute to Protocols for Clinical Trials of Medical Devices
Objectives: Within the field of medicine attempts have been made to establish the efficacy of new treatments with medical devises by double blind randomized clinical trials. Very precise protocols have been developed for this purpose. However, experience has shown that conducting clinical trials on medical devices may be fraught with trouble often because of the difficulty of establishing a valid sham procedure. This paper makes a contribution by showing how one may formulate protocols for clinical trials of medical devices that rely on a pragmatic approach, which includes an interest in usability and lifestyle issues, rather than a sham procedure. Our case in point is a protocol for a clinical trial, conducted by the authors, of a new kind of treatment of epilepsy with a medical device. Methods: This paper makes a methodological contribution relevant for the formulation of protocols for clinical trials of medical devises in cases where a sham devise is not practical. Results: In the paper, we make three major points: (1) abandoning basing a clinical trial of a medical device on a sham procedure, involves making choices as to the formulation of a pragmatic alternative, (2) shifting to a pragmatic evaluation based on data on for example continued use, may involve generating data on usability and lifestyle issues. Understanding to what degree noncompliance is due to usability or lifestyle issues requires attention to the design of suitable instruments for data generation, and (3) the successful formulation of a protocol for a clinical trial of a medical device (where sham is not an option) relies on a case report form (CRF) that facilitates the separation of data on the (somatic) efficacy of the treatment from data on usability and lifestyle issues. Conclusion: Digital devices play an important role in medicine today and in the future. This paper makes a contribution by showing how one may formulate protocols for clinical trials of medical devices that do not rely on a sham procedure. The approach is based on a pragmatic approach, the generating data on usability and lifestyle issues connected to the use of the devise, and the separation of these issues from the evaluation of the efficacy of the active component of the treatment.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© 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.