Towards consensus in defining and handling contextual factors within rheumatology trials: an initial qualitative study from an OMERACT working group.
Sabrina Mai NielsenMarianne Uggen RasmussenMaarten BoersDanielle A van der WindtMaarten P T de WitThasia G WoodworthCaroline A FlureyDorcas E BeatonBeverley SheaReuben EscorpizoDaniel E FurstJosef S SmolenKarine Toupin AprilAnnelies BoonenMarieke VoshaarTorkell J EllingsenGeorge A WellsBarnaby C ReevesLyn M MarchPeter TugwellRobin ChristensenPublished in: Annals of the rheumatic diseases (2020)
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.