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Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship: Randomized Controlled Trials

Published online by Cambridge University Press:  25 April 2016

Deverick J. Anderson*
Affiliation:
Duke University Medical Center, Division of Infectious Diseases, Durham, North Carolina
Manisha Juthani-Mehta
Affiliation:
Yale University School of Medicine, Department of Internal Medicine, Section of Infectious Diseases, New Haven, Connecticut
Daniel J. Morgan
Affiliation:
VA Maryland Healthcare System and University of Maryland School of Medicine, Baltimore, Maryland
*
Address correspondence to Deverick J. Anderson, MD, MPH, Associate Professor of Medicine, Division of Infectious Diseases, Box 102359, Duke University Medical Center, Durham, NC 27710 ([email protected]).

Abstract

Randomized controlled trials (RCT) produce the strongest level of clinical evidence when comparing interventions. RCTs are technically difficult, costly, and require specific considerations including the use of patient- and cluster-level randomization and outcome selection. In this methods paper, we focus on key considerations for RCT methods in healthcare epidemiology and antimicrobial stewardship (HE&AS) research, including the need for cluster randomization, conduct at multiple sites, behavior modification interventions, and difficulty with identifying appropriate outcomes. We review key RCTs in HE&AS with a focus on advantages and disadvantages of methods used. A checklist is provided to aid in the development of RCTs in HE&AS.

Infect Control Hosp Epidemiol 2016;37:629–634

Type
SHEA White Paper
Copyright
© 2016 by The Society for Healthcare Epidemiology of America. All rights reserved 

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References

REFERENCES

1. Ioannidis, JP, Haidich, AB, Pappa, M, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 2001;286:821830.Google Scholar
2. Friedman, LM, Furberg, CD, DeMets, DL. Fundamentals of Clinical Trials, 3rd ed. New York, NY, USA: Springer, 1998.Google Scholar
3. Eldridge, S, Kerry, S. A Practical Guide to Cluster Randomised Trials in Health Services Research. Wiley; 2012.Google Scholar
4. Meurer, WJ, Lewis, RJ. Cluster randomized trials: evaluating treatments applied to groups. JAMA 2015;313:20682069.Google Scholar
5. Campbell, MK, Elbourne, DR, Altman, DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702708.Google Scholar
6. Dans, AL, Dans, LF, Guyatt, GH, Richardson, S. Users’ guides to the medical literature: XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group. JAMA 1998;279:545549.Google Scholar
7. Baily, MA. Harming through protection? New Engl J Med 2008;358:768769.Google Scholar
8. Pronovost, P, Needham, D, Berenholtz, S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. New Engl J Med 2006;355:27252732.Google Scholar
9. Evans, SR, Rubin, D, Follmann, D, et al. Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR). Clin Infect Dis 2015;61:800806.Google Scholar
10. Van Ness, PH, Peduzzi, PN, Quagliarello, VJ. Efficacy and effectiveness as aspects of cluster randomized trials with nursing home residents: methodological insights from a pneumonia prevention trial. Contemp Clin Trials 2012;33:11241131.Google Scholar
11. Loeb, M, Dafoe, N, Mahony, J, et al. Surgical mask vs N95 respirator for preventing influenza among health care workers: a randomized trial. JAMA 2009;302:18651871.Google Scholar
12. Darouiche, RO, Wall, MJ Jr, Itani, KM, et al. Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. New Engl J Med 2010;362:1826.Google Scholar
13. Timsit, JF, Schwebel, C, Bouadma, L, et al. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA 2009;301:12311241.Google Scholar
14. Pickard, R, Lam, T, MacLennan, G, et al. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial. Lancet 2012;380:19271935.Google Scholar
15. Mody, L, Krein, SL, Saint, S, et al. A targeted infection prevention intervention in nursing home residents with indwelling devices: a randomized clinical trial. JAMA Intern Med 2015;175:714723.Google Scholar
16. Salgado, CD, Sepkowitz, KA, John, JF, et al. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol 2013;34:479486.Google Scholar
17. Climo, MW, Yokoe, DS, Warren, DK, et al. Effect of daily chlorhexidine bathing on hospital-acquired infection. New Engl J Med 2013;368:533542.Google Scholar
18. Huang, SS, Septimus, E, Kleinman, K, et al. Targeted versus universal decolonization to prevent ICU infection. New Engl J Med 2013;368:22552265.Google Scholar
19. Milstone, AM, Elward, A, Song, X, et al. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet 2013;381:10991106.Google Scholar
20. Noto, MJ, Domenico, HJ, Byrne, DW, et al. Chlorhexidine bathing and health care-associated infections: a randomized clinical trial. JAMA 2015;313:369378.Google Scholar
21. Derde, LP, Cooper, BS, Goossens, H, et al. Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial. Lancet Infect Dis 2014;14:3139.Google Scholar
22. Huskins, WC, Huckabee, CM, O’Grady, NP, et al. Intervention to reduce transmission of resistant bacteria in intensive care. New Engl J Med 2011;364:14071418.Google Scholar
23. Harris, AD, Pineles, L, Belton, B, et al. Universal glove and gown use and acquisition of antibiotic-resistant bacteria in the ICU: a randomized trial. JAMA 2013;310:15711580.Google Scholar
24. Bellini, C, Petignat, C, Masserey, E, et al. Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study. Infect Control Hosp Epidemiol 2015;36:401408.Google Scholar
25. Juthani-Mehta, M, Van Ness, PH, McGloin, J, et al. A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis 2015;60:849857.Google Scholar
26. Gerber, JS, Prasad, PA, Fiks, AG, et al. Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians: a randomized trial. JAMA 2013;309:23452352.Google Scholar
27. Meeker, D, Knight, TK, Friedberg, MW, et al. Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial. JAMA Intern Med 2014;174:425431.Google Scholar
28. Fuller, C, Michie, S, Savage, J, et al. The Feedback Intervention Trial (FIT)—improving hand-hygiene compliance in UK healthcare workers: a stepped wedge cluster randomised controlled trial. PloS One 2012;7:e41617.Google Scholar
29. Passaretti, CL, Otter, JA, Reich, NG, et al. An evaluation of environmental decontamination with hydrogen peroxide vapor for reducing the risk of patient acquisition of multidrug-resistant organisms. Clin Infect Dis 2013;56:2735.Google Scholar
30. Stevenson, KB, Searle, K, Curry, G, et al. Infection control interventions in small rural hospitals with limited resources: results of a cluster-randomized feasibility trial. Antimicrob Resist Infect Control 2014;3:10.Google Scholar
31. Haut, ER, Pronovost, PJ. Surveillance bias in outcomes reporting. JAMA 2011;305:24622463.Google Scholar
32. Young, H, Knepper, B, Moore, EE, Johnson, JL, Mehler, P, Price, CS. Surgical site infection after colon surgery: National Healthcare Safety Network risk factors and modeled rates compared with published risk factors and rates. J Amer Coll Surg 2012;214:852859.Google Scholar
33. Bode, LG, Kluytmans, JA, Wertheim, HF, et al. Preventing surgical-site infections in nasal carriers of Staphylococcus aureus . New Engl J Med 2010;362:917.Google Scholar
34. Moher, D, Schulz, KF, Altman, DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;357:11911194.Google Scholar