Open Invention Network (United States)

Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.

BackgroundActionable, easy to interpret antibiotic use (AU) metrics provide antimicrobial stewardship programs (ASPs) with clear targets. Current aggregate AU metrics lack the ability to discriminate between long courses in a limited number of patients versus short courses in a large number of patients.MethodsWe developed a novel AU denominator termed “targeted antimicrobial use admission,” defined as an inpatient admission in which a selected agent or group of agents was administered. When used with length of therapy (LOT), it provides the average number of days patients receive the targeted agent(s) during inpatient hospital admissions. To demonstrate the added utility of this metric, we used descriptive statistics to compare it to LOT, LOT/1,000 patient days, LOT/1,000 admissions, and LOT/admission to quantify intravenous (IV) vancomycin use among 25 hospitals in the Duke Antimicrobial Stewardship Outreach Network (DASON) for calendar year 2017. The metric was also used to compare hospitals to one another and track durations at an example hospital over time.ResultsTotal LOT included 128,680 days of IV vancomycin (table). LOT/targeted antimicrobial use admission is the only metric that allows programs to quickly assess agent durations.Table:Comparison of IV Vancomycin Consumption by Metric Among 25 Hospitals in DASON, 2017LOT (days)LOT/AdmissionLOT/1,000 Patient DaysLOT/Targeted Antimicrobial Use AdmissionMean ± standard deviation5,147.2 ± 2,9940.4 ± 0.1111 ± 24.53.2 ± 0.5Median5,0930.4103.53.2Range512–13,0260.2–0.768.9–163.62.6–4.1ConclusionStewardship programs seeking to shorten durations of therapy can track this metric over time to determine the impact of their ASP efforts (Figure 1). The metric can also be used to compare average durations of IV vancomycin by hospital to determine when and if agent-focused audit and feedback or antibiotic timeouts may be useful (Figure 2). The network mean provides a target for agent-specific de-escalations, in days, for facilities with longer durations. LOT/targeted antimicrobial use admission provides an actionable metric for quantifying antimicrobial durations. This metric is easy to interpret and can feasibly be captured through the electronic prescribing record to aid in selecting ASP strategy.DisclosuresAll authors: No reported disclosures.

This study was a subset of a RCT using patient oriented discharge summaries (PODS) and looked at the caregiver impact on understanding and adherence to discharge instructions in a complex, acute medical population. An admission to hospital for acute illness can be difficult for patients and lead to high levels of anxiety. Patients are given a lot of information throughout their hospital stay and instructions at discharge to follow when they get home. For complex medical patients, the ability to retain, understand, and adhere to these instructions is a critical marker of a successful transition. This study was undertaken to explore factors impacting the ability of patients to understand and adhere to instructions. A qualitative design of interviews with patients and caregivers was used. Participants were adult patients and caregivers with congestive heart failure, chronic obstructive pulmonary disease, or community-acquired pneumonia being discharged home from three academic acute care hospitals in Ontario, Canada. Semi structured interviews were conducted with participants within one week following their discharge from hospital. Interviews were audiotaped and transcribed. Five independent researchers participated in an iterative process of coding, reviewing, and analyzing the interviews using direct content analysis. In total, 27 participants completed qualitative interviews. Analysis revealed the role of the caregiver to be critical in its relation to the ability of patients to understand and adhere to discharge instructions. Within the topic of caregiving, we draw on three areas of insight: The first clarified how caregivers support patients after they are discharged home from the hospital. The second highlighted how caregiver involvement impacts patient understanding and adherence to discharge instructions. The third revealed system factors that influence a caregiver’s involvement when receiving discharge instructions. Caregivers play an important role in the transition of a complex medical patient by impacting a patient’s ability to understand and adhere to their discharge instructions. The themes identified in this paper highlight opportunities for healthcare providers and institutions to effectively involve caregivers during transitions from acute care hospitals to home.

Background Healthcare room environmental surfaces can be frequently and continuously contaminated with multidrug-resistant organisms (MDROs) that can persist in the environment for a prolonged time. Here, we used a dilute hydrogen peroxide (DHP) gas system for continuous room decontamination and experimentally examined the germicidal efficacy of the new technology against MDROs.Methods DHP units were installed in ceilings of a model room and the hallway in front of the room. We tested three test organisms; methicillin-resistant staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and MDR-Acinetobacter baumannii. An estimated 100–500 CFU for each test organism was inoculated and spread separately on each Formica sheet then exposed to DHP gas released into the room air. Triplicate samples were collected at times 0, 1, 3, 5, 6, 7, 24, and 48 hours. Following incubation, the colony forming units (CFU) of the test organisms on each Rodac plate were counted. Two separate experimental trials were performed for all time points. Statistical significance between intervention and control groups at each time point was determined by the Wilcoxon test, and P < 0.05 was considered significant.ResultsThere were no statistical differences in survival between DHP intervention and control groups except data at very few time points for each organism (i.e., for MRSA in Figure 1, P = 0.0063 at 24 hours; for VRE in Figure 2, P = 0.0163 at 1 hour, P = 0.0163 at 3 hours; for MDR-Acinetobacter in in Figure 3, P = 0.0369 at 24 hours). The survival curves between both groups for each organism intersected at around 24 hours. The DHP units maintained a germicidal concentration (<0.3ppm for all runs) that was inadequate, despite attempts to control factors that could interfere with the hydrogen peroxide gas concentration.Conclusion Our preliminary study using DHP demonstrated inactivity against MDROs on room surfaces, likely because we were unable to generate a sufficient germicidal level under our test conditions with the particular DHP units. Additional technologic modifications would be required to maintain stable and effective DHP level for continuous room decontamination in patient rooms.Disclosures D. Sexton, Centers for Disease Control and Prevention: Grant Investigator, Grant recipient. Centers for Disease Control and Prevention Foundation: Grant Investigator, Grant recipient. UpToDate: Collaborator, Royalty Recipient. D. J. Weber, PDI: Consultant, Consulting fee.

To determine the association (1) between shorter operative duration and surgical site infection (SSI) and (2) between surgeon median operative duration and SSI risk among first-time hip and knee arthroplasties. Retrospective cohort study A total of 43 community hospitals located in the southeastern United States. Adults who developed SSIs according to National Healthcare Safety Network criteria within 365 days of first-time knee or hip arthroplasties performed between January 1, 2008 and December 31, 2012. Log-binomial regression models estimated the association (1) between operative duration and SSI outcome and (2) between surgeon median operative duration and SSI outcome. Hip and knee arthroplasties were evaluated in separate models. Each model was adjusted for American Society of Anesthesiology score and patient age. A total of 25,531 hip arthroplasties and 42,187 knee arthroplasties were included in the study. The risk of SSI in knee arthroplasties with an operative duration shorter than the 25th percentile was 0.40 times the risk of SSI in knee arthroplasties with an operative duration between the 25th and 75th percentile (risk ratio [RR], 0.40; 95% confidence interval [CI], 0.38-0.56; P<.01). Short operative duration did not demonstrate significant association with SSI for hip arthroplasties (RR, 1.04; 95% CI, 0.79-1.37; P=.36). Knee arthroplasty surgeons with shorter median operative durations had a lower risk of SSI than surgeons with typical median operative durations (RR, 0.52; 95% CI, 0.43-0.64; P<.01). Short operative durations were not associated with a higher SSI risk for knee or hip arthroplasty procedures in our analysis.

OBJECTIVE Hospitals in the National Healthcare Safety Network began reporting laboratory-identified (LabID) Clostridium difficile infection (CDI) events in January 2013. Our study quantified the differences between the LabID and traditional surveillance methods. DESIGN Cohort study. SETTING A cohort of 29 community hospitals in the southeastern United States. METHODS A period of 6 months (January 1, 2013, to June 30, 2013) of prospectively collected data using both LabID and traditional surveillance definitions were analyzed. CDI events with mismatched surveillance categories between LabID and traditional definitions were identified and characterized further. Hospital-onset CDI (HO-CDI) rates for the entire cohort of hospitals were calculated using each method, then hospital-specific HO-CDI rates and standardized infection ratios (SIRs) were calculated. Hospital rankings based on each CDI surveillance measure were compared. RESULTS A total of 1,252 incident LabID CDI events were identified during 708,551 patient-days; 286 (23%) mismatched CDI events were detected. The overall HO-CDI rate was 6.0 vs 4.4 per 10,000 patient-days for LabID and traditional surveillance, respectively (P<.001); of 29 hospitals, 25 (86%) detected a higher CDI rate using LabID compared with the traditional method. Hospital rank in the cohort differed greatly between surveillance measures. A rank change of at least 5 places occurred in 9 of 28 hospitals (32%) between LabID and traditional CDI surveillance methods, and for SIR. CONCLUSIONS LabID surveillance resulted in a higher hospital-onset CDI incidence rate than did traditional surveillance. Hospital-specific rankings varied based on the HO-CDI surveillance measure used. A clear understanding of differences in CDI surveillance measures is important when interpreting national and local CDI data.

Describe the epidemiology of carbapenem-resistant Enterobacteriaceae (CRE) and examine the effect of lower carbapenem breakpoints on CRE detection. Retrospective cohort. Inpatient care at community hospitals. All patients with CRE-positive cultures were included. CRE isolated from 25 community hospitals were prospectively entered into a centralized database from January 2008 through December 2012. Microbiology laboratory practices were assessed using questionnaires. A total of 305 CRE isolates were detected at 16 hospitals (64%). Patients with CRE had symptomatic infection in 180 cases (59%) and asymptomatic colonization in the remainder (125 cases; 41%). Klebsiella pneumoniae (277 isolates; 91%) was the most prevalent species. The majority of cases were healthcare associated (288 cases; 94%). The rate of CRE detection increased more than fivefold from 2008 (0.26 cases per 100,000 patient-days) to 2012 (1.4 cases per 100,000 patient-days; incidence rate ratio (IRR), 5.3 [95% confidence interval (CI), 1.22-22.7]; P = .01). Only 5 hospitals (20%) had adopted the 2010 Clinical and Laboratory Standards Institute (CLSI) carbapenem breakpoints. The 5 hospitals that adopted the lower carbapenem breakpoints were more likely to detect CRE after implementation of breakpoints than before (4.1 vs 0.5 cases per 100,000 patient-days; P < .001; IRR, 8.1 [95% CI, 2.7-24.6]). Hospitals that implemented the lower carbapenem breakpoints were more likely to detect CRE than were hospitals that did not (3.3 vs 1.1 cases per 100,000 patient-days; P = .01). The rate of CRE detection increased fivefold in community hospitals in the southeastern United States from 2008 to 2012. Despite this, our estimates are likely underestimates of the true rate of CRE detection, given the low adoption of the carbapenem breakpoints recommended in the 2010 CLSI guidelines.

IntroductionThe threat of software patent suits impacts standards, dictates what software becomes part of GNU/Linux distributions, creates extra work, and makes the end-user's experience less than ideal, as will be shown in this article. In last month's issue of the TIM Review, Monica Goyal (2011) thoroughly examined some of the legislative ideas being discussed with regards