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

Authors

  • Adrian Sayers Muscloskeletal Research Unit, School of Clinical Sciences, University of Bristol, Bristol, UKSchool of Social and Community Medicine, University of Bristol, Bristol, UK PubMed articlesGoogle scholar articles
  • Michael J Crowther Biostatistics Research Group, Department of Health Sciences, College of Medicine, Biological Sciences and Psychology, University of Leicester, Centre for Medicine, University Road, Leicester, UK PubMed articlesGoogle scholar articles
  • Andrew Judge NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UKMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK PubMed articlesGoogle scholar articles
  • Michael R Whitehouse Muscloskeletal Research Unit, School of Clinical Sciences, University of Bristol, Bristol, UK PubMed articlesGoogle scholar articles
  • Ashley W Blom Muscloskeletal Research Unit, School of Clinical Sciences, University of Bristol, Bristol, UK PubMed articlesGoogle scholar articles
  1. Correspondence to Adrian Sayers; adrian.sayers{at}bristol.ac.uk
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Citation

Sayers A, Crowther MJ, Judge A, et al
Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark
BMJ Open 2017;7:e015397. doi: 10.1136/bmjopen-2016-015397

Publication history

  • Received December 1, 2016
  • Revised May 29, 2017
  • Accepted July 4, 2017
  • First published August 28, 2017.
Online issue publication 
August 28, 2017
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© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/