DEVELOPMENT OF A GUIDANCE ON THE IMPLEMENTATION AND USE OF EORTC INSTRUMENTS IN ELECTRONIC APPLICATIONS

Author(s)

Kulis D1, Bottomley A1, Holzner B2, Koller M3, Swinburn P4, Itani A5
1EORTC, Brussels, Belgium, 2Medical University of Innsbruck, Innsbruck, Austria, 3University Hospital Regensburg, Regensburg, Germany, 4Mapi Group, London, UK, 5Mapi, Lyon, France

OBJECTIVES: With the increased use of electronic patient-reported outcome (ePRO) measures in clinical research, the European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) has undertaken the development of a guidance document to assist parties interested in using any of the EORTC instruments in an electronic format. The intent of this guidance is to provide a framework for the implementation and use of these instruments in a consistent and controlled fashion. The objective of this abstract is to present the structure and content of this guidance. METHODS:  A working group gathering representatives of the EORTC QLG, and Mapi was set up. RESULTS:  The guidance is organised into four parts: introduction, ePRO development and certification process, definitions, and EORTC requirements. The EORTC requirements section is the core part of the guidance. Its introduction specifies that the methodology applied in the EORTC process will follow ISPOR requirements. Recommendations about 1) Migration of the original, 2) Testing, and 3) Translations migration and certification are provided. Regarding migration of the original, the EORTC presents general considerations (e.g., issues related to accessibility), develops requirements about navigation (e.g., user should be permitted to revisit items), how ID, birthdate and completion date should be generated, details how instructions and item response should be displayed, and how ending item completion should be organised. As for testing, recommendations about beta-testing, usability testing, and equivalence studies are presented. Regarding translations, the EORTC recommends that migration can be initiated once the eformat of the original has been approved, has gone through all testings and has been certified. Then, screenshots in each target language should be reviewed, corrected (if needed), and certified. CONCLUSIONS: This guidance provides a robust framework for the implementation and use of the EORTC instruments in electronic applications, answering the needs of commercial partners.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PRM188

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Oncology

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