Suzanne Reed

Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices

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 12 months. 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 (RRadj) 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 ≤36 weeks). 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, non-interventional 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.

Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices.

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.

Applying Adult Learning Practices in Medical Education

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.

CELECOXIB INHIBITS STAT3 PHOSPHORYLATION AND SUPPRESSES CELL MIGRATION AND COLONY FORMING ABILITY IN RHABDOMYOSARCOMA CELLS

Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in the pediatric and adolescent population. Though treatments for localized disease have reasonable long-term success rates, if disease is diffuse at diagnosis, outcomes are far poorer. Additional and/or alternative therapies are critical for improved clinical outcomes. One potentially therapeutic target is the signal transducer and activator of transcription 3 (STAT3) pathway. STAT3 has been shown to have constitutive activation in human rhabdomyosarcoma cells; thus, inhibition of STAT3 signaling may be a mechanism to induce tumor cell death. Celecoxib has been shown, by computer modeling, to bind STAT3 at the SH2 domain and competitively inhibit native peptide binding necessary for phosphorylation and subsequent propagation of the STAT3 signaling cascade. We found that celecoxib inhibits IL-6-induced and persistent STAT3 phosphorylation and inhibits cell viability in human rhabdomyosarcoma cells. We found that genes downstream of STAT3 (BCL-2, survivin, cyclin D1) were downregulated with celecoxib. Celecoxib also inhibits colony formation and cell migration. Our results suggest that, though known more commonly as a cyclooxygenase-2 (COX-2) inhibitor, celecoxib could act through the STAT3 pathway as well. More importantly, its effect on cell migration and clonogenic colony forming ability make it a potentially useful therapeutic agent for rhabdomyosarcoma, especially in metastatic disease whose clinical outcome is marginal at best with current therapies.

Hormonal contraception use and pregnancy in adolescents with sickle cell disease: analysis of Michigan Medicaid claims.

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.

In pursuit of meaningful use of learning goals in residency: A qualitative study of pediatric residents

Purpose 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. Method 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. Results 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. Conclusions 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.

Practical Suggestions for the Creation and Use of Meaningful Learning Goals in Graduate Medical Education.

From the Department of Pediatrics, Nationwide Children’s Hospital, Ohio State University School of Medicine, Columbus, Ohio (Drs Reed and Mahan); Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colo (Drs Lockspeiser, Hanson, and Rosenberg); Department of Pediatrics, Wright State University Boonshoft School of Medicine, Dayton Children’s Hospital, Dayton, Ohio (Dr Burke); Department of Pediatrics, Children’s Hospital at Dartmouth, Geisel School of Medicine at Dartmouth, Hanover, NH (Dr Gifford); Department of Pediatrics, Riley Hospital for Children and IU School of Medicine, Indianapolis, Ind (Dr McKenna); and Department of Pediatrics, University of California Davis School of Medicine, Sacramento, Calif (Dr Li) The authors declare that they have no conflict of interest. Address correspondence to Suzanne Reed, MD, Division of Hematology/Oncology/BMT, Nationwide Children’s Hospital, 700 Children’s Dr, Columbus, OH 43205 (e-mail: suzanne.reed@nationwidechildrens.org).

Does emotional intelligence predict breaking bad news skills in pediatric interns? A pilot study

Background While both patients and physicians identify communication of bad news as an area of great challenge, the factors underlying this often complex task remain largely unknown. Emotional intelligence (EI) has been positively correlated with good general communication skills and successful leadership, but there is no literature relating EI to the delivery of bad news. Purpose Our objectives were to determine: 1) performance of first-year pediatric residents in the delivery of bad news in a standardized patient (SP) setting; and 2) the role of EI in these assessments. Our hypothesis was that pediatric trainees with higher EI would demonstrate more advanced skills in this communication task. Methods Forty first- year residents participated. Skill in bad news delivery was assessed via SP encounters using a previously published assessment tool (GRIEV_ING Death Notification Protocol). Residents completed the Emotional and Social Competency Inventory (ESCI) as a measure of EI. Results Residents scored poorly on bad news delivery skills but scored well on EI. Intraclass correlation coefficients indicated moderate to substantial inter-rater reliability among raters using the delivering bad news assessment tool. However, no correlation was found between bad news delivery performance and EI. Conclusions We concluded that first-year pediatric residents have inadequate skills in the delivery of bad news. In addition, our data suggest that higher EI alone is not sufficient to effectively deliver death news and more robust skill training is necessary for residents to gain competence and acquire mastery in this important communication domain.Background While both patients and physicians identify communication of bad news as an area of great challenge, the factors underlying this often complex task remain largely unknown. Emotional intelligence (EI) has been positively correlated with good general communication skills and successful leadership, but there is no literature relating EI to the delivery of bad news. Purpose Our objectives were to determine: 1) performance of first-year pediatric residents in the delivery of bad news in a standardized patient (SP) setting; and 2) the role of EI in these assessments. Our hypothesis was that pediatric trainees with higher EI would demonstrate more advanced skills in this communication task. Methods Forty first- year residents participated. Skill in bad news delivery was assessed via SP encounters using a previously published assessment tool (GRIEV_ING Death Notification Protocol). Residents completed the Emotional and Social Competency Inventory (ESCI) as a measure of EI. Results Residents scored poorly on bad news delivery skills but scored well on EI. Intraclass correlation coefficients indicated moderate to substantial inter-rater reliability among raters using the delivering bad news assessment tool. However, no correlation was found between bad news delivery performance and EI. Conclusions We concluded that first-year pediatric residents have inadequate skills in the delivery of bad news. In addition, our data suggest that higher EI alone is not sufficient to effectively deliver death news and more robust skill training is necessary for residents to gain competence and acquire mastery in this important communication domain.

IUD use among parous women and risk of uterine perforation: a secondary analysis

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.

Mind-Body Skills Training for Resident Wellness: A Pilot Study of a Brief Mindfulness Intervention

Background: Interventions to address burnout include mind-body skills training (MBST), but few studies have evaluated the feasibility of MBST for busy pediatric residents. Objective: In this pilot study, we tested the feasibility of a brief MBST intervention, using in-person peer-led training supported by online modules, to decrease stress and burnout in pediatric resident physicians. Methods: Of 99 (10%) residents, 10 residents at Nationwide Children’s Hospital in Ohio participated in up to four 90-minute MBST sessions more than 1 month, led by a co-resident with 5 years of informal training in mind-body skills. Participants were offered 8 assigned online modules through OSU Center for Integrative Health and Wellness. Measures including Maslach Burnout Inventory (MBI), Cohen’s Perceived Stress, Smith’s Brief Resilience, Cognitive and Affective Mindfulness Scale-Revised, and Neff’s Self-Compassion Scale (NSS) were administered before (T1) and after (T2) the course. Participants were offered optional monthly “maintenance” sessions for 6 months and completed a third set of measures at this follow-up (T3). Results: The residents completed an average of 4.3/8 online modules and attended an average of 2.8/4 in-person sessions. There was significant improvement in positive attitude, perceived stress, and resilience post intervention (T2). Follow-up evaluation (T3) also demonstrated significant improvement in burnout (depersonalization) and mindfulness. More than 75% of participants found the course worthwhile. Conclusions: A short mixed-method mindfulness-based skills course may be a practical way to offer resilience and stress management training to busy resident physicians.