Using an Innovative Approach to Build a Prospective Diabetes Cohort Registry of Patients With Type 2 Diabetes in Germany: DIAREG

Abstract

A553 clarifying and updating ClinRO information. Methods: PROQOLID was searched on April 9, 2014 to retrieve current information about ClinROs using an advanced search engine. Results: The ClinRO information was found under the category "mode of administration" in the subcategory "clinician-rated." Out of the 801 questionnaires in the database, fifty-two (6.5%) were identified as ClinROs. Out of these 52 questionnaires, nine were generic. Eight different therapeutic areas were identified (i.e., digestive system diseases, musculoskeletal diseases, neoplasms, nervous system diseases, respiratory tract diseases, psychiatric disorders, pathological conditions signs and symptoms, and skin and connective tissue diseases), representing 17 different indications, and 33.33% of the therapeutic areas included in PROQOLID (n= 24). The most represented therapeutic area was psychiatry (n= 23) followed by nervous diseases (n= 7). Only two questionnaires were specific to children: the Pediatric Evaluation of Disabilty Inventory and the WeeFIM ® . To better individualize ClinRO information in PROQOLID, it is proposed to create a new meta-category, i.e., type of COA (PRO, ClinRO, ObsRO and PerfRO). It is also recommended to expand PROQOLID to all COAs. ConClusions: This review has shown that PROQOLID already includes ClinRO information. Recommendations are given on how to modify the organization and content of the database to present information on all COAs.objeCtives: Electronic Clinical Outcome Assessments (eCOAs) are increasingly being used in clinical trials and their use is encouraged by regulatory authorities. Licensing is a key issue for their appropriate utilization. The objective of this abstract is to make recommendations about eCOA licensing using lessons learned from the COA translation licensing. Methods: Publications about licensing of COA translations were searched and a review of the eCOAs specificities was performed using information available from e-vendors. Results: Very few publications exist about the licensing of COA translations. The ISOQOL TCA SIG has developed a draft reflection paper which considers that translations are derivative work of original questionnaires. As such, they recommend that the copyright of a COA and its translations should be owned by a unique entity, generally the original developer to harmonize and facilitate conditions of access and use. They state that distribution should be centralized to facilitate access to questionnaires, maintain reliable information about them, and control their use. Review of the e-vendors information shows that eCOAs are often customized, with proprietary devices and softwares, and cannot be shared across users. As a consequence, there is a multiplication of e-versions for a same content. Equivalence between paper and e-versions and between e-versions is then a major concern. The review also shows that migration from paper to the electronic platform/device implies changes to the content and format of the paper version. Therefore the eCOAs can be considered ...