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

  • Deverick J. Anderson (a1), Manisha Juthani-Mehta (a2) and Daniel J. Morgan (a3)
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

Copyright
Corresponding author
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 (dja@duke.edu).
References
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1. IoannidisJP, HaidichAB, PappaM, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 2001;286:821830.
2. FriedmanLM, FurbergCD, DeMetsDL. Fundamentals of Clinical Trials, 3rd ed. New York, NY, USA: Springer, 1998.
3. EldridgeS, KerryS. A Practical Guide to Cluster Randomised Trials in Health Services Research. Wiley; 2012.
4. MeurerWJ, LewisRJ. Cluster randomized trials: evaluating treatments applied to groups. JAMA 2015;313:20682069.
5. CampbellMK, ElbourneDR, AltmanDG. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702708.
6. DansAL, DansLF, GuyattGH, RichardsonS. 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.
7. BailyMA. Harming through protection? New Engl J Med 2008;358:768769.
8. PronovostP, NeedhamD, BerenholtzS, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. New Engl J Med 2006;355:27252732.
9. EvansSR, RubinD, FollmannD, et al. Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR). Clin Infect Dis 2015;61:800806.
10. Van NessPH, PeduzziPN, QuagliarelloVJ. 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.
11. LoebM, DafoeN, MahonyJ, et al. Surgical mask vs N95 respirator for preventing influenza among health care workers: a randomized trial. JAMA 2009;302:18651871.
12. DarouicheRO, WallMJJr, ItaniKM, et al. Chlorhexidine-alcohol versus povidone-iodine for surgical-site antisepsis. New Engl J Med 2010;362:1826.
13. TimsitJF, SchwebelC, BouadmaL, 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.
14. PickardR, LamT, MacLennanG, 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.
15. ModyL, KreinSL, SaintS, et al. A targeted infection prevention intervention in nursing home residents with indwelling devices: a randomized clinical trial. JAMA Intern Med 2015;175:714723.
16. SalgadoCD, SepkowitzKA, JohnJF, et al. Copper surfaces reduce the rate of healthcare-acquired infections in the intensive care unit. Infect Control Hosp Epidemiol 2013;34:479486.
17. ClimoMW, YokoeDS, WarrenDK, et al. Effect of daily chlorhexidine bathing on hospital-acquired infection. New Engl J Med 2013;368:533542.
18. HuangSS, SeptimusE, KleinmanK, et al. Targeted versus universal decolonization to prevent ICU infection. New Engl J Med 2013;368:22552265.
19. MilstoneAM, ElwardA, SongX, et al. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet 2013;381:10991106.
20. NotoMJ, DomenicoHJ, ByrneDW, et al. Chlorhexidine bathing and health care-associated infections: a randomized clinical trial. JAMA 2015;313:369378.
21. DerdeLP, CooperBS, GoossensH, 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.
22. HuskinsWC, HuckabeeCM, O’GradyNP, et al. Intervention to reduce transmission of resistant bacteria in intensive care. New Engl J Med 2011;364:14071418.
23. HarrisAD, PinelesL, BeltonB, et al. Universal glove and gown use and acquisition of antibiotic-resistant bacteria in the ICU: a randomized trial. JAMA 2013;310:15711580.
24. BelliniC, PetignatC, MassereyE, 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.
25. Juthani-MehtaM, Van NessPH, McGloinJ, 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.
26. GerberJS, PrasadPA, FiksAG, 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.
27. MeekerD, KnightTK, FriedbergMW, et al. Nudging guideline-concordant antibiotic prescribing: a randomized clinical trial. JAMA Intern Med 2014;174:425431.
28. FullerC, MichieS, SavageJ, 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.
29. PassarettiCL, OtterJA, ReichNG, 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.
30. StevensonKB, SearleK, CurryG, 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.
31. HautER, PronovostPJ. Surveillance bias in outcomes reporting. JAMA 2011;305:24622463.
32. YoungH, KnepperB, MooreEE, JohnsonJL, MehlerP, PriceCS. 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.
33. BodeLG, KluytmansJA, WertheimHF, et al. Preventing surgical-site infections in nasal carriers of Staphylococcus aureus . New Engl J Med 2010;362:917.
34. MoherD, SchulzKF, AltmanDG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001;357:11911194.
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Infection Control & Hospital Epidemiology
  • ISSN: 0899-823X
  • EISSN: 1559-6834
  • URL: /core/journals/infection-control-and-hospital-epidemiology
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