Randomized Cluster Crossover Trials for Reliable, Efficient, Comparative Effectiveness Testing: Design of the Prevention of Arrhythmia Device Infection Trial (PADIT)

Canadian Journal of Cardiology

Volumn 29, Issue 6, 2013, Pages 652-658

  Connolly, Stuart J ^a   Philippon, Francois ^b   Longtin, Yves ^c   Casanova, Amparo ^a   Birnie, David H ^c   Exner, Derek V ^d   Dorian, Paul ^e   Prakash, Ratika ^f   Alings, Marco ^g   Krahn, Andrew D ^h  

^a MCMASTER UNIVERSITY   (Canada)

^b LAVAL UNIVERSITY   (Canada)

^c UNIVERSITY OF OTTAWA HEART INSTITUTE   (Canada)

^d UNIVERSITY OF CALGARY   (Canada)

^e UNIVERSITY OF TORONTO   (Canada)

^f DALHOUSIE UNIVERSITY   (Canada)

^g Working Group on Cardiovascular Research the Netherlands   (Netherlands)

^h UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; CEFAZOLIN; CLINDAMYCIN; VANCOMYCIN;

ANTIBIOTIC PROPHYLAXIS; ANTIBIOTIC THERAPY; ARTICLE; CARDIAC RESYNCHRONIZATION THERAPY DEVICE; CLINICAL EFFECTIVENESS; CLUSTER ANALYSIS; COMPARATIVE EFFECTIVENESS; DEVICE INFECTION; HUMAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; INFECTION PREVENTION; PACEMAKER; PILOT STUDY; RELIABILITY;

ANTI-BACTERIAL AGENTS; ARRHYTHMIAS, CARDIAC; CANADA; CLUSTER ANALYSIS; CROSS-OVER STUDIES; DEFIBRILLATORS, IMPLANTABLE; DEVICE REMOVAL; EQUIPMENT CONTAMINATION; HUMANS; PACEMAKER, ARTIFICIAL; PROSTHESIS-RELATED INFECTIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84878123217     PISSN: 0828282X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cjca.2013.01.020     Document Type: Article

References (33)

1. Platt R., Tavorkian S.U., Septimus E., et al. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections. Med Care 2010, 48:S52-S57.
2. Gould P.A., Krahn A.D. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 2006, 295:1907-1911.
3. Mela T., McGovern B.A., Garan H., et al. Long-term infection rates associated with the pectoral versus abdominal approach to cardioverter-defibrillator implants. Am J Cardiol 2001, 88:750-753.
4. de Oliveira J.C., Martinelli M., Nishioka S.A., et al. Efficacy of antibiotic prophylaxis before the implantation of pacemakers and cardioverter-defibrillators: results of a large, prospective, randomized, double-blinded, placebo-controlled trial. Circ Arrhythm Electrophysiol 2009, 2:29-34.
5. Klug D., Balde M., Pavin D., et al. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation 2007, 116:1349-1355.
6. Sohail M.R., Uslan D.Z., Khan A.H., et al. Management and outcome of permanent pacemaker and implantable cardioverter-defibrillator infections. J Am Coll Cardiol 2007, 49:1851-1859.
7. Sohail M.R., Uslan D.Z., Khan A.H., et al. Risk factor analysis of permanent pacemaker infection. Clin Infect Dis 2007, 45:166-173.
8. Greenspon A.J., Patel J.D., Lau E., et al. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States. J Am Coll Cardiol 2011, 58:1001-1006.
9. Paulin F.L., Gula L.J., Yee R., Skanes A.C., Klein G.J., Krahn A.D. Management of infections involving implanted cardiac electrophysiologic devices. Curr Treat Options Cardiovasc Med 2008, 10:380-387.
10. Gula L.J., Krahn A.D., Yee R., Skanes A.C., Ghosh N., Klein G.J. Arrhythmia device lead extraction: factors that necessitate laser assistance. Can J Cardiol 2008, 24:767-770.
11. Kapa S., Hyberger L., Rea R.F., Hayes D.L. Complication risk with pulse generator change: implications when reacting to a device advisory or recall. Pacing Clin Electrophysiol 2007, 30:730-733.
12. Byrd C.L. Managing device-related complications and transvenous lead extraction. Clinical Cardiac Pacing, Defibrillation, and Resynchronization Therapy 2007, 855-930. Saunders, Philadelphia. 3rd Ed. K.A. Ellenbogen, G.N. Kay, B.L. Wilkoff, C.P. Lau (Eds.).
13. Da Costa A., Kirkorian G., Cucherat M., et al. Antibiotic prophylaxis for permanent pacemaker implantation: a meta-analysis. Circulation 1998, 97:1796-1801.
14. Epstein A.E., DiMarco J.P., Ellenbogen K.A., et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol 2008, 51:e1-62.
15. Sohail M.R., Uslan D.Z., Khan A.H., et al. Infective endocarditis complicating permanent pacemaker and implantable cardioverter-defibrillator infection. Mayo Clin Proc 2008, 83:46-53.
16. Greenspon A.J., Rhim E.S., Mark G., Desimone J., Ho R.T. Lead-associated endocarditis: the important role of methicillin-resistant staphylococcus aureus. Pacing Clin Electrophysiol 2008, 31:548-553.
17. Antimicrobial prophylaxis for surgery. Treat Guidel Med Lett 2009, 7:47-52.
18. Bratzler D.W., Houck P.M. Antimicrobial prophylaxis for surgery: an advisory statement from the national surgical infection prevention project. Clin Infect Dis 2004, 38:1706-1715.
19. Edwards F.H., Engelman R.M., Houck P., Shahian D.M., Bridges C.R. The society of thoracic surgeons practice guideline series: antibiotic prophylaxis in cardiac surgery, part I: duration. Ann Thorac Surg 2006, 81:397-404. Society of Thoracic Surgeons.
20. Cairns J.A., Yusuf S., Cook R.J., et al. Canadian network and centre for trials internationally (CANNeCTIN): a national network for Canadian-led trials in cardiovascular diseases and diabetes mellitus. Can J Cardiol 2010, 26:353-358.
21. McRae A.D., Weijer C., Binik A., et al. When is informed consent required in cluster randomized trials in health research?. Trials 2011, 12:202.
22. McRae A.D., Weijer C., Binik A., et al. Who is the research subject in cluster randomized trials in health research?. Trials 2011, 12:183.
23. Binik A., Weijer C., McRae A.D., et al. Does clinical equipoise apply to cluster randomized trials in health research?. Trials 2011, 12:118.
24. Taljaard M., Weijer C., Grimshaw J.M., et al. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. Trials 2009, 10:61.
25. Klar N., Donner A. Current and future challenges in the design and analysis of cluster randomization trials. Stat Med 2001, 20:3729-3740.
26. Turner R.M., White I.R., Croudace T. Analysis of cluster randomized cross-over trial data: a comparison of methods. Stat Med 2007, 26:274-289.
27. Donner A., Klar N., Guangyong Z. Methods for the statistical analysis of binary data in split-cluster designs. Biometrics 2004, 60:919-925.
28. Giraudeau B., Ravaud P., Donner A. Sample size calculation for cluster randomized cross-over trials [Erratum in 2009;28:720]. Stat Med 2008, 27:5578-5585.
29. Thompson S.G., Pyke S.D., Hardy R.J. The design and analysis of paired cluster randomized trials: an application of meta-analysis techniques. Stat Med 1997, 16:2063-2079.
30. Weijer C., Grimshaw J.M., Taljaard M., et al. Ethical issues posed by cluster randomized trials in health research. Trials 2011, 12:100.
31. Department of Health and Human Services. Protection of human subjects. Available at: Accessed April 5, 2013. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
32. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council. Tri-council policy statement. Ethical conduct for research involving humans. Available at: Accessed July 24, 2011. http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf.
33. Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International ethical guidelines for biomedical research involving human subjects. Available at: April 5, 2013. http://www.cioms.ch/publications/layout_guide2002.pdf.