RT Journal Article
SR Electronic
T1 Towards consensus in defining and handling contextual factors within rheumatology trials: an initial qualitative study from an OMERACT working group
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 242
OP 249
DO 10.1136/annrheumdis-2020-217895
VO 80
IS 2
A1 Sabrina Mai Nielsen
A1 Marianne Uggen Rasmussen
A1 Maarten Boers
A1 Danielle A van der Windt
A1 Maarten de Wit
A1 Thasia G Woodworth
A1 Caroline A Flurey
A1 Dorcas Beaton
A1 Beverley Shea
A1 Reuben Escorpizo
A1 Daniel E Furst
A1 Josef S Smolen
A1 Karine Toupin-April
A1 Annelies Boonen
A1 Marieke Voshaar
A1 Torkell Ellingsen
A1 George A Wells
A1 Barnaby C Reeves
A1 Lyn March
A1 Peter Tugwell
A1 Robin Christensen
YR 2021
UL http://ard.bmj.com/content/80/2/242.abstract
AB Objectives The Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term ‘contextual factors’ exist. This study explores the perspectives of researchers (including clinicians) and patients in defining 'contextual factor’ and its related terminology, identifying such factors and accounting for them in trials across rheumatology.Methods We conducted individual semistructured interviews with researchers (including clinicians) who have experience within the field of contextual factors in clinical trials or other potentially relevant areas, and small focus group interviews with patients with rheumatic conditions. We transcribed the interviews and applied qualitative content analysis.Results We interviewed 12 researchers and 7 patients. Researcher's and patient's descriptions of contextual factors were categorised into two broad themes, each comprising two contextual factors types. The ‘treatment effect’ theme focused on factors explaining variations in treatment effects (A) among patients and (B) among studies. The ‘outcome measurement’ theme focused on factors that explain (C) variations in the measurement result itself (apart from actual changes/differences in the outcome) and (D) variations in the outcome itself (beside treatment of interest). Methods for identifying and handling contextual factors differed among these themes and types.Conclusions Two main themes for contextual factors with four types of contextual factors were identified based on input from researchers and patients. This will guide operationalisation of contextual factors. Further research should refine our findings and establish consensus among relevant stakeholders.