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

BMJ Open

Volumn 7, Issue 8, 2017, Pages

  Sayers, Adrian ^a   Crowther, Michael J ^b   Judge, Andrew ^c,d   Whitehouse, Michael R ^a   Blom, Ashley W ^a  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b UNIVERSITY OF LEICESTER   (United Kingdom)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

Author keywords

benchmark; competing risks; medical implant; non inferiority; sample size

Indexed keywords

ARTHROPLASTY; ARTICLE; BENCHMARKING; CALCULATION; CONTROLLED STUDY; DEVICE FAILURE; MEASUREMENT ACCURACY; RISK FACTOR; SAMPLE SIZE; STUDY DESIGN; FEMALE; HUMAN; KAPLAN MEIER METHOD; MALE; MEDICAL RESEARCH; METHODOLOGY; PROSTHESES AND ORTHOSES; PROSTHESIS COMPLICATION; STANDARDS;

ARTHROPLASTY; BENCHMARKING; BIOMEDICAL RESEARCH; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; PROSTHESES AND IMPLANTS; PROSTHESIS FAILURE; RESEARCH DESIGN; SAMPLE SIZE;

EID: 85031672876     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-015397     Document Type: Article

References (32)

1. View of a global benchmarking system and international working group progress. Manchester: International Society of Athroplasty Registries, 2016.
2. Kandala NB, Connock M, Pulikottil-Jacob R, et al. Setting benchmark revision rates for total hip replacement: Analysis of registry evidence. BMJ 2015;350:h756.
3. National Institue of clinical excelence. Total hip replacement and resurfacing arthroplasty for end-stage arthritis of the hip 2014.
4. Supply Chain NHS. Orthopaedic Device evaluation panel, 2016. https://www. supplychain. nhs. uk/ odep/.
5. Australian Goverment Department of Health. Prostheses list-Guide to listing and setting benefits for prostheses, 2015. http:// www. health. gov. Au/ internet/ main/ publishing. nsf/ Content/ healthprivatehealth-prostheseslist. htm.
6. Nederlandse Orthopaedische Vereniging. Classification Orthopaedic Implants: NOV Total Hip Prosthesis. 2016. http ://www. o rth ope den. org/ uplo ads/ ky/In/ kyInjf44QX2oW1qhk8PKRA/ HIPLIST-NOV-2016. pdf.
7. Fennema P, Lubsen J. Survival analysis in total joint replacement: An alternative method of accounting for the presence of competing risk. J Bone Joint Surg Br 2010;92:701-6.
8. Putter H, Fiocco M, Geskus RB. Tutorial in biostatistics: competing risks and multi-state models. Stat Med 2007;26:2389-430.
9. Lambert PC, Dickman PW, Nelson CP, et al. Estimating the crude probability of death due to cancer and other causes using relative survival models. Stat Med 2010;29:885-95.
10. Gardner MJ, Altman DG. Confidence intervals rather than P values: estimation rather than hypothesis testing. Br Med J 1986;292:746-50.
11. Sterne JA, Davey Smith G. Sifting the evidence-what's wrong with significance tests BMJ 2001;322:226-31.
12. Bland JM. The tyranny of power: is there a better way to calculate sample size BMJ 2009;339:b3985.
13. Metcalfe C. Statistical power: still an essential element in sample size calculation. Response to: The tyranny of power: is there a better way to calculate sample size BMJ 2010;339:b3985.
14. D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues-the encounters of academic consultants in statistics. Stat Med 2003;22:169-86.
15. Fleming TR. Current issues in non-inferiority trials. Stat Med 2008;27:317-32.
16. Koch GG. Comments on 'Current issues in non-inferiority trials' by Thomas R. Fleming, Statistics in Medicine, Stat Med 2008;27:333-42.
17. Sedgwick P. What is a non-inferiority trial BMJ 2013;347:f6853.
18. Piaggio G, Elbourne DR, Pocock SJ, et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 2012;308:2594-604.
19. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Non-inferiority clinical trials to establish effectiveness guidance for industry, 2016. https://www. fda. gov/ downloads/ Drugs/ Guidances/ UCM202140. pdf. (accessed 4 May 2017).
20. European Medicines Agency (committee for medicinal products for human use). Guideline on the choice of the non-inferiority margin (EMEA/CPMP/EWP/2158/99), 2006. http://www. ema. europa. eu/ docs/ en- GB/ document- library/ Scientific- guideline/ 2009/ 09/ WC500003636. pdf. (accessed 4 MAy 2017).
21. Morris T, White I, Crowther MJ. Using simulation studies to evaluate statistical methods. Unpublished teaching material 2015.
22. Crowther MJ, Lambert PC. Simulating complex survival data. Stata J 2012;12:674-87.
23. Crowther MJ, Lambert PC. Simulating biologically plausible complex survival data. Stat Med 2013;32:4118-34.
24. Registry NJ. 13th Annual Report 2016. Hemel Hempstead 2016.
25. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
26. Kalbfleisch JD, Prentice RL. The statistical analysis of failure Time Data. 2nd ed. New York: Wiley, 2002.
27. Coviello V, Boggess M. Cumulative incidence estimation in the presence of competing risks. The Stata Journal 2004;4:103-11.
28. Crowther MJ, Langan D, Sutton AJ. Graphical augmentations to the funnel plot to assess the impact of a new study on an existing metaanalysis. Stata J 2012;12:605-22.
29. Sutton AJ, Cooper NJ, Jones DR, et al. Evidence-based sample size calculations based upon updated meta-analysis. Stat Med 2007;26:2479-500.
30. Pocock SJ: Clinical trials: A practical approachChichester John Wiley & Sons 1983:147-54.
31. Ranstam J, Kärrholm J, Pulkkinen P, et al. Statistical analysis of arthroplasty data. II. Guidelines. Acta Orthop 2011;82:258-67.
32. Gooley TA, Leisenring W, Crowley J, et al. Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Stat Med 1999;18:695-706.