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Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark

Abstract:
Objectives: The use of benchmarks to assess the performance of implants such as those used in arthroplasty surgery is a widespread practice. It provides surgeons, patients and regulatory authorities with the reassurance that implants used are safe and effective. However, it is not currently clear how or how many implants should be statistically compared to a benchmark to assess whether or not that implant is superior, equivalent, non-inferior, or inferior to the performance b... Expand abstract
Publication status:
Published
Peer review status:
Peer reviewed
Version:
Publisher's version

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Publisher copy:
10.1136/bmjopen-2016-015397

Authors


Crowther, MJ More by this author
More by this author
Department:
Oxford, MSD, NDORMS
Whitehouse, MR More by this author
Publisher:
BMJ Publishing Group Publisher's website
Journal:
BMJ Open Journal website
Volume:
7
Issue:
8
Pages:
Article: e015397
Publication date:
2017-08-28
Acceptance date:
2017-07-04
DOI:
ISSN:
2044-6055
Pubs id:
pubs:710068
URN:
uri:e14e6f6f-ed80-49ac-b193-091d6e6f649c
UUID:
uuid:e14e6f6f-ed80-49ac-b193-091d6e6f649c
Local pid:
pubs:710068

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