gms | German Medical Science

54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

07. bis 10.09.2009, Essen

ePRO Solution – Design and Compliance

Meeting Abstract

Suche in Medline nach

  • Rainer Richter - Grünenthal GmbH, Aachen
  • Hazel Collie - Grünenthal GmbH, Aachen

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds). Essen, 07.-10.09.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09gmds170

DOI: 10.3205/09gmds170, URN: urn:nbn:de:0183-09gmds1700

Veröffentlicht: 2. September 2009

© 2009 Richter et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Summary: Grünenthal has used ePRO (electronic Patient Reported Outcome) technology to collect patient data in more than 10 trials over the last 5 years.

This presentation will focus on our experience gained in two chronic pain trials and how differences in design can have an impact on compliance with required patient recorded outcomes.

The use of electronic systems to collect Patient Recorded Outcomes (ePRO) is already established in clinical trials. Nevertheless, the design of such an “ediary” can have an impact on the compliance of the patients to complete the required diary measures.

Our experience is based on two clinical trials conducted in approximately 2900 patients where we were assessing chronic pain twice daily. Patients with osteoarthritis of the knee and moderate to severe chronic pain were treated with medication for their pain.

The protocol requirements of the two trials were almost identical but the trials were conducted by 2 different teams, in different geographical regions and both the ediary devices and software providers were different.

We observed that small differences in ediary design can lead to differences in compliance of about 10%. Other, more obvious factors such as gender, age or country do not demonstrate a considerable impact on the compliance.

We will summarize our experience in these two trials, show the difference in the design and the results of comparing the compliance of both trials for different groups.

In our experience, training is the major factor for success.