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Objective To assess and compare the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) in NOMAC-E2 users with levonorgestrel-containing combined oral contraceptive (COCLNG) users. Study design This large, prospective, observational active surveillance study used a non-inferiority design. New users of NOMAC-E2 and COCLNG were recruited in 12 countries in Australia, Europe, and Latin America. Women were followed up directly and self-reported outcomes of interest were validated via treating physicians. The main outcome of interest was VTE, specifically deep venous thrombosis of the lower extremities (DVT) and pulmonary embolism (PE). Secondary outcomes included all VTE and ATE. Data on confounders were captured and independent blinded adjudication assessed the classification of events. Incidence rates, crude (HRcrude), and adjusted (HRadj) hazard ratios were calculated. Results A total of 101,498 women (49,598 NOMAC-E2 users and 51,900 COCLNG users) were enrolled and followed for up to 2 years (144,901 WY of observation). NOMAC-E2 users had a higher mean age (31.0 ± 8.63 years) than COCLNG users (29.3 ± 8.53 years) but other baseline characteristics were similar between the cohorts. The main analysis comparing the risk of DVT of the lower extremities and PE in NOMAC-E2 users versus COCLNG users yielded an HRadj of 0.59 (95% CI, 0.25-1.35) (adjusted for age, BMI, family history of VTE, and current duration of use). The risk of all VTE and ATE was not higher in NOMAC-E2 users compared with COCLNG users. Conclusion(s) NOMAC-E2 use was not associated with a higher risk of VTE or ATE compared with COCLNG.

Objective The American Board of Pediatrics Certifying Exam (ABP CE) is a high stakes exam and is important for employment and fellowship opportunities in pediatrics. Although research has suggested interventions which may improve scores, little research has focused on resident perception of preparation for the ABP CE. In this study, we aimed to better define pediatric residents' attitudes and preferences regarding preparation for the ABP CE. Methods Pediatric residents from one residency program were invited to participate in focus groups to discuss their attitudes and preferences on board exam preparation for the ABP CE. Focus groups were audio recorded and transcribed. Conventional content analysis was used to analyze qualitative data. From the transcripts, authors developed codes through an iterative process, which were then organized into categories. These categories were then grouped into themes. Results Nineteen residents participated in three focus groups. Focus group transcription analysis resulted in 49 codes, which were sorted into 26 categories. The categories were then grouped into four key themes: 1) the ABP CE is not immediately important early in residency; 2) more personalized guidance is preferred; 3) consistent board preparation focus from the residency program is valued; 4) learning format is important. Conclusions Residents believe preparation for the ABP CE increases in importance as they progress through residency, and they desire more personalized, consistent, and structured focus from their training program related to ABP CE preparation. Attention to these perceptions can help guide pediatric residency program leadership in developing effective board exam preparation strategies and curricula for their residents.

Myeloid sarcoma (MS) is an extramedullary collection of immature myeloid cells that can commonly occur with acute myeloid leukemia (AML). While head and neck presentations are not unheard of, there have been few published pediatric cases of external auditory canal MS. Here, we report a case of a 14-year-old male who presented with MS masquerading as bilateral acute otitis externa. To the best of our knowledge, this is the first reported case of a bilateral presentation leading to a new diagnosis of AML. A literature review of head and neck presentations of MS is included.

Objectives We conducted this study to characterize the frequency of insertion-, localization- and removal-related events and their clinically significant consequences among Nexplanon® (etonogestrel radiopaque contraceptive implant) users in the United States during standard clinical practice. Study design The Nexplanon Observational Risk Assessment (NORA) study was a large, prospective cohort study conducted in the United States. A total of 428 Health Care Professionals (HCPs) who had completed the Nexplanon clinical training program recruited women who were newly prescribed Nexplanon. We collected data on insertion-, localization- and removal-related events experienced during routine clinical practice via questionnaires completed by patients and HCPs. Recruitment began in December 2011 and follow-up ended in October 2017. Data analysis characterized the frequency of procedure-related events. Results We collected data on 7364 insertion procedures. The incidence of incorrect insertion (i.e., initially unrecognized non-insertion, partial insertion or deep insertion) was 12.6 per 1000 insertions (95% CI, 10.2–15.5). Pins and needles/numbness in the arm/hand/fingers was the most common patient-reported event. We obtained data on 5159 removal procedures, of which all were successful but one (due to the location of the implant in deep muscle tissue). No implants were localized outside the arm. The most common challenge reported by HCPs during implant removal was encasement of the implant within fibrotic tissue. Conclusions Events associated with the insertion, localization and removal of the Nexplanon contraceptive implant were rare and their clinical consequences were generally not suggestive of serious injury. Implications This study is the largest prospective evaluation of events associated with insertion and removal of Nexplanon during routine clinical practice. It demonstrates that complications associated with insertion and removal of Nexplanon are rare when performed by trained clinicians.

Benign adenoidal hypertrophy is the most common cause of nasopharyngeal obstruction. However, depending on size and location, masses may cause nasopharyngeal obstruction. We present our experiences with a ten-year-old female who presented with what appeared to be a large nasopharyngeal mass that was initially favored to be malignant and was ultimately found to be adenoid hypertrophy related to acute infection with adenovirus.

Objective Patients and physicians identify communication of bad news as a skill in need of improvement. Our objectives were to measure change in performance of first-year pediatric residents in the delivery of bad news after an educational intervention and to measure if changes in performance were sustained over time. Methods Communication skills of 29 residents were assessed via videotaped standardized patient (SP) encounters at 3 time points: baseline, immediately post-intervention, and 3 months post-intervention. Educational intervention used was the previously published “GRIEV_ING Death Notification Protocol.” Results The intraclass correlation coefficient demonstrated substantial inter-rater agreement with the assessment tool. Performance scores significantly improved from baseline to immediate post-intervention. Performance at 3 months post-intervention showed no change in two subscales and small improvement in one subscale. Conclusions We concluded that breaking bad news is a complex and teachable skill that can be developed in pediatric residents. Improvement was sustained over time, indicating the utility of this educational intervention. Practice implications This study brings attention to the need for improved communication training, and the feasibility of an education intervention in a large training program. Further work in development of comprehensive communication curricula is necessary in pediatric graduate medical education programs.

Objectives The objective was to measure the rate of unintended pregnancies in women using levonorgestrel-releasing intrauterine systems (LNG IUSs, releasing 20 mcg LNG daily) and copper intrauterine devices (IUDs) in a typical population of IUD users and to describe associated complications. Methods A multinational, prospective, non-interventional cohort study of new users of LNG IUS and copper IUDs was performed. Following a baseline survey, study participants and their physicians completed one follow-up questionnaire after 12 months. A multifaceted four-level follow-up procedure minimized loss to follow-up. Patient-reported outcomes were validated by the treating physicians. Results A total of 61,448 women with a newly inserted IUD were enrolled in six European countries between 2006 and 2012. The copper IUD cohort contained more than 30 different types. Validated 1-year follow-up information for 58,324 users between 18 and 50 years of age (70% using LNG IUS, 30% using copper IUDs) was collected. A total of 118 contraceptive failures occurred (26 LNG, 92 copper). Both types of IUD were highly effective, with overall Pearl indices of 0.06 [95% confidence interval (CI): 0.04–0.09] and 0.52 (95% CI: 0.42–0.64) for LNG IUS and copper IUDs, respectively. The adjusted hazard ratio for LNG IUS vs. copper IUDs was 0.16 (95% CI: 0.10–0.25). Tenty-one pregnancies (7 LNG IUS, 14 copper IUD) were ectopic, yielding an adjusted hazard ratio for ectopic pregnancy of 0.26 (95% CI: 0.10–0.66). Conclusions The contraceptive failure rate was low with both IUDs. However, the LNG IUS was associated with a significantly lower risk of pregnancy, including ectopic pregnancy, than the copper IUDs. Implications To our knowledge, this is the first large-scale, multinational, prospective epidemiological study to measure and compare the contraceptive effectiveness of LNG IUSs and copper IUDs during routine clinical practice. Clinicians and patients should be aware of differences in rates of unintended pregnancies and associated complications in relation to IUD us.

Childhood acute lymphoblastic leukemia achieves excellent cure rates in part due to induction chemotherapy including high dose corticosteroids. Hypertension (HTN) is a known complication of corticosteroids, but incidence and risk factors for steroid-induced HTN are poorly understood. We sought to describe these using a large pediatric health database. Of the 5578 unique patients receiving induction chemotherapy, 14.7% received anti-HTN medications during their initial hospital admission. We found that age below 1 year, obesity, secondary diabetes mellitus, and abnormal glucose were associated with developing steroid-induced HTN. We also found that ICD-9 codes had poor sensitivity for detecting treatment of HTN, suggesting underreporting by physicians.

The RAM immunophenotype has been recently described as a subtype of acute myelogenous leukemia (AML) that is characterized clinically by extremely poor prognosis. We present a case of AML with RAM immunophenotype in a 5-year-old patient that resulted in poor outcome despite early hematopoietic cell transplant. We describe the unusual morphologic features that, along with the distinct immunophenotype, may provide initial diagnostic clues and further justify the classification of this AML variant as a rather distinct subtype.

Objective The objective of the study was to determine if delivery and lactation are risk factors for complete intrauterine device perforations. Study design We performed a reanalysis of the European Active Surveillance Study on Intra-Uterine Devices data set using complete penetration of the myometrium as the definition for perforation. Results Of the 61,448 women enrolled (70% levonorgestrel, 30% copper devices), we identified 58 complete perforations, 30 of which occurred in lactating women. Incidence per 1000 insertions was 4.5 (95% confidence interval [CI]: 3.0–6.4) for lactating and 0.6 (95% CI: 0.4–0.9) for nonlactating women. Time since delivery was also associated with perforation risk. Conclusions Lactation and delivery are independent cofactors for perforation. Results do not differ when restricting the definition of perforation.

Background Access to effective family planning is of great importance for women with sickle cell disease (SCD) due to the increased frequency of pregnancy complications. However, little is known regarding use of hormonal contraception, complications of contraception, and pregnancy in young women with SCD. Study Design We abstracted diagnostic codes, procedure codes and pharmacy claims from women with SCD, aged 13–21 years, enrolled in Michigan Medicaid between 1/1/2000 and 12/31/2003 with ≥9 months of continuous eligibility. Results We identified 250 women with SCD with an average period of continuous Medicaid enrollment of 20 months. Claims for hormonal contraception could be identified in only 20 patients (8%, 95% CI 5–12%). The most commonly prescribed method ( n =12) was depot medroxyprogesterone (DMPA) acetate. Venous thromboembolism and osteopenia were rarely identified ( n ≤10) and occurred only in women with no recorded use of hormonal contraception. In the total population, 64 patients had one pregnancy and 16 had ≥2 pregnancies during the 4-year study period. Among adolescents (13–18 years), 49 (30%) of 195 patients (95% CI 24–37%) had 59 pregnancies. By 12 weeks postpartum, few patients ( n ≤10) with a record of delivery had hormonal contraception claims. Conclusions In a publicly insured population of young women with SCD, pregnancy was more commonly identified than hormonal contraception use. Our work suggests that significant gaps may exist in family planning care for young women with SCD.

INTRODUCTION:To characterize the frequency of insertion- and removal-related events among Nexplanon users in the US during standard clinical practice.METHODS:This large, prospective, non-interventional cohort study followed 7,369 new users of Nexplanon recruited by US health care professionals (HCPs

Residency is a high-risk period for physician burnout. We aimed to determine the short-term stability of factors associated with burnout, application of these data to previous conceptual models, and the relationship of these factors over 3 months. Physician wellness questionnaire results were analyzed at 2 time points 3 months apart. Associations among variables within and across time points were analyzed. Logistic regression was used to predict burnout and compassionate care. A total of 74% of residents completed surveys. Over 3 months, burnout ( P = .005) and empathy ( P = .04) worsened. The most significant cross-sectional relationship was between stress and emotional exhaustion (time 1 r = 0.61, time 2 r = 0.68). Resilience was predictive of increased compassionate care and decreased burnout ( P < .05). Mindfulness was predictive of decreased burnout ( P < .05). Mitigating stress and fostering mindfulness and resilience longitudinally may be key areas of focus for improved wellness in pediatric residents. Larger studies are needed to better develop targeted wellness interventions.

Medical education aims to equip physicians for lifelong learning, an objective supported by the conceptual framework of self-regulated learning (SRL). Learning goals have been used to develop SRL skills in learners across the medical education continuum. This study's purpose was to elicit residents' perspectives on learning goal use and to develop explanations suggesting how aspects of the learning environment may facilitate or hinder the meaningful use of learning goals in residency.Resident focus groups and program director interviews were conducted in 2012-2013, audio-recorded, and transcribed. Programs were selected to maximize diversity of size, geographic location, type of program, and current use of learning goals. Data were analyzed using the constant comparative method associated with grounded theory. Further analysis compared themes frequently occurring together to strengthen the understanding of relationships between the themes. Through iterative discussions, investigators built a grounded theory.Ninety-five third-year residents and 12 program directors at 12 pediatric residency programs participated. The analysis identified 21 subthemes grouped into 5 themes: program support, faculty roles, goal characteristics and purposes, resident attributes, and accountability and goal follow-through. Review of relationships between the themes revealed a pyramid of support with program support as the foundation that facilitates the layers above it, leading to goal follow-through.Program support facilitates each step of the SRL process that leads to meaningful use of learning goals in residency. A strong foundation of program support should include attention to aspects of the implicit curriculum as well as the explicit curriculum.

The application of the best practices of teaching adults to the education of adults in medical education settings is important in the process of transforming learners to become and remain effective physicians. Medical education at all levels should be designed to equip physicians with the knowledge, clinical skills, and professionalism that are required to deliver quality patient care. The ultimate outcome is the health of the patient and the health status of the society. In the translational science of medical education, improved patient outcomes linked directly to educational events are the ultimate goal and are best defined by rigorous medical education research efforts. To best develop faculty, the same principles of adult education and teaching adults apply. In a systematic review of faculty development initiatives designed to improve teaching effectiveness in medical education, the use of experiential learning, feedback, effective relationships with peers, and diverse educational methods were found to be most important in the success of these programs. In this article, we present 5 examples of applying the best practices in teaching adults and utilizing the emerging understanding of the neurobiology of learning in teaching students, trainees, and practitioners. These include (1) use of standardized patients to develop communication skills, (2) use of online quizzes to assess knowledge and aid self-directed learning, (3) use of practice sessions and video clips to enhance significant learning of teaching skills, (4) use of case-based discussions to develop professionalism concepts and skills, and (5) use of the American Academy of Pediatrics PediaLink as a model for individualized learner-directed online learning. These examples highlight how experiential leaning, providing valuable feedback, opportunities for practice, and stimulation of self-directed learning can be utilized as medical education continues its dynamic transformation in the years ahead.

Osteopetrosis (OP) is a clinically and genetically heterogeneous disorder characterized by increased bone density. Associations between OP and other clinical entities are rare but include muscular degeneration, Dandy-Walker syndrome, craniosynostosis, and poikiloderma. Infantile OP has also been diagnosed in a group of infants with neuronal storage disease. An association between OP and juvenile xanthogranuloma (JXG) has never been previously reported. Herein we present a case of an intermediate form of OP in a newborn who presented with hepatosplenomegaly and pancytopenia. Histologic evaluation of a bone marrow biopsy demonstrated abnormally thickened bony trabeculae. A liver biopsy demonstrated prominent expansion of portal areas by a histiocytic infiltrate expressing CD45, CD14, CD68, CD163, factor XIIIa, and fascin, while the biopsy was negative for S100 and CD1a. These findings were those associated with JXG. Genetic testing demonstrated a mutation involving the Pleckstrin homology domain-containing family M member 1 (PLEKHM1) gene. A different mutation in this gene has been previously reported in one other patient with OP. Our case is the 2nd reported case with PLEKHM1 mutation in a patient with a mild form of OP. It also demonstrates the 1st reported occurrence of OP concomitantly with JXG.

Objectives The objectives were to identify and compare the incidence of uterine perforation and other medically adverse events associated with levonorgestrel-releasing intrauterine systems (LNG-IUSs, releasing 20 mcg LNG daily) and copper intrauterine devices (IUDs) under routine conditions of use in a study population representative of typical users. Methods and materials This is a multinational, prospective, non-interventional cohort study with new users of LNG-IUSs and copper IUDs. In addition to a baseline questionnaire, women and their treating health care professional completed a single follow-up questionnaire after 12months. All patient-reported outcomes were validated by the treating physicians. Results A total of 61,448 women in six European countries were followed between 2006 and 2013 for more than 68,000 women-years of observation (70% LNG, 30% copper devices). Overall, 81 uterine perforations were reported: 61 for LNG-IUSs [1.4 per 1000 insertions (95% confidence interval {CI}: 1.1–1.8)] and 20 for copper IUDs [1.1 per 1000 insertions (95% CI: 0.7–1.7)], for an adjusted risk ratio (RR adj ) of 1.6 (95% CI: 1.0–2.7) when adjusted for age, body mass index, breastfeeding at time of insertion and parity. Breastfeeding at time of insertion was associated with a sixfold increase (RR 6.1, 95% CI: 3.9–9.6), with no differences between LNG and copper IUD users. Sixty-three of the total 81 perforations were associated with previously suspected risk factors (e.g., breastfeeding, time since last delivery ≤36weeks). No perforations led to serious illness or to injury of intra-abdominal or pelvic structures. Conclusions Uterine perforation incidence in this study was low, with a benign clinical course thereafter. The LNG-IUSs and copper IUDs did not have clinically important differences in perforation rates. Implications The European Active Surveillance Study on Intrauterine Devices is the first large-scale, prospective, noninterventional study to compare the perforation risk in LNG-IUS and copper IUD users. It is the first to examine the independent roles that breastfeeding status and postpartum status have on perforation risk. Conducted during routine clinical practice, the findings are generalizable to broader populations.