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To date, only 1 statewide prevalence survey has been performed for Acinetobacter baumannii (2009) in the US, and no statewide prevalence survey has been performed for Candida auris, making the current burden of these emerging pathogens unknown.
Cluster randomized control trials (CRCTs) are used frequently in the field of infection control and antimicrobial stewardship because randomization at the patient level is often not feasible due to contamination, ethical, or logistical issues. The correlation and thus non-independence that exists among individual patients in a cluster must be accounted for when estimating sample size for such trials, yet many studies neglect to consider or report the intracluster correlation coefficient (ICC) and the resulting coefficient of variation (CV) in rates between hospitals. The aim of this study was to estimate the sample sizes needed to adequately power studies of hospital-level interventions to reduce rates of healthcare-associated infections. We calculated the minimum number of clusters or hospitals that would need to be included in a study to have good power to detect an impact of the intervention given a range of different assumptions. We estimated parameters needed for these calculations using national rates from the National Healthcare Safety Network (NHSN) for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia, central-line associated bloodstream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), C. difficile infections (CDI) and variation between hospitals in these rates. These calculations were based on the assumption that hospitals were uniform and moderate in size and were studied for 1 year. To study an intervention leading to a 50% decrease in daily rates and using the C vs. calculated from NHSN, 22 average-sized hospitals for MRSA bacteremia are needed, 34 for CAUTI, 9 for CDI, and 27 for CLABSI to have a statistically significant decrease with a type I error rate of 0.05 and a type II error rate of 0.8. If a 10% decrease in rates is expected instead, 709, 1205, 279, and 866 hospitals, respectively, are needed. Sample size estimates for CRCTs are most influenced by the CV and the expected effect size. Given the large sample size requirements, it is likely that many CRCTs in hospital epidemiology are under-powered. We hope that these findings lead to more definitive CRCTs in the field of hospital epidemiology that are properly powered and more studies reporting their ICC or CV. All authors: No reported disclosures.
Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.
Abstract Background The optimal approach to using contact precautions for patients known to be colonized or infected with MRSA remains unclear despite knowledge that transmission risk varies by healthcare personnel role and care activity being performed. Additionally, the patient perspective is not routinely represented in infection control policies. The aim of this study was to assess patient perspectives on risk-based application of MRSA contact precautions in VA hospitals. Methods We conducted an in-person 75-minute focus group with seven Veteran patients colonized with MRSA. The session was audio recorded and transcribed verbatim. We developed a codebook based on the interview guide and used Nvivo 9 for analysis. One research team member coded the transcripts. Thematic analysis was utilized to summarize the findings. Emergent themes and patterns were identified by initial inductive analysis and themes were condensed into overarching categories. Results All patients agreed that they would prefer if healthcare workers wore gloves and a gown the entire time when providing care to all patients with MRSA. As shown in Table 1, participants identified three themes related to perceived advantages to the use of contact precautions for all care of patients with MRSA. The most frequently mentioned advantage was that doing so aligns with the premise that protecting patients and making them feel safe while in hospital should be the top priority. Participants also acknowledged five themes describing disadvantages to contact precautions such as the environmental impact and cost but stressed that these disadvantages should not be used to rationalize provision of what they viewed as suboptimal care. Most participants were open to a risk-tailored approach instead of total removal of all contact although some articulated concerns this may make patients may feel less safe and feel like they are not being treated equally. Conclusion These qualitative findings suggest that Veteran patients with MRSA support the use of contact precautions and are willing to consider a risk-tailored approach to glove and gown use if this is accompanied by education for healthcare personnel, patients, and families. Disclosures Anthony Harris, MD, MPH, Innoviva: Advisor/Consultant|UpToDate: Infection Control Editor
Abstract Background The risk of MRSA transmission differs by healthcare personnel (HCP) role and care activity. An alternative to an “all or none” approach to contact precautions for patients with MRSA carriage is a “risk-tailored” approach – using gloves and gowns only for certain high-risk activities, locations, or roles. A discrete choice experiment is a proven method to assess HCP perspectives on varied implementation strategies. Methods We distributed a discrete choice experiment survey to HCPs at medical centers in three cities. Respondents were presented with eight choice sets, each consisting of two hypothetical policy options for glove and gown use to prevent MRSA transmission (Fig 1). In each comparison, respondents selected their preferred policy option. Using mixed logit modeling we calculated the utility derived from each policy component, the probability of uptake for the most favored policies, and heterogeneity in preferences based on HCP role. Results 384 HCP completed the survey: 138 from New York, 128 from Pittsburgh, and 118 from Baltimore. Respondents’ occupations were physicians or advanced practice providers (93, 24%), nurses (87, 23%), environmental services (56, 15%), respiratory therapists (55, 14%), occupational or physical therapists (44, 11%), and “other” (46, 11%). 237 (54%) respondents reported wearing gloves and gowns ‘all the time’ when required. Respondents preferred policy with the highest utility score was to use gloves and gown for all HCPs roles (utility, 0.17; 95% CI, 0.12 to 0.23), in high-risk settings (utility, 0.12; 95% CI 0.07-0.18), when touching the patient (utility, 0.11; 95% CI 0.06-0.17) (Fig 2). Sixty-three percent (95% CI 60-66%) of respondents would support a risk-tailored approach over an approach where contact precautions are used by all HCP in all settings and for all activities. The support for this policy varied by HCP role (p< 0.02), with the strongest probability of support from physicians and advanced practice providers (77%, 95% CI 72-82%) and the least support from environmental services (45%, 95% CI 37-53%) (Fig 3). Conclusion This discrete choice survey demonstrates that most HCP prefer a risk-tailored approach to contact precautions when caring for patients with MRSA. Disclosures Anthony Harris, MD, MPH, Innoviva: Advisor/Consultant|UpToDate: Infection Control Editor Graham M. Snyder, MD, SM, Infectious Diseases Connect: Advisor/Consultant Nathan N. O'Hara, PhD MHA, Arbutus Medical Inc.: Stocks/Bonds (Private Company)
BackgroundCommunity-based cluster-randomized controlled trials (RCTs) are increasingly being conducted to address pressing global health concerns. Preparations for clinical trials are well-described, as are the steps for multi-component health service trials. However, guidance is lacking for addressing the ethical and logistic challenges in (cluster) RCTs of population health interventions in low- and middle-income countries.ObjectiveWe aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North–South partnerships.DesignWe reviewed our experiences and identified key ethical and logistic issues encountered during the pre-trial phase of a recently implemented RCT. This trial aimed to improve tuberculosis (TB) and Human Immunodeficiency Virus (HIV) prevention and care for health workers by enhancing workplace assessment capability, addressing concerns about confidentiality and stigma, and providing onsite counseling, testing, and treatment. An iterative framework was used to synthesize this analysis with lessons taken from other studies.ResultsThe checklist of critical factors was grouped into eight categories: 1) Building trust and shared ownership; 2) Conducting feasibility studies throughout the process; 3) Building capacity; 4) Creating an appropriate information system; 5) Conducting pilot studies; 6) Securing stakeholder support, with a view to scale-up; 7) Continuously refining methodological rigor; and 8) Explicitly addressing all ethical issues both at the start and continuously as they arise.ConclusionResearchers should allow for the significant investment of time and resources required for successful implementation of population health RCTs within North–South collaborations, recognize the iterative nature of the process, and be prepared to revise protocols as challenges emerge.
The purpose of this study is to determine if lateral patient position during femoral nailing is associated with increases in intensive care unit (ICU) length of stay (LOS) or ventilator days when compared with femoral nailing in a supine position.Retrospective cohort study.Level 1 trauma center.Patients with femoral shaft fractures treated with intramedullary fixation were identified. Propensity matching was performed to minimize selection bias using factors thought to be associated with surgeon selection of supine nailing at our institution (Injury Severity Score, Abbreviated Injury Score brain, and bilateral fractures). After matching, 848 patients were included in the analysis.Femoral nailing in the lateral position compared with the supine position.Our primary outcome measure was ICU LOS. Ventilator days were the secondary outcome.Treating patients with femoral nailing in the lateral position was associated with a 1.88 days (95% confidence interval, 0.73-3.02; P = 0.001) reduction in ICU LOS in our adjusted model. Intramedullary nailing in the lateral position was associated with a 1.29 days (95% confidence interval, -0.12 to 2.69) decrease in postoperative time on a ventilator. However, this finding was not statistically significant (P = 0.07).Lateral femoral nailing was associated with decreased ICU LOS (P = 0.001) even after accounting for selection bias using propensity score matching. Our data indicate that lateral femoral nailing is likely not associated with the increased risk of pulmonary complication.Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
