Journal of Clinical Epidemiology
Volume 64, Issue 3 , Pages 270-279 , March 2011

Bayesian statistical method was underused despite its advantages in the assessment of implantable medical devices

  • Leslie Pibouleau

      Affiliations

    • INSERM, UMR-S717, Paris, F-75000, France
    • Département de Biostatistique et Informatique Médicale, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris F-75000, France
    • Université Paris 7, UMR-S717, Paris, F-75000, France
    • Corresponding Author InformationCorresponding author. Département de Biostatistique et Informatique Médicale, Hôpital Saint Louis, 1 avenue Claude Vellefaux, 75 475 PARIS Cedex 10, France. Tel.: +33-1-42-49-97-42; fax: +33-1-42-49-97-45.
  • ,
  • Sylvie Chevret

      Affiliations

    • INSERM, UMR-S717, Paris, F-75000, France
    • Département de Biostatistique et Informatique Médicale, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris F-75000, France
    • Université Paris 7, UMR-S717, Paris, F-75000, France

,Accepted 26 March 2010.

References 

  1. Ramsey SD, Luce BR, Deyo R, Franklin G. The limited state of technology assessment for medical devices: facing the issues. Am J Manag Care. 1998;4(Spec No(4)):SP188–199
  2. Rapport du Sénat, Le fonctionnement des comités consultatifs de protection des personnes dans la recherche biomédicale, Paris. Available at http://www.senat.fr/rap/r00-267/r00-267.html2001;
  3. Agence Française de Sécurité Sanitaire des Produits de Santé, Rapport annuel. Available at http://www.afssaps.fr/var/afssaps_site/storage/original/application/11a395b6c25d1a12039513abea3f2eec.pdf2007;
  4. Campbell G. Statistics in the world of medical devices: the contrast with pharmaceuticals. J Biopharm Stat. 2008;18:4–19
  5. Konstam MA, Pina I, Lindenfeld J, Packer M. A device is not a drug. J Card Fail. 2003;9:155–157
  6. HAS opinions. Available at http://www.has-sante.fr/portail/jcms/c_5267/actes-produits-de-sante?cid=c_5267
  7. Demets DL. The role of surrogate outcome measures in evaluating medical devices. Surgery. 2000;128:379–385
  8. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324:1448–1451
  9. Solomon MJ, Pager CK, Young JM, Roberts R, Butow P. Patient entry into randomized controlled trials of colorectal cancer treatment: factors influencing participation. Surgery. 2003;133:608–613
  10. Hobbs BP, Carlin BP. Practical Bayesian design and analysis for drug and device clinical trials. J Biopharm Stat. 2008;18:54–80
  11. Pennello G, Thompson L. Experience with reviewing Bayesian medical device trials. J Biopharm Stat. 2008;18:81–115
  12. Spiegelhalter DJ, Freedman LS, Parmar MK. Applying Bayesian ideas in drug development and clinical trials. Stat Med. 1993;12:1501–1511discussion 13–17
  13. Spiegelhalter DJ, Myles JP, Jones DR, Abrams KR. Methods in health service research. An introduction to Bayesian methods in health technology assessment. BMJ. 1999;319:508–512
  14. Berry DA. A case for Bayesianism in clinical trials. Stat Med. 1993;12:1377–1393discussion 95–404
  15. Berry DA. Introduction to Bayesian methods III: use and interpretation of Bayesian tools in design and analysis. Clin Trials. 2005;2:295–300discussion 1–4, 64–78
  16. Berry DA. Bayesian clinical trials. Nat Rev Drug Discov. 2006;5:27–36
  17. Malec D, Sedransk J. Bayesian predictive inference for units with small sample sizes. The case of binary random variables. Med Care. 1993;31(5 Suppl):YS66–YS70
  18. Xiaoyin W, He CZ, Dongchu S. Bayesian population estimation for small sample capture-recapture data using noninformative priors. J Stat Plan Inference. 2007;137:1099–1118
  19. Lewis RJ, Wears RL. An introduction to the Bayesian analysis of clinical trials. Ann Emerg Med. 1993;22:1328–1336
  20. Campbell G. The experience in the FDA's Center for Devices and Radiological Health with Bayesian strategies. Clin Trials. 2005;2:359–363discussion 64–78
  21. U.S. Food and Drug Administration. Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. Center for Devices and Radiological Health, Division of Biostatistics, Office of Surveillance and Biometrics. Rockville,MD. February 5, 2010. Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071121.pdf
  22. Spiegelhalter DJ, Myles JP, Jones DR, Abrams KR. Bayesian methods in health technology assessment: a review. Health Technol Assess. 2000;4(38):1–130
  23. The BaSiS Group . Bayesian standards in science (BaSiS). Available at http://lib.stat.cmu.edu/bayesworkshop/2001/BaSis.html2001;
  24. Sung L, Hayden J, Greenberg ML, Koren G, Feldman BM, Tomlinson GA. Seven items were identified for inclusion when reporting a Bayesian analysis of a clinical study. J Clin Epidemiol. 2005;58:261–268
  25. Lipscomb B, Ma G, Berry DA. Bayesian predictions of final outcomes: regulatory approval of a spinal implant. Clin Trials. 2005;2:325–333discussion 34–39, 64–78
  26. Babapulle MN, Joseph L, Belisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet. 2004;364:583–591
  27. Brophy JM, Belisle P, Joseph L. Evidence for use of coronary stents. A hierarchical Bayesian meta-analysis. Ann Intern Med. 2003;138:777–786
  28. Grines CL, Nelson TR, Safian RD, Hanzel G, Goldstein JA, Dixon S. A Bayesian meta-analysis comparing AngioJet thrombectomy to percutaneous coronary intervention alone in acute myocardial infarction. J Interv Cardiol. 2008;21:459–482
  29. Lam SK, Owen A. Combined resynchronisation and implantable defibrillator therapy in left ventricular dysfunction: Bayesian network meta-analysis of randomised controlled trials. BMJ. 2007;335:925
  30. Walsh SR, Boyle JR, Lynch AG, Sadat U, Carpenter JP, Tang TY, et al. Suprarenal endograft fixation and medium-term renal function: systematic review and meta-analysis. J Vasc Surg. 2008;47:1364–1370
  31. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P000028). AFFINITY Anterior Cervical Cage System. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P000028b.pdfJune 13, 2002;
  32. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P000053). AMS Sphincter 800 Urinary Prosthesis. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P000053b.pdfJune 14, 2001;
  33. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P980048). BAK/Cervical Interbody Fusion System. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P980048b.pdfApril 20, 2001;
  34. U.S. Food and Drug Administration. Summary of safety and effectiveness (P080007). Bard E-LUMINEXX Vascular Stent. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080007b.pdfDecember 4, 2008;
  35. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P060023). BRYAN Cervical Disc. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060023b.pdfJuly 17, 2009;
  36. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P000036). DERMAGRAFT. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P000036b.pdfSeptember 28, 2001;
  37. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P040021). Epic Valve. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040021b.pdfNovember 15, 2007;
  38. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P020014). Essure System. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014b.pdfNovember 4, 2002;
  39. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P000058). InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdfJuly 2, 2002;
  40. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P970015). Intervertebral body fusion device, INTER FIX Threated Fusion Device. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P970015b.pdfMay 14, 1999;
  41. FDA-Prestige  U.S. Food and Drug Administration. Summary of safety and effectiveness data (P060018). PRESTIGE Cervical Disc System. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060018b.pdfJuly 16, 2007;
  42. U.S. Food and Drug Administration. Summary of safety and effectiveness data (P040021). SJM Biocor Valve. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040021b.pdfAugust 5, 2005;
  43. Higgins JP, Whitehead A. Borrowing strength from external trials in a meta-analysis. Stat Med. 1996;15:2733–2749
  44. Prevost TC, Abrams KR, Jones DR. Hierarchical models in generalized synthesis of evidence: an example based on studies of breast cancer screening. Stat Med. 2000;19:3359–3376
  45. Sutton AJ, Abrams KR. Bayesian methods in meta-analysis and evidence synthesis. Stat Methods Med Res. 2001;10:277–303
  46. Sutton AJ, Abrams KR, Jones DR, Sheldon TA, Song F. Systematic reviews of trials and other studies. Health Technol Assess. 1998;2(19):1–276
  47. Wijeysundera DN, Austin PC, Hux JE, Beattie WS, Laupacis A. Bayesian statistical inference enhances the interpretation of contemporary randomized controlled trials. J Clin Epidemiol. 2009;62:13–21e5
  48. Fisher LD. Comments on Bayesian and frequentist analysis and interpretation of clinical trials. Control Clin Trials. 1996;17:423–434
  49. Parmar MK, Spiegelhalter DJ, Freedman LS. The CHART trials: Bayesian design and monitoring in practice. CHART Steering Committee. Stat Med. 1994;13:1297–1312
  50. Lilford RJ. Ethics of clinical trials from a Bayesian and decision analytic perspective: whose equipoise is it anyway?. BMJ. 2003;326:980–981
  51. Lilford RJ, Jackson J. Equipoise and the ethics of randomization. J R Soc Med. 1995;88:552–559
  52. Cowles MD, Carlin BP. Markov Chain Monte Carlo convergence diagnostics: a comparative review. J Am Stat Assoc. 1996;91:883–904
  53. Van Dongen S. Prior specification in Bayesian statistics: three cautionary tales. J Theor Biol. 2006;242:90–100

PII: S0895-4356(10)00185-X

doi: 10.1016/j.jclinepi.2010.03.018

Journal of Clinical Epidemiology
Volume 64, Issue 3 , Pages 270-279 , March 2011