bluuebunny/crossref_metadata_2025 huggingface dataset:
1104. Antibiotic Prophylaxis for the Endoscopic Endonasal Approach
Authors: DeKerlegand Alaina , Vilar Jason , Persaud Rosemary
Published: October 2019

Background

Evidence available to guide perioperative antibiotic prophylaxis for endoscopic endonasal (EEN) procedures remains limited. The primary objective of this study was to characterize the impact of antibiotic prophylaxis on the incidence of post-operative central nervous system (CNS) or sinonasal infections in patients undergoing EEN procedures.

Methods

This was an IRB-approved descriptive analysis including patients >18 years of age who underwent EEN surgery at AdventHealth Orlando over a 3-year period. Patients were excluded if they had an infection present prior to surgery, ongoing antibiotic treatment (other than surgical prophylaxis) at the time of surgery, or a basic sinonasal surgery which lacked CNS penetration. The primary endpoint assessed was the rate of CNS or sinonasal infection within 30 days of EEN procedure.

Results

After screening 160 patient encounters, a total of 118 patients were included. The most common antibiotic prophylaxis utilized was ceftriaxone, followed by cefazolin, or alternative/combination therapy (72.8% vs. 13.6% vs. 13.6% of cases, respectively). There were 4 total patients who met the primary endpoint, and all 4 cases were due to a diagnosis of meningitis (overall rate 3.4%). Infection rate by antibiotic prophylaxis was 2.4% for ceftriaxone, 0% for cefazolin, and 14.3% for alternative/combination therapy. Based upon the retrospective nature of this study, we were unable to account for provider preference in selection of surgical prophylaxis or other surgeon-specific factors.

Conclusion

In this retrospective descriptive analysis, rates of CNS or sinonasal infections occurred at a rate similar to previously published literature. Larger, prospective studies are warranted to evaluate the impact of antibiotic selection on the rate of CNS or sinonasal infections post-EEN procedures.

Disclosures

All authors: No reported disclosures.
1107. Impact of Routine Education and Data Feedback on the Durability of an Antimicrobial Stewardship Intervention for Outpatient Urinary Tract Infections
Authors: Funaro Jason , Moehring Rebekah W , Liu Beiyu , Lee Hui-Jie , Sarubbi Christina , Anderson Deverick J , Wrenn Rebekah
Published: October 2019

Background

Achieving lasting, sustainable effects in outpatient AS interventions has been a challenge for many programs. Our group observed an initial benefit of an outpatient AS intervention focused on diagnosis and management of urinary tract infections (UTIs). However, prescribing habits trended back toward baseline over time. This study aimed to evaluate the impact of routine education and comparative data feedback on the durability of an outpatient AS intervention for UTIs.

Methods

We conducted a prospective quasi-experimental study at one primary care (PC) and one urgent care (UC) clinic to evaluate the durability of an outpatient AS intervention implemented in August 2017 and November 2017, respectively. Clinicians who treated adult patients with a diagnosis of acute UTI at either clinic participated in the study. The initial intervention (phase 1) included development of clinic-specific antibiograms and UTI diagnosis and treatment guidelines. Approximately 12 months after the initial intervention, routine education along with clinic- and comparative provider-specific feedback reports were emailed to clinicians at regular intervals (phase 2). The primary outcome was percent of encounters in which first- or second-line antibiotics were prescribed. Pre- and post-intervention phase and trend changes were assessed using an interrupted time-series approach.

Results

Data were collected on 792 and 3,720 UTI encounters at PC and UC, respectively. In the 12 months after the initial intervention, rates of guideline concordance were 73% at PC and 57% at UC (Figures 1 and 2). After routine data feedback was provided for approximately 7 months at PC and 5 months at UC, rates of guideline concordance remained relatively stable at 75% for PC and 61% at UC. An initial 37% relative reduction in fluoroquinolone (FQ) use was observed during phase 1 which was further reduced by an additional 18% during phase 2.

Conclusion

Routine provision of clinic-specific feedback and peer comparisons sustained rates of guideline-concordant prescribing at two outpatient clinics. This intervention required significant resources for data analysis and delivery, but it was successful in decreasing rates of FQ prescribing and maintaining clinician engagement.

Disclosures

All authors: No reported disclosures.
1112. Improving Urine Culturing Practices in a Neurocritical Care Unit through a Multidisciplinary Algorithm-Based Approach
Authors: Hazen Dana , Snyderman William , Sadowski Josh , Kelley Kristen , Beeler Cole , Webb Douglas , Dbeibo Lana , Page Shannon , Desai Armisha , Rodgers Richard , Brewer Brian , Singh Ranjeet , Bortenschlager Lawrence
Published: October 2019

Background

Asymptomatic bacteriuria is common in hospitalized patients with urinary catheters. Inappropriate urine culturing as part of reflexive response to fever contributes to unnecessary and excessive antibiotic use, selection for resistant organisms, increased risk for Clostridium difficile infections, and false elevation in catheter-associated urinary tract infection (CAUTI) rates. This project aimed to implement an evidence-based urine culture algorithm in a 33-bed neurocritical care unit, a unit with a historically elevated CAUTI rate due to a high prevalence of noninfectious fever.

Methods

A multidisciplinary quality improvement project was initiated in August 2018 by the Infection Prevention, Quality and Safety, Neurocritical Care, Trauma, and Neurosurgery teams of an urban academic health center. The group implemented a urine culture algorithm that was adapted from the Infectious Diseases Society of America (IDSA) guidelines that clearly highlighted appropriate indications for sending urine cultures. The team agreed to utilize a urinalysis with reflex to culture as the preferred method to evaluate for CAUTI. The algorithm was implemented in September 2018. Outcomes were compared for pre-implementation (March-August 2018) and post-implementation (September 2018–February 2019).

Results

The NHSN CAUTI rate decreased from 4.52/1,000 Foley days to 1.27/1,000 Foley days (P-value 0.037) as a result of the intervention. The number of urine cultures ordered decreased by 82% after implementation. No cases of bacteremia or mortality secondary to a urinary source were identified during the project. Total days of antibiotic therapy for the unit was similar between the pre- and post-implementation time periods (P = 0.631).

Conclusion

Implementation of a urine culture algorithm in a neurocritical care unit resulted in reduced CAUTI rate with less financial and operational waste in unnecessary orders and treatment, without resulting in adverse events to patients as a result of missed diagnosis.

Disclosures

All authors: No reported disclosures.
1113. Outpatient Antimicrobial Stewardship: Targets for Urinary Tract Infections
Authors: Mergenhagen Kari A , Wattengel Bethany A , DiTursi Sara , Schroeck Jennifer , Sellick John A
Published: October 2019

Background

Urinary tract infections (UTIs) remain one of the most commonly diagnosed infectious diseases in the United States in both the inpatient and outpatient settings, accounting for 10.5 million outpatient visits in 2007. Of these visits, 5.4 million were seen in primary care offices. Outpatient antimicrobial stewardship programs are emerging and a focused approach to UTIs is needed to help guide new programs.

Methods

Data were collected by retrospective chart review of outpatient males at the VA Western New York Healthcare System using encounters from January 2005 to March 2018. Appropriate treatment was defined as antimicrobial prescribing in the setting of at least 2 signs/symptoms of UTI. Categorical data were analyzed using the chi-square test and continuous data using the Student t-test. Factors that differed significantly (P < 0.05) between the comparator groups were built into a multivariate logistic regression model to determine factors associated with inappropriate prescribing, which were presented as an Odds Ratio (OR) and 95% Confidence Interval (CI).

Results

A total of 607 outpatients met criteria for inclusion, of which 40% were treated inappropriately. Of the 60% treated appropriately (therapy was indicated and empiric drug choice was correct), 95% of patients received a correct dose and 57% received an appropriate duration. Several risk factors were identified for inappropriate prescribing. Female patients were more likely to be treated inappropriately, OR 4.7 (95% CI, 2.4–9.1). Patients with a higher Charlson Comorbidity Index of 5–10 were 2.9 times more likely to be treated inappropriately (95% CI, 1.8–5.0). Those patients who received a urine culture or imaging were more likely to be treated appropriately: OR 0.6 (95% CI, 0.4–0.9) and 0.5 (95% CI, 0.3–0.7), respectively.

Conclusion

Outpatient antibiotic prescribing for UTIs is suboptimal. Outpatient stewardship programs may wish to educate providers on symptoms of UTI. Interestingly, those with signs and symptoms consistent with UTI were more likely to have a urine culture and/or imaging completed suggesting that providers were aware of a true diagnosis of a UTI. Stewardship programs should pay special attention to patients with numerous comorbidities as they are often inappropriately treated.

Disclosures

All authors: No reported disclosures.
1114. Oral β-lactams for the Treatment of Escherichia coli Bacteremia Secondary to Complicated Urinary Tract Infections Including Pyelonephritis
Authors: Harrington Nicole , Doran Megan , May Stephen , Care Julianne , Laude Jillian , Lee Stephanie
Published: October 2019

Background

Complicated urinary tract infections (cUTI) including pyelonephritis may result in bacteremia, increasing the rate of morbidity and mortality. The Infectious Diseases Society of America recommends a fluoroquinolone as empiric therapy or trimethoprim/sulfamethoxazole as definitive therapy for acute pyelonephritis (AP). Oral β-lactams (BL) are considered sub-optimal based on historical efficacy data with aminopenicillins and variable bioavailability. Increasing resistance and toxicity with preferred agents, justifies further evaluation of oral BL for E. coli bacteremia secondary to urinary source.

Methods

This was a single-center, retrospective cohort study of patients with E. coli bacteremia secondary to AP or cUTI who received oral step-down therapy with a BL or non-BL. The primary outcome was the rate of clinical success defined by microbiological cure, clinical cure, and infection-related readmission. Secondary outcomes were time to oral step-down, total days of therapy, length of hospital stay, incidence of therapy escalation, 30-day readmissions, and antibiotic-associated adverse events.

Results

A total of 46 patients were included, with 23 patients in each group. The difference in clinical success between the BL and non-BL groups was not statistically significant (91.3% vs. 100%, P = 0.489). The most frequent oral step-down agents prescribed were cephalexin and ciprofloxacin. The median time to oral step-down was significantly lower in the non-BL group (4.39 vs. 3.41 days, P = 0.038), and the median duration of therapy in each group was 15 days. No patients required therapy escalation after oral step-down or had infection-related readmission within 30 days of discharge.

Conclusion

The observed clinical success rate of 91.3% remains consistent with previous studies evaluating oral BL as step-down therapy for Enterobacteriaceae bloodstream infections. The results of this study support the safety and efficacy of oral BL as step-down therapy for E. coli bacteremia due to cUTI, although larger studies may be beneficial.

Disclosures

All authors: No reported disclosures.
1119. Implementation of Pediatric Antimicrobial Stewardship Rounds in a Children’s Hospital
Authors: Tucker Natalie , Saleh Ezzeldin , Rodriguez Marcela
Published: October 2019

Background

Antimicrobial stewardship programs (ASP) are required in all acute care hospitals per The Joint Commission. ASP must adhere to the recommendations laid out by the Centers for Disease Control and Prevention, but how each ASP chooses to implement these recommendations is left to the individual program. In January 2018, we began formal antimicrobial stewardship (AMS) walking rounds, led by infectious diseases trained physician and pharmacist, in our 99-bed pediatric hospital.

Methods

In January 2018, we started twice-weekly AMS rounds on the pediatric hospitalist service. A custom-made “Antimicrobial Stewardship Patient List” was designed in our electronic medical record (EMR) to generate a list of all patients receiving antibiotics. The ASP team (comprised of an infectious diseases pharmacist and a pediatric infectious diseases physician) reviewed EMR charts to determine antibiotic prescribing appropriateness and design recommended interventions. Any recommendations and teaching points were then discussed with the hospitalist team in person. After piloting the hospitalist service, AMS rounds were extended to include the general surgery patients and finally the intensive care unit. Data on number of charts reviewed, proposed interventions, and acceptance rates were collected throughout the process. Descriptive statistics were used to assess the intervention data.

Results

In the first year of the program, 427 patient charts were reviewed with 186 identified interventions. In total, 156 (84.3%) of the interventions were accepted and implemented by the primary team. The most common types of interventions were the duration of therapy (29%), antibiotic discontinuation (16.7%), intravenous to oral conversion (11.3%), de-escalation (10.2%), and infectious diseases consult (5.9%).

Conclusion

Pediatric AMS rounds led to the successful implementation of the majority of recommended interventions. Future goals of the program include calculating days of therapy per 1000 patient-days to assess antibiotic consumption before and after AMS rounds and to expand into other services to further promote appropriate antibiotic use in hospitalized pediatric patients.

Disclosures

All authors: No reported disclosures.
1121. Pediatric Urgent Care Providers’ Approach to Antibiotic Stewardship: A National Survey
Authors: Hamdy Rana F , Nedved Amanda , Obremskey Jill C , Fung Melody , Liu Cindy , Montalbano Amanda
Published: October 2019

Background

A high proportion of urgent care visits are for acute infectious conditions. Emerging data have shown that outpatient antibiotic prescribing for acute respiratory conditions is highest in urgent care settings; however, this has not been specifically studied among pediatric urgent cares. The objective of this study was to survey pediatric urgent care providers about their approach to antibiotic stewardship.

Methods

Members of the Society for Pediatric Urgent Care were recruited via e-mail to participate in a quality improvement antibiotic stewardship project. A pre-implementation survey developed by study investigators was piloted with several pediatric urgent care physicians and revised based on feedback. The finalized REDCap survey was sent to participants via e-mail in March 2019. Descriptive statistics were used to analyze the survey responses.

Results

A total of 156 providers completed the survey; 83% were board-certified pediatricians. Almost all (98%) indicated that antibiotic stewardship programs are important to optimize antibiotic use in urgent care. Just over half (53%) indicated that their urgent care center provides guidelines for prescribing antibiotics for acute respiratory tract infections. Treating patients with an underlying complex medical condition was the most common reason (21%) providers would deviate from guidelines. The most commonly cited barriers to appropriate prescribing for acute respiratory infections were patient expectations (93%), psychosocial barriers (40%), lack of clear evidence-based recommendations (15%), and lack of access to guidelines on prescribing (15%).

Conclusion

Most pediatric urgent care providers feel that antibiotic stewardship is important and would not impede their clinical approach. Parental expectations of receiving antibiotics were viewed as the most common barrier to appropriate prescribing. This work will be used to promote directed interventions to improve appropriateness of antibiotic prescribing for target diagnoses in pediatric urgent care centers.

Disclosures

All authors: No reported disclosures.
1124. Impact of a Best Practice Advisory for Pediatric Patients with Staphylococcus aureus Bloodstream Infection
Authors: Lloyd Elizabeth C , Martin Emily T , Dillman Nicholas , Nagel Jerod , Gandhi Tejal N , Tribble Alison
Published: October 2019

Background

Infectious diseases (ID) consultation and use of optimal antibiotic therapy have been shown to improve outcomes of patients with Staphylococcus aureus bloodstream infection (SA-BSI). We investigated the ability of an electronic medical record (EMR)-based best practice advisory (BPA) to enhance adherence to these practices for pediatric patients with SA-BSI.

Methods

An EMR-based BPA for SA-BSI (Figure 1) was implemented on 8/1/2017, recommending ID consultation and optimal therapy based on mecA gene rapid testing (vancomycin if mecA-positive; cefazolin or nafcillin if mecA-negative). We conducted a quasi-experimental pre/post study to evaluate impact of the BPA. Patients <21 years old admitted to C.S. Mott Children’s Hospital with SA-BSI during the pre- (1/2015 – 7/2017) and post-intervention (8/2017 – December 2018) periods were included. Demographic and clinical data were collected via chart review. Receipt of ID consult and optimal therapy before and after intervention were compared using interrupted time series (ITS) analysis with segmented regression. Time to optimal therapy was compared with segmented Cox regression.

Results

We included 99 SA-BSI episodes (70.7% pre-intervention and 29.3% post-intervention). Pre-intervention, 68.6% of patients received an ID consult compared with 93.1% post-intervention, but this was not significant with ITS analysis (Figure 2). The proportion of patients receiving optimal therapy did not significantly increase following the intervention, but time to optimal therapy significantly decreased (Figure 3). The median time to optimal therapy decreased from 26.1 hours to 5.5 hours. Cox regression showed both an immediate decrease in time to optimal therapy (HR 3.9, P = 0.009), followed by a continued decrease over time.

Conclusion

Following implementation of a novel EMR-based intervention, ID consultation for SA-BSI increased, although this was not statistically significant due to a pre-existing trend of increasing ID consults over time. Implementation of the BPA was associated with a significant decrease in time to optimal therapy, likely due to a combination of increasing ID consultation and antibiotic guidance provided by the BPA.

Disclosures

All authors: No reported disclosures
1129. Assessment of Nurses’ Views on Antimicrobial Stewardship at a Pediatric Hospital
Authors: Yu Diana , Bateman Anne , Nolt Dawn
Published: October 2019

Background

Regulatory agencies strongly encourage the development of hospital-based antimicrobial stewardship (AS) programs (ASP) to support appropriate antimicrobial prescribing. One component of an ASP is a multidisciplinary team. While the initial conception centered on a physician and a pharmacist, including nurses in AS has been highlighted due to the nurse’s vital role in patient care. There are little data on nurses’ knowledge, attitudes, and practices in AS. The aim of this project was to determine ideas, concerns, and gaps in knowledge of bedside nurses at a local hospital level.

Methods

This project was conducted at an academic pediatric hospital in an urban setting. A survey was designed to obtain nurses’ attitudes and views of AS and to address their frequency and confidence of various AS activities, including triage/isolation, allergy history, obtainment of appropriate diagnostic studies, interpretation of microbiology results, antibiotic de-/escalation, intravenous-to-oral switches of antibiotics, patient/family education, and identification of antimicrobial-associated adverse events. Respondents were asked to identify barriers to AS participation and to propose educational topics of interest. The survey was sent out to nurses, with 3 weekly reminders.

Results

155 of 513 respondents initiated the survey (response rate 30.2%); however, 112 participants completed the entire survey (completion rate 72.3%). Of the respondents, 67% believed that nurses should provide AS but only 32% themselves provided AS; furthermore, 26% of the respondents felt that nurses were equipped to provide AS. The most frequent AS activity reported was patient/family education while the least reported activity was the interpretation of microbiology reports. A correlation was identified between frequency and confidence of performing various AS-related tasks (R2 = 0.95). Barriers identified by respondents included antimicrobial knowledge, other timely priorities, and inclusion of nurses on bedside rounds.

Conclusion

Although few respondents felt prepared to provide antimicrobial stewardship, the majority (74%) were interested in learning more about how nurses could be involved. We are currently developing a nurse-centric educational curriculum based on the feedback from the survey.

Disclosures

All authors: No reported disclosures.
1132. Evaluation of Broad-Spectrum Antimicrobial Therapy for Acute Mastoiditis in Pediatric Patients: An Antimicrobial Stewardship Perspective
Authors: Kim Soyoon , Moffett Brady , Pali Beth , D’Souza Jill , Dutta Ankhi
Published: October 2019

Background

Acute mastoiditis (AM) continues to remain a serious complication of acute otitis media in children. There is a significant variation in antimicrobial management in children with AM. Recent studies and UptoDate recommends empiric coverage with vancomycin and antipseudomonal medication in patients with AM. The purpose of this study was to evaluate the epidemiology, management and outcome of AM in pediatric patients.

Methods

A retrospective, observational study was designed evaluating epidemiology and management of AM in hospitalized pediatric patients from July 1, 2011 to June 30, 2017. Patients between 6 months and 19 years of age admitted with a diagnosis of AM as per ICD 9/10 coded were included in the study. Information regarding demographic, clinical, laboratory, microbiological, radiological, antibiotic (Abx) usage, surgical intervention and outcome were collected from medical records.

Results

A total of 97 patients were evaluated (64% male, mean age 6.6 ± 4.3 years). Cultures (Cx) were obtained in 95 patients as in Figure 1. Of the patients who grew P.aeroginosa, 2 had intracranial extension, both of which were polymicrobial and 5 did not receive empiric antipseudomonal therapy but had no complications on follow-up. Table 1 shows the most common empiric Abx therapy. Fifty-nine patients (61.5%) had a change in Abx, the most common being a ceftriaxone or a combination of clindamycin and ceftriaxone. Except for those with complicated AM, none required definitive vancomycin therapy. Thirty-two patients (33%) had a complicated mastoiditis with epidural abscess, thrombosis, and/or intracranial extension. Eighty-six patients (86.8%) required surgical intervention. Mastoidectomy was performed in 34% while others had myringotomy and tympanostomy tube placement and/or drainage of subperiosteal abscesses without subsequent complications.

Conclusion

Group A Streptococcus, Streptococcus pneumoniae and Pseudomonas were the predominant pathogens in acute AM in children. Vancomycin and empiric antipseudomonal coverage may not be needed in patients with uncomplicated AM. Broader spectrum Abx with intracranial penetration should be reserved for those with complicated AM.

Disclosures

All authors: No reported disclosures.
1133. Evaluation of Antibiotic Allergy Documentation in Pediatric Patients
Authors: Wheatley Kristin H , Sterner Lauren , Villalobos-Fry Tibisay I
Published: October 2019

Background

Antibiotics are the most prescribed drug class in children and use often results in reports of adverse reactions. Of these adverse reactions, allergic reactions are documented with an incidence of 10% of all antibiotic prescriptions. Documentation of the details of the reaction is incomplete in as many as 66–84% of encounters leading to increased use of broad-spectrum antibiotics and associated adverse outcomes. The purpose of this study was to determine the incidence of complete antibiotic allergy documentation and how antibiotic selection was affected in pediatric patients.

Methods

A retrospective chart review of electronic medical records was conducted for pediatric patients admitted to a pediatric unit with a documented antibiotic allergy between September 1, 2015 and May 31, 2017.

Results

The study sample included 536 encounters, 424 individual patients and 689 total allergies. Of all admissions during the study period, 10.3% of encounters had at least one antibiotic allergy documented. Approximately 40% of the encounters were in patients aged 12–17 years. A specific antibiotic was identified in 510 instances (74.0%) whereas an antibiotic class was documented in the remaining 179 instances (26.0%). Amoxicillin was the most commonly reported agent (25.4%). Rash (33.5%) and hives (14.8%) were the most commonly reported reactions. No reaction documentation was found in 78 entries (11.3%). Sixty-six entries (9.6%) did not include a date of occurrence and 452 (65.6%) did not include any specific comments regarding the allergy. Following evaluation of allergy documentation, 87 entries (12.6%) were classified as complete. Empiric broad-spectrum antibiotics were prescribed in 184 encounters (82.5%) compared with narrow-spectrum antibiotic therapy in 39 encounters (17.5%) when an allergy was documented.

Conclusion

Incomplete documentation of antibiotic allergies was identified in almost 90% of encounters within the pediatric population admitted to Lehigh Valley Reilly Children’s Hospital. Due to the preferential use of broad-spectrum antibiotics in patients with documented antibiotic allergies, an initiative is underway to standardize evaluation and documentation of allergies in patients receiving care within the health network.

Disclosures

All authors: No reported disclosures.
LB5. A Long-Time Coming: Final 2-year Analysis of Efficacy, Durability, and Microbiome Changes in a Controlled Open-Label Trial of Investigational Microbiota-Based Drug RBX2660 for Recurrent Clostridioides difficile Infections
Authors: Orenstein Robert , Mische Sarah , Mische Sarah , Blount Ken , Blount Ken , Bancke Lindy , Su Xin , Walsh Dana , Harvey Adam , Gonzalez Carlos , Gerding Dale N , Gerding Dale N
Published: October 2019

Background

Recurrent Clostridioides difficile infection (rCDI) is an urgent public health threat associated with significant mortality and medical cost. Microbiota therapy is gaining acceptance as a strategy to reduce rCDI recurrence. We present the final 24-month analysis of clinical safety, efficacy, and microbiome restoration from a Phase 2 open-label trial of RBX2660 for prevention of CDI recurrence.

Methods

Participants with multi-recurrent CDI received <2 doses of RBX2660 delivered via enema 7 days apart in this multicenter, open-label Phase 2 study. Efficacy was defined as the absence of CDI recurrence through 56 days after the last dose and was compared with 8-week recurrence-free rates for a historical control cohort that received standard-of-care antibiotic therapy. Fisher exact test compared the proportion of treatment participants who were CDI-free by age and sex. Durability was defined as continued absence of CDI episodes beyond 8 weeks. Safety and durability assessments occurred at 3, 6, 12, and 24 months. Participant stool samples were collected prior to and for up to 720 days after treatment, and microbiome changes were assessed by shallow shotgun sequencing.

Results

The efficacy of RBX2660 to prevent rCDI at 8 weeks (78.9%; 112/142) was higher than the CDI-free rate in the historical control group (30.7%, 23/75; P < 0.0001). Age and sex did not impact efficacy. Among participants who achieved treatment success at 8 weeks and were evaluable for long-term durability (n = 95), 8 experienced a new CDI episode by the 24-month follow-up for an overall durability of 91.6%. The safety profile was consistent with previous reports for RBX2660. In total, 503 stool samples from 110 treatment responders were analyzed. Within 7 days of treatment, the relative abundance of Bacteroidia and Clostridia remained shifted higher than pre-treatment levels while Gammaproteobacteria and Bacilli declined sharply after treatment, and these changes persisted to at least 24 months.

Conclusion

RBX2660, a microbiota-based drug, was safe and efficacious for preventing rCDI with clinical durability to 24 months after treatment, independent of age or sex, and RBX2660 durability associated with durable microbiome shifts from pre-treatment to a healthier composition.

Disclosures

Robert Orenstein, DO, Rebiotix Inc. (Advisor or Review Panel member), Sarah Mische, PhD, Rebiotix Inc. (Employee), Ken Blount, PhD, Rebiotix Inc. (Employee), Lindy Bancke, PharmD, Rebiotix Inc. (Employee), Xin Su, MD, MSci, Rebiotix Inc. (Employee), Dana Walsh, PhD, Rebiotix Inc. (Employee), Adam Harvey, PhD, Rebiotix Inc. (Employee), Carlos Gonzalez, MS, Rebiotix Inc. (Consultant), Dale N. Gerding, MD, Rebiotix Inc. (Board Member).
The Effectiveness of Platelet-Rich Plasma and Radial Extracorporeal Shock Wave Compared with Platelet-Rich Plasma in the Treatment of Moderate Carpal Tunnel Syndrome
Authors: Chang Chih-Ya , Chen Liang-Cheng , Chou Yu-Ching , Li Tsung-Ying , Ho Tsung-Yen , Wu Yung-Tsan
Published: October 2019

Objectives

To evaluate the combination effect of platelet-rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) for moderate carpal tunnel syndrome (CTS), compared with PRP alone.

Design

A randomized, double-blinded, placebo-controlled trial.

Setting

A single medical center in Taiwan.

Patients

Patients diagnosed with moderate CTS.

Interventions

All subjects were administered one dose of ultrasound-guided PRP injection at baseline. After two weeks, one session of rESWT was completed in the intervention group, whereas the control group received one session of sham rESWT. Evaluations were performed at baseline and one, three, and six months post–PRP injection.

Outcome Measures

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) was measured as the primary outcome. Electrophysiological study and cross-sectional area (CSA) of the median nerve were used as secondary outcomes.

Results

All 40 enrolled subjects (male/female: 4/36) completed the study, resulting in an analysis of 32 wrists per group (total: N = 64 wrists). Compared with the control group, the intervention group did not show statistically significantly superior outcomes, except in BCTQs at one month (mean change ± SE = –11.47 ± 1.18 vs –7.06 ± 1.26, P = 0.013) and distal motor latency at three months (mean change ± SE = –0.59 ± 0.09 vs –0.30 ± 0.09, P = 0.031).

Conclusions

Combined PRP and one-session rESWT was not superior to PRP alone in treating moderate CTS. Further studies with multiple sessions of ESWT and longer follow-up periods are needed to verify the clinical efficacy of ESWT.
Omega Flex Ltd v British Standards Institution
Authors:   Intellectual Property Office
Published: October 2019

H1 Trade marks – Invalidation proceedings – Certification marks - Indications of quality - British Standards kitemark – Application for registration as a ordinary trade mark - Capacity to distinguish - Whether devoid of distinctive character – Relevance of pre-application use - Perception of the relevant public as at date of filing - Whether serving as a badge of origin – Whether descriptive of characteristics of goods or services - Whether distinctiveness acquired through use - Public policy – Deceptive marks - Bad faith –– Lack of intention to use as indicator of origin across full width of specification – Partial invalidity - Reference to CJEU ongoing in other proceedings
Democratizing Foreign Policy: Parliamentary Oversight of Treaty Ratification in Pakistan
Authors: Ghouri Ahmad
Published: October 2019

Treaties are agreements between States negotiated by government executives. They are primarily meant to govern the relationship between States, but may have implications for the economic, political, and fundamental rights of citizens. As treaties create binding legal obligations for States enforceable under international law, this article primarily argues that Parliamentary oversight of treaties is necessary for their democratic legitimacy. It analyses the Ratification of Foreign Agreements by Parliament Bill (the ‘Bill’) which is currently being debated in the Senate of Pakistan. Offering critical overview of the existing treaty making procedures in Pakistan, the article evaluates several aspects of the Bill including its definition of foreign agreements and the proposed treaty ratification procedures in comparison with international law of treaties and relevant laws of the UK, Australia, and Kenya. Based on the comparative examination of the Bill, the article makes proposals for changes in the Bill's substantive provisions and make further suggestions for improvement, such as guiding principles on treaty negotiations and procedure for treaty withdrawals. The article concludes by giving a comprehensive package of practical recommendations for further development of the Bill's provisions on treaty ratification in accordance with international best practices.
Increasing Access to Emergency Contraception, Non-Emergent Contraception, and LARC Referrals in the Emergency Room: A Resident-Based Educational Intervention
Authors: Alvarez-Galiana Veronica , Ahlschlager Lauren , Lathrop Eva , Haddad Lisa
Published: October 2019

PURPOSE:

The aim of this study is to determine whether an educational intervention improves emergency medicine residents' knowledge of and personal comfort with prescribing EC, offering non-emergent contraception, and referring patients for LARCs.

BACKGROUND:

Approximately 50% of pregnancies in the United States are unintended. Increasing access to emergency contraception (EC), non-emergent contraception, and long-acting reversible contraception methods (LARCs) is one way of decreasing unintended pregnancies. Emergency rooms enable physicians to assess a woman's risk of unintended pregnancy and afford an opportunity to intervene, if appropriate. Previous studies have found that emergency medicine physicians do not always offer EC, even in cases of sexual assault. Barriers to prescribing EC have been identified and include time constraints, lack of clinical resources, concern about discouraging regular birth control, and concern about birth defects.

METHODS:

Emergency medicine residents were given an interactive lecture on contraception with emphasis on EC. They were also given a pocketbook on contraception to keep. Pre- and post-lecture surveys were given in person, along with another 6 months later. The surveys assessed knowledge, comfort level, and prescribing/referring practices with both quantitative data and qualitative data. Data will also be extracted from the electronic medical record to assess if there was an increase in prescriptions for contraception and/or referrals to family planning.

RESULTS:

The preliminary data analysis is currently being conducted. Twenty-three emergency medicine residents completed the pre- and post-test surveys. Additional information from prescriptions and referrals will provide objective data to assess whether the educational intervention changed behavior.

DISCUSSION:

There are two hypotheses for this study. First, it is hypothesized that an educational intervention will increase emergency medicine residents' knowledge of and comfort with EC, non-emergent contraception, and LARCs. Second, there will be a significant increase in prescriptions for EC, non-emergent contraception, and referrals for LARCs one year after the educational intervention takes place. If the hypotheses are correct, residency programs and hospitals should consider developing educational strategies and policies to improve access to contraception in the emergency room and prevent unintended pregnancy.
A Novel Cervical Cerclage Model for Resident Training
Authors: Delgado Arlin , Cleberg Rachael , Gimovsky Alexis
Published: October 2019

PURPOSE:

This study aimed to assess a novel cervical cerclage model for resident training.

BACKGROUND:

Vaginal suturing can be challenging to teach and to learn due to limited operative field visualization by the surgical assistant, but is a required skill for cervical cerclage placement. There is limited data on resident training and comfort with cerclage placement using models.1,2

METHODS:

Residents in Obstetrics and Gynecology (OBGYN) at George Washington University were recruited to participate in a pre and post-test survey during a cerclage simulation training with a novel model. A cervical cerclage model was assembled using a 1 L water bottle, sutures and a “hair bun” maker. Continuous variables were compared using 2 tailed paired t tests.

RESULTS:

A total of 20 residents participated with a median of 2 ± 1.6 years of OBGYN residency. 95% of residents reported no prior cerclage simulation training; however, 60% reported previously placing cerclages in practice. Pre and post-test analysis showed a decrease in the perception of need for further training (4.05 ± 1.07 vs. 3.45 ± 0.86; p = 0.024) and resident reported more comfort performing the procedure with decreasing supervision (2.05 ± 1.02 vs. 2.3 ± 1.01; p = 0.021). 90% reported learning to place a cerclage was easy after the simulation, versus 45% beforehand.

DISCUSSION:

A novel cervical cerclage model in a training session significantly increased resident knowledge of and comfort regarding cerclage placement. Future research should replicate this study, focusing on learner achievement of clinical competency and evaluate clinical outcomes.
A Self-Evaluation of the AAMC Core EPAs During Residency
Authors: Nelson David , Gabbur Nagaraj
Published: October 2019

PURPOSE:

To have residents at all PGY levels self-evaluate their competence with regard to the Core Entrustable Professional Activities for Entering Residency (CEPAER).

BACKGROUND:

The AAMC has described thirteen areas in which all graduating medical students should be proficient and that these areas should be evaluated for potential deficiencies early in residency. However, these areas of weakness may extend well into residency as these skills may not specifically be taught during residency.

METHODS:

All residents in an Ob/Gyn program (42 in total) were asked to self-evaluate in each of the thirteen EPAs at the beginning of the academic year using Miller's Pyramid. Each resident marked his or her competency as either, “knows,” “knows how,” “shows how,” or “does.” The responses were dichotomized, grouping the “knows,” and “knows how” as “non-entrustable” and “shows how” and “does” as “entrustable.”

RESULTS:

Seven of twelve PGY1s and eight of twenty-nine PGY2-4s completed the survey. Four (57.1%) PGY1s self-evaluated as “non-entrustable” for patient handovers, obtaining informed consent, and identifying and correcting systems failures, and five (71.4%) felt “non-entrustable” in writing orders and prescriptions and in general procedures of physicians. All of the PGY2-4s felt “entrustable” in all areas except for two who felt “non-entrustable” in identifying and correcting systems failures.

DISCUSSION:

The areas noted above may warrant more concerted educational focus at the beginning of an intern's year, but identifying and correcting systems failures appears to be an area that deserves continued education during residency.
A Triple Aim Curriculum That Addresses Health Care Inequity: A Resident Driven Patient Centered QI Project that Improves Postpartum Care Utilization for a High Risk Population
Authors: Parson Jessica , Menezes Katherine , Mann Stephanie
Published: October 2019

PURPOSE:

To describe the design and implementation of a resident driven QI initiative which addresses the low percentage of patients returning for a 6-week postpartum visit in a resident obstetrics clinic.

BACKGROUND:

The postpartum period or the “fourth trimester of pregnancy” is a critical period for women’s health and well-being. At our resident clinic (2014-2016), only 21% of patients presented to their 6-week postpartum visits compared to 80-93% in other practices. As part of a new, mentored experiential approach to QI education, our residents completed a QI project based on an identified clinically relevant patient care issue.

METHODS:

12 Ob/Gyn residents (single institution) completed the IHI QI Online modules as part of a GME supported Health Systems Science initiative focused on operationalizing a Triple Aim targeted curriculum. Applying the Model for Improvement, the residents designed and implemented a QI project with the aim of 100% of postpartum patients discharged from the resident service during a 6-month period to receive a 2-week post-discharge check-in call. The % of discharged patients attending their 6-week postpartum visit was calculated and compared to the % attendance 2014-16. Data analysis: independent t test, P<0.05

RESULTS:

6 months after implementation, 97% (37/38) of patients received a 2-week check-in call. Of those contacted, there was a 45% increase in patients who returned for a 6-week postpartum visit (p<0.01).

DISCUSSION:

An educational intervention can directly improve patient care. An experiential approach to QI can facilitate knowledge application and result in improved postpartum care utilization for high risk patients.
Burnt Out and Yet Engaged: Are We Asking the Right Questions in Faculty Wellness Research?
Authors: Simpkin Arabella , Hata Susan , James Kaitlyn , Berkowitz Lori
Published: October 2019

PURPOSE:

To examines rates of work engagement and work empowerment in ob-gyn faculty, together with their perceptions on connection at work, in correlation with burnout.

BACKGROUND:

Burnout appears to be an accelerating phenomenon, threatening the health and well-being of providers and patients. There is concern, however, that the term is becoming overused and that the measures may not capture the full picture, with an assumption that the end-goal is the absence of burnout rather than the promotion of wellness.

METHODS:

Cross-sectional study of 25 ob-gyn faculty at a large academic medical center in the United States. Outcome measures: Utrecht Work Engagement Scale, Work Empowerment Scale, 2-item Maslach Burnout Inventory, and perceptions of connection in the department.

RESULTS:

Fifty-six percent of faculty met criteria for emotional exhaustion, 19% for depersonalization, and 19% for high burnout. There was no difference in years of practice and the presence of burnout (P=.74), and no association between burnout and work engagement or work empowerment (P=.33 and P=.25, respectively). Ninety-two percent feel a sense of connection and community at work and 92% trust their colleagues and feel safe discussing concerns with them.

DISCUSSION:

Emotional exhaustion, sometimes capitulated to be a sign of pathological burnout, may be an appropriate and normal response to daily activities which does not impact engagement at work. Shifting the focus away from burnout to positive psychology measures and building community may be the key to nourishing joy in practice and transforming the workplace to one that promotes wellness in the face of adversity and challenge.
Can I Get a Suggestion? Improv Training to Teach Empathy in Ob/Gyn Residents
Authors: Cai Fei , Ruhotina Merima , Bowler Melissa , Howard Elisabeth , Frishman Gary , Wohlrab Kyle
Published: October 2019

PURPOSE:

To examine improvisation training on Ob/Gyn resident empathy

BACKGROUND:

Physician empathy is associated with improved patient outcomes. Empathy training is effective in physicians, and many models exist. However, no studies have examined whether the improvements are sustained over time. Our primary aim is to determine whether an improv workshop is an effective tool to deliver empathy training. Our secondary aim is to determine whether that effect is sustained over time.

METHODS:

This is a prospective study of Ob/Gyn residents. Validated empathy surveys were administered 1 week prior to empathy training, immediately after training and 1 month later. Improv games were used in conjunction with empathy training during the intervention. Paired t-tests and McNemar’s were used to compare statistical differences at each post-intervention assessment compared to pre-intervention.

RESULTS:

22 residents participated. Empathy scores increased immediately after training (mean=113 vs 120, p=0.03), but were not sustained 1 month later (mean=113 vs 117, p=0.11). Residents reported that the workshop positively impacted their delivery of care both immediately (mean=3.5 vs 4.6, p<0.001) and 1 month later (mean=3.5 vs 4.1, p=0.04).

DISCUSSION:

Using improv comedy to delivery empathy training is associated with improved empathy scores in Ob/Gyn residents, but this improvement gravitates back to baseline over time. Residents report that the improv workshop was effective at improving empathy, even up to one month later.
Development of a Novel Method for OBGYN Resident Recruitment
Authors: Blake Rachel , Modest Anna , DiNapoli Martina , Ricciotti Hope , Mendiola Monica
Published: October 2019

PURPOSE:

We aimed to improve our resident recruitment method to promote individualized, holistic admissions and decrease applicant stress.

BACKGROUND:

The AAMC is promoting processes that utilize holistic, individualized resident applicant criteria and methods that reduce candidate stress.

METHODS:

Resident applicants were divided among six experienced faculty who selected candidates based on objective scoring of academic records. Selected applicants were emailed to rank interview date preferences within 72-hours, and then received an email with interview placement. Following interviews, applicants were surveyed about the process.

Three ranks lists were generated and compared: a behavioral-based composite rank list (BBC); a BBC with pre-interview scores included; and a traditional list. In the BBC method, faculty were blinded to pre-interview scores, and applicants were evaluated on professionalism, leadership, trainability, and fit. The traditional rank list was generated via open discussion with interviewers. The three rank lists were compared to determine concordance between methods.

RESULTS:

There were 78 applicants interviewed. There was 62.8% concordance between the BBC and traditional rank list, which dropped to 32.1% concordance when pre-interview scores were combined with BBC scores. Applicant post-invitation survey response rate was 67%; with 93.3% reporting the interview invitation process was more equitable, less stressful (82.7%), and better than other institutions (86.6%). All faculty involved in the candidate prescreen preferred the new standardized method.

DISCUSSION:

There was concordance between the BBC and standard rank lists, but not when pre-interview scores was combined with the BBC. Candidates were satisfied with the new method of invitation and faculty found the standardized pre-interview scoring method preferable.