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Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice

Abstract:
Background 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. Methods The By‐Band study was designed in the UK in 2009–2010 to compare the effectiveness o... Expand abstract
Publication status:
Published
Peer review status:
Peer reviewed
Version:
Publisher's Version

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Publisher copy:
10.1002/bjs.10562

Authors


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Department for Environment Food and Rural Affairs (UK) More from this funder
Daniel and Nina Carasso Foundation More from this funder
MMM-MAKERA (Finland) More from this funder
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Grant:
SUSFOOD Call 2014–2017
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Publisher:
Wiley Publisher's website
Journal:
British Journal of Surgery Journal website
Volume:
104
Issue:
9
Pages:
1207-1214
Publication date:
2017-07-13
Acceptance date:
2017-03-16
DOI:
EISSN:
1365-2168
ISSN:
0007-1323
Pubs id:
pubs:709098
URN:
uri:f8e23726-7273-45b6-a2ac-a920f81b3bee
UUID:
uuid:f8e23726-7273-45b6-a2ac-a920f81b3bee
Local pid:
pubs:709098
Language:
English

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