TY - JOUR T1 - Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 963 LP - 969 DO - 10.1136/annrheumdis-2013-204948 VL - 74 IS - 6 AU - Maya H Buch AU - Lucia Silva-Fernandez AU - Loreto Carmona AU - Daniel Aletaha AU - Robin Christensen AU - Bernard Combe AU - Paul Emery AU - Gianfranco Ferraccioli AU - Francis Guillemin AU - Tore K Kvien AU - Robert Landewe AU - Karel Pavelka AU - Kenneth Saag AU - Josef S Smolen AU - Deborah Symmons AU - Désirée van der Heijde AU - Joep Welling AU - George Wells AU - Rene Westhovens AU - Angela Zink AU - Maarten Boers Y1 - 2015/06/01 UR - http://ard.bmj.com/content/74/6/963.abstract N2 - Objectives Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports.Methods We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A ‘0–10’ agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance.Results Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations.Conclusions This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes. ER -