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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.

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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

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Research in Healthcare Epidemiology and Antimicrobial Stewardship (HE&AS) is rapidly expanding with the involvement of researchers from varied countries and backgrounds. Researchers must use scientific methods that will provide the strongest evidence to advance healthcare epidemiology, but there are limited resources for information on specific aspects of HE&AS research or easy ways to access examples of studies using specific methods with HE&AS. In response to this need, the SHEA Research Committee has developed a series of white papers on research methods in HE&AS. The objective of this series is to promote rigorous healthcare epidemiology research by summarizing critical components, practical considerations, and pitfalls of commonly used research methods.

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The scope of a healthcare institution’s infection prevention and control/healthcare epidemiology program (IPC/HE) should be driven by the size and complexity of the patient population served, that population’s risk for healthcare-associated infection (HAI), and local, state, and national regulatory and accreditation requirements. Essential activities of all IPC/HE programs are reviewed in this white paper.

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Since its inception in the 1960s, the specialty of infection prevention and control has grown considerably. The field took shape in the 1970s following the landmark Study on the Efficacy of Nosocomial Infection Control (SENIC) project and grew in importance with the emergence of employee safety and multidrug-resistant  organisms in the 1980s.1,2 In the 1990s and into the 2000s, the focus on hospital-acquired infection (HAI) prevention grew, so the field played a larger role in regulatory, patient safety, and quality improvement issues. In the present day, infection control data are frequently available to the public and impact hospital finances and healthcare insurance reimbursements.

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Antimicrobial stewardship (AS) refers to coordinated interventions to improve and measure the appropriate use of antimicrobials by promoting the selection of the optimal antimicrobial drug regimen, dose, duration of therapy and route of administration. The objectives of antimicrobial stewardship are to achieve the best clinical outcomes related to antimicrobial use while minimizing emergence of antimicrobial resistant organisms, Clostridium difficile infection, and other adverse events and reducing excessive costs attributable to suboptimal antimicrobial use.

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A framework for achieving elimination of HAIs using successful preventive practices and public health strategies to achieve the goal of eliminating HAIs builds upon the basis of lessons from recent successes and require constant action and vigilance. These are: implement evidence-based practices that protect patients; align incentives to promote system-wide strategies for HAI prevention; address gaps in knowledge to push beyond the current medical knowledge; and collect data to target prevention efforts and to measure progress.

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In large part, the discussion about the rationale for influenza vaccination of healthcare personnel, the strategies designed to improve influenza vaccination rates in this population, and the recommendations made in the 2005 paper still stand. This position paper notes new evidence released since publication of the 2005 paper and strengthens SHEA’s position on the importance of influenza vaccination of HCP. This document does not discuss vaccine allocation during times of vaccine shortage, because the 2005 SHEA Position Paper still serves as the society’s official statement on that issue. SHEA views influenza vaccination of HCP as a core patient and HCP safety practice with which noncompliance should not be tolerated. Therefore, for the safety of both patients and HCP, SHEA endorses a policy in which annual influenza vaccination is a condition of both initial and continued HCP employment and/or professional privileges.

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Revised: August 2010, ICHE

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The emergence of a novel H1N1 influenza A virus has dramatically impacted communities and healthcare institutions across the globe. In addition to potential exposure in the community, healthcare personnel are often called upon to care for individuals with suspected or confirmed novel H1N1 influenza A and may become exposed to the virus if appropriate infection control precautions are not implemented.

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This document describes useful and practical metrics and surveillance considerations for measuring MDROs and the infections they cause in the practice of infection prevention and control in healthcare settings. These metrics are designed to aid healthcare workers in documenting trends over time within their facility and should not be used for interfacility comparison.The following MDROs are addressed: (1) methicillin‐resistant Staphylococcus aureus; (2) vancomycin‐resistant Enterococcus species; (3) multidrug‐resistant gram‐negative bacilli; and (4) vancomycin‐resistant S. aureus. We convened a working group of experts that reviewed current practices, the peer‐reviewed literature, and existing guidelines on surveillance strategies and key metrics.

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The SHEA Board of Directors appointed a task force to draft this evidence‐based guideline to assist hospital epidemiologists in justifying and expanding their programs. Part 1 describes the basic steps needed to complete a business‐case analysis for an individual institution. A case study based on a representative infection control intervention is provided. Part 2 reviews important basic economic concepts and describes approaches that can be used to assess the financial impact of infection prevention, surveillance, and control interventions, as well as the attributable costs of specific healthcare‐associated infections. Both parts of the guideline aim to provide the hospital epidemiologist, infection control professional, administrator, and researcher with the tools necessary to complete a thorough business‐case analysis and to undertake an outcome study of a nosocomial infection or an infection control intervention.

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SHEA established a consensus panel to develop recommendations for optimal infrastructure and essential activities of infection control and epidemiology programs in hospitals. The following report represents the consensus panel's best assessment of needs for a healthy and effective hospital-based infection control and epidemiology program. The recommendations fall into eight categories: managing critical data and information; setting and recommending policies and procedures; compliance with regulations, guidelines, and accreditation requirements; employee health; direct intervention to prevent transmission of infectious diseases; education and training of healthcare workers; personnel resources; and nonpersonnel resources. The consensus panel used an evidence-based approach and categorized recommendations according to modifications of the scheme developed by IDSA and HICPAC.

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Strain typing is an integral part of epidemiological investigations of nosocomial infections. Although not all molecular techniques are equally effective for typing all organisms, pulsed-field gel electrophoresis is the technique currently favored for most nosocomial pathogens. Nucleic acid amplification-based typing methods also are applicable to many organisms and can be completed within a single day, but interpretive criteria still are under debate. Strain typing cannot be used to replace a sound epidemiological investigation, but serves as a useful adjunct to such investigations.

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The Quality Indicator Study Group was created by the governing boards of three national professional organizations that have interest and experience in epidemiology, nosocomial infection control and prevention, and quality of care improvement. The Study Group has reviewed the existing literature concerning quality indicators, interviewed experts in the field, and focused on how best to evaluate such indicators, with an emphasis on nosocomial infection indicators as a paradigm for all QIs. In this report, we review pertinent issues and, where possible, provide specific advice on how to evaluate QIs and QI systems.

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