bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

Abstract

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

Abstract

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

Abstract
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

Abstract
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.
Electronic Health Record Use During the Obstetrics and Gynecology Clerkship by Medical Student Graduates Between 2012 and 2016
Authors: Hammoud Maya , Foster Lauren , Cuddy Monica , Swanson David , Wallach Paul 
Published: October 2019

PURPOSE:
To examine medical student accounts of their EHR use during their obstetrics/gynecology (OBGYN) clerkship.

BACKGROUND:
The ability to interface with and enter into an electronic health record (EHR) is viewed as a core competency for medicine and an important skill for entry into residency for graduates of medical school.

METHODS:
An online survey about EHR use was administered to medical students after they completed USMLE Step 2 CK. For inpatient and outpatient rotations, students were asked if they used a record and if they entered notes or orders into it. Descriptive statistics for a sample of 16,366 medical students who graduated from 2012 and 2016 summarized student EHR interactions by rotation type, graduation year, and gender. ANOVA techniques were used to examine mean differences in use and entry.

RESULTS:
In 2016, the majority of students (94%) used EHRs during their OBGYN clerkship, but 26% reported “read-only” access. On the inpatient service, fewer than 10% of students reported any order entry, 58% reported entering progress notes, and 47% reported entering an admitting history and physical. Men entered into EHRs more often than women (70% vs. 67%, p<0.05). Patterns were similar within each graduation year.

DISCUSSION:
Medical school graduates entering OBGYN residencies are expected to be competent in documenting clinical encounters and entering orders, including those notes unique to OBGYN. This study shows that students may receive inadequate experience with entering information into EHRs which could translate into a lack of GME preparedness and entry-level competency.