TY - JOUR
T1 - Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology
AU - Buch, Maya H.
AU - Silva-Fernandez, Lucia
AU - Carmona, Loreto
AU - Aletaha, Daniel
AU - Christensen, Robin
AU - Combe, Bernard
AU - Emery, Paul
AU - Ferraccioli, Gianfranco
AU - Guillemin, Francis
AU - Kvien, Tore K.
AU - Landewe, Robert
AU - Pavelka, Karel
AU - Saag, Kenneth
AU - Smolen, Josef S.
AU - Symmons, Deborah
AU - van der Heijde, Désirée
AU - Welling, Joep
AU - Wells, George
AU - Westhovens, Rene
AU - Zink, Angela
AU - Boers, Maarten
PY - 2015
Y1 - 2015
N2 - 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. 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. 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. 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
AB - 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. 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. 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. 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
U2 - https://doi.org/10.1136/annrheumdis-2013-204948
DO - https://doi.org/10.1136/annrheumdis-2013-204948
M3 - Article
C2 - 24827533
SN - 0003-4967
VL - 74
SP - 963
EP - 969
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 6
ER -