Methods for evaluating innovative surgery: a nested ideal phase 2 study within an external randomised pilot (the ROMIO trial)
作者： Jane Blazeby , Richard Berrisford , Dan Titcomb , Andrew Hollowood , Grant Sanders
DOI: 10.1186/1745-6215-16-S2-O54
关键词: Randomized controlled trial 、 Design studies 、 Surgery 、 Ideal (set theory) 、 Psychological intervention 、 Medicine
摘要: Pragmatic surgical RCTs are needed but it is unclear how to design studies with evolving innovative interventions. The aim of this paper was describe a pilot RCT comparing two standard techniques incorporated an additional randomised group nested IDEAL (Idea, Development, Evaluation, Assessment and Long-term evaluation surgery) Phase 2b technique inform main trial design.
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