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Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting

Abstract:

Objectives Prespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports. Study design Methodological review. Methods We searched four journals throu...

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1136/bmjopen-2020-048178

Authors


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Institution:
University of Oxford
Division:
MSD
Department:
NDORMS
Oxford college:
St Edmund Hall
Role:
Author
ORCID:
0000-0002-4054-5975
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Role:
Author
ORCID:
0000-0003-3529-2739
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Publisher:
BMJ Publishing Group Publisher's website
Journal:
BMJ Open Journal website
Volume:
11
Issue:
6
Article number:
e048178
Publication date:
2021-06-28
Acceptance date:
2021-06-08
DOI:
EISSN:
2044-6055
Pmid:
34183348
Language:
English
Keywords:
Pubs id:
1184401
Local pid:
pubs:1184401
Deposit date:
2021-07-08

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