Hostname: page-component-78c5997874-4rdpn Total loading time: 0 Render date: 2024-11-13T01:01:03.598Z Has data issue: false hasContentIssue false

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship—Observational Studies

Published online by Cambridge University Press:  20 June 2016

Graham M. Snyder*
Affiliation:
Beth Israel Deaconess Medical Center, Harvard University, Boston, Massachusetts
Heather Young
Affiliation:
Denver Health Medical Center, University of Colorado Hospital, Denver, Colorado
Meera Varman
Affiliation:
Creighton University School of Medicine, Omaha, Nebraska
Aaron M. Milstone
Affiliation:
Johns Hopkins Medical Institutions, Baltimore, Maryland
Anthony D. Harris
Affiliation:
University of Maryland School of Medicine, Veterans Affairs Maryland Health Care System, Baltimore, Maryland
Silvia Munoz-Price
Affiliation:
Institute for Health and Society and Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin
*
Address correspondence to Graham Snyder, Mailstop SL-435, 330 Brookline Ave, Boston, MA 02215 (gsnyder@bidmc.harvard.edu).

Abstract

Observational studies compare outcomes among subjects with and without an exposure of interest, without intervention from study investigators. Observational studies can be designed as a prospective or retrospective cohort study or as a case-control study. In healthcare epidemiology, these observational studies often take advantage of existing healthcare databases, making them more cost-effective than clinical trials and allowing analyses of rare outcomes. This paper addresses the importance of selecting a well-defined study population, highlights key considerations for study design, and offers potential solutions including biostatistical tools that are applicable to observational study designs.

Infect Control Hosp Epidemiol 2016;1–6

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. von Elm, E, Altman, DG, Egger, M, Pocock, SJ, Gotzsche, PC, Vandenbroucke, JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 2007;147:573577.Google Scholar
2. Sanderson, S, Tatt, ID, Higgins, JP. Tools for assessing quality and susceptibility to bias in observational studies in epidemiology: a systematic review and annotated bibliography. Int J Epidemiol 2007;36:666676.Google Scholar
3. Hofler, M. Causal inference based on counterfactuals. BMC Med Res Methodol 2005;5:28.Google Scholar
4. Kleinbaum, DG, Kupper, LL, Morgenstern, H. Epidemiologic Research: Principles and Quantitative Methods. Belmont, CA: Lifetime Learning Publications; 1982.Google Scholar
5. Schulz, KF, Grimes, DA. Case-control studies: research in reverse. Lancet 2002;359:431434.Google Scholar
6. Wacholder, S, McLaughlin, JK, Silverman, DT, Mandel, JS. Selection of controls in case-control studies. I. Principles. Am J Epidemiol 1992;135:10191028.Google Scholar
7. Wacholder, S, Silverman, DT, McLaughlin, JK, Mandel, JS. Selection of controls in case-control studies. III. Design options. Am J Epidemiol 1992;135:10421050.Google Scholar
8. Wyllie, D, Davies, J. Role of data warehousing in healthcare epidemiology. J Hosp Infect 2015;89:267270.Google Scholar
9. Harris, AD, Carmeli, Y, Samore, MH, Kaye, KS, Perencevich, E. Impact of severity of illness bias and control group misclassification bias in case-control studies of antimicrobial-resistant organisms. Infect Control Hosp Epidemiol 2005;26:342345.Google Scholar
10. Dhar, S, Tansek, R, Toftey, EA, et al. Observer bias in hand hygiene compliance reporting. Infect Control Hosp Epidemiol 2010;31:869870.Google Scholar
11. Nelson, RE, Nelson, SD, Khader, K, et al. The magnitude of time-dependent bias in the estimation of excess length of stay attributable to healthcare-associated infections. Infect Control Hosp Epidemiol 2015;36:10891094.Google Scholar
12. Schweizer, ML, Braun, BI, Milstone, AM. Research methods in healthcare epidemiology and antimicrobial stewardship—quasi-experimental designs. Infect Control Hosp Epidemiol DOI: http://dx.doi.org/10.1017/ice.2016.91. Published online April 14, 2016.Google Scholar
13. Rhame, FS, Sudderth, WD. Incidence and prevalence as used in the analysis of the occurrence of nosocomial infections. Am J Epidemiol 1981;113:111.Google Scholar
14. Viera, AJ, Garrett, JM. Understanding interobserver agreement: the kappa statistic. Fam Med 2005;37:360363.Google Scholar
15. Hallgren, KA. Computing inter-rater reliability for observational data: an overview and tutorial. Tutor Quant Methods Psychol 2012;8:2334.Google Scholar
16. 2014 NHSN Data Quality Guidance and Toolkit for Reporting Facilities: Internal Validation of NHSN Patient Safety Component Data. Centers for Disease Control and Prevention website. http://www.cdc.gov/nhsn/validation/index.html. Published 2014. Accessed January 29, 2016.Google Scholar
17. Piroth, L, Aube, H, Doise, JM, Vincent-Martin, M. Spread of extended-spectrum beta-lactamase-producing Klebsiella pneumoniae: are beta-lactamase inhibitors of therapeutic value? Clin Infect Dis 1998;27:7680.Google Scholar
18. Harris, AD, Karchmer, TB, Carmeli, Y, Samore, MH. Methodological principles of case-control studies that analyzed risk factors for antibiotic resistance: a systematic review. Clin Infect Dis 2001;32:10551061.CrossRefGoogle ScholarPubMed
19. Ong, DS, Jongerden, IP, Buiting, AG, et al. Antibiotic exposure and resistance development in Pseudomonas aeruginosa and Enterobacter species in intensive care units. Crit Care Med 2011;39:24582463.CrossRefGoogle ScholarPubMed
20. Wirtschafter, DD, Powers, RJ, Pettit, JS, et al. Nosocomial infection reduction in VLBW infants with a statewide quality-improvement model. Pediatrics 2011;127:419426.Google Scholar
21. Petticrew, M, Cummins, S, Ferrell, C, et al. Natural experiments: an underused tool for public health? Public Health 2005;119:751757.Google Scholar
22. Davies, HT, Crombie, IK, Tavakoli, M. When can odds ratios mislead? BMJ 1998;316:989991.Google Scholar
23. Newgard, CD, Lewis, RJ. Missing data: how to best account for what is not known. JAMA 2015;314:940941.Google Scholar
24. Muscedere, JG, Day, A, Heyland, DK. Mortality, attributable mortality, and clinical events as end points for clinical trials of ventilator-associated pneumonia and hospital-acquired pneumonia. Clin Infect Dis 2010;51(Suppl 1):S120S125.CrossRefGoogle ScholarPubMed
25. Schumacher, M, Allignol, A, Beyersmann, J, Binder, N, Wolkewitz, M. Hospital-acquired infections—appropriate statistical treatment is urgently needed! Int J Epidemiol 2013;42:15021508.Google Scholar
26. Austin, PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res 2011;46:399424.Google Scholar