Open AccessAdaptation of the By‐Band randomized clinical trial to By‐Band‐Sleeve to include a new intervention and maintain relevance of the study to practice
Author(s) -
Rogers C. A.,
Reeves B. C.,
Byrne J.,
Donovan J. L.,
Mazza G.,
Paramasivan S.,
Andrews R. C.,
Wordsworth S.,
Thompson J.,
Blazeby J. M.,
Welbourn R.
Publication year - 2017
Publication title -
british journal of surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.202
H-Index - 201
eISSN - 1365-2168
pISSN - 0007-1323
DOI - 10.1002/bjs.10562
Subject(s) - medicine , randomized controlled trial , adjustable gastric band , sleeve gastrectomy , psychological intervention , adaptation (eye) , intervention (counseling) , physical therapy , surgery , gastric bypass , obesity , weight loss , nursing , physics , optics
Recruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper describes the challenges, rationale and methods for adapting an RCT to include a new intervention.