A Refined Teach-back Observation Tool: Validity Evidence in a Pediatric Setting.

BACKGROUND: Teach Back (TB) is recommended to assess and ensure patient understanding, thereby promoting safety, quality, and equity. There are many TB trainings, typically lacking assessment tools with validity evidence. We used a pediatric resident competency-based communication curriculum to develop initial validity evidence and refinement recommendations for a Teach-back Observation Tool (T-BOT). OBJECTIVE: This study aimed to develop initial validity evidence for a refined T-BOT and provide guidance for further enhancements to improve essential TB skills training among pediatric residents. METHODS: After an interactive health literacy (HL) training, residents participated in recorded standardized patient (SP) encounters. Raters developed T-BOT scoring criteria, then scored a gold standard TB video and resident SP encounters. For agreement, Fleiss' Kappa was computed for >2 raters, and Cohen's Kappa for two raters. Percent agreement and intraclass correlation (ICC) were calculated. Statistics were calculated for gold standard (GS) and TB items overall for all six raters, and for five faculty raters. Agreement was based on Kappa: no agreement (≤0), none to slight (0.01-0.20), fair (0.21-0.40), moderate (0.41-0.60), substantial (0.61-0.80), almost perfect (0.81-1.00). KEY RESULTS: For six raters, Kappa for the GS was 0.554 (moderate agreement) with 71.4% agreement; ICC = .597; for SP encounters, it was 0.637 (substantial) with 65.4% agreement; ICC = .647. Individual item agreement for SP encounters average was 0.605 (moderate), ranging from 0.142 (slight) to 1 (perfect). For five faculty raters, Kappa for the GS was 0.779 (substantial) with 85.7% agreement; ICC = .824; for resident SP encounters, it was 0.751 (substantial), with 76.9% agreement; ICC = .759. Individual item agreement on SP encounters average was 0.718 (substantial), ranging from 0.156 (slight) to 1 (perfect). CONCLUSION: We provide initial validity evidence for a modified T-BOT and recommendations for improvement. With further refinements to increase validity evidence, accompanied by shared understanding of TB and rating criteria, the T-BOT may be useful in strengthening approaches to teaching and improving essential TB skills among health care team members, thereby increasing organizational HL and improving outcomes. [HLRP: Health Literacy Research and Practice. 2023;7(4):e187-e196.].

PLAIN LANGUAGE SUMMARY: We provide initial validity evidence for a refined T-BOT and recommendations for further enhancements to improve essential TB skills among pediatric residents. With attention to a shared understanding of TB and rating criteria, this tool may be used to improve HL training, thereby increasing organizational HL and improving outcomes.

Off to boarding school: Exploring how physicians learn in Tumor Board.

BACKGROUND: Tumor Board (TB) is a multidisciplinary care conference tradition in adult and pediatric oncology. The Commission on Cancer requires cancer programs to hold multidisciplinary cancer case conferences. Data support improvements in clinical decision-making due to TB and perception of learning value. Data are lacking on how physician participants learn in this environment. METHODS: Our exploratory, qualitative research study rooted in naturalistic inquiry explored how physician participants learn in TB. Fifteen participants were purposefully sampled and completed semi-structured interviews. Interviews were recorded, transcribed, and analyzed to produce themes. RESULTS: Five themes arose: (i) mutual educational goals by participating stakeholders are beneficial to educational experiences in TB; (ii) for trainees, presenting TB cases is important for learning; (iii) for attendees of TB, discussion and collaboration surrounding the content of presentations has implications for learning; (iv) participants of TB are responsible for cultivating their learning environment and teaching one another; and (v) virtual TB alters the opportunity to participate and engage with the subject matter, impacting learning for participants. CONCLUSIONS: Exploring TB through the lens of an educational framework is a novel approach. By identifying the facilitators and inhibitors of learning in TB, opportunities to enhance the educational process in TB are now exposed. Our study illustrates that learning in TB occurs through the cognitive apprenticeship model, and provides insight on how to best cultivate this model to improve learning. These data demonstrate the social nature of learning, and how they align with the pediatric hematology/oncology community of practice.

The Value of the Pediatric Urgent Care in Pediatric Resident Education.

OBJECTIVE: Pediatric urgent care (UC) is a growing field and may provide unique learning opportunities for pediatric residents. We aimed to assess whether a UC rotation could be feasible and meaningful and help fill educational gaps. METHODS: Within our current X + Y rotational model, we used Kern's 6-step approach for curriculum development to create a longitudinal UC educational experience for postgraduate year 2 (PGY2) pediatric residents. We assessed progress toward achieving our aim by using a mixed-methods approach matched to Kirkpatrick's levels of learning, including program annual evaluations, self-assessed UC competencies, and 360 milestone evaluations. RESULTS: A total of 14 PGY2s participated in our yearlong longitudinal rotation without duty hour violations or deviations from well child care. Thematic analysis revealed concepts of autonomy, procedural access, and intentionality of education. Residents showed statistical improvement in 4/10 milestones and 26/27 self-assessed performance items. Of 14 residents, 6 scored ≥4 on all milestones by the end of the year. CONCLUSIONS: Our curriculum demonstrates a valuable role for the pediatric UC in the procedural and clinical education of pediatric residents. Practical implications and assessment tools of such a curriculum may be valuable for others interested in integrating this learning experience into their current educational model.

Well-being factors associated with confidence in providing calm, compassionate care in pediatric residents.

OBJECTIVE: Engagement in calm, compassionate care (CCC) is important in fostering patient-centered care. We aimed to study factors which predict confidence in providing CCC in pediatric residents. METHODS: We performed a retrospective, multi-center, cohort study utilizing data from the Pediatric Resident Burnout and Resilience Study (PRB-RSC) from 2016 to 2018. The Calm Compassionate Care Scale (CCCS) was used to assess confidence in delivering CCC. We examined cross-sectional associations between CCC, demographic measures, programmatic features, and psychological scales. RESULTS: The following showed significant positive associations with confidence in providing CCC: Cognitive and Affective Mindfulness Scale, Neff's Self Compassion, Patient Reported Outcomes Measures-mental health, and Interpersonal Reactivity Index-empathetic concern. For the Maslach Burnout Index subscales, decreased personal accomplishment, increased emotional exhaustion, and increased depersonalization showed significant negative associations. CONCLUSIONS: We found that several well-being measures and an increased sense of personal accomplishment are associated with increased confidence in providing CCC. These findings underscore the interrelatedness of these measures and highlight the importance of personal accomplishment as a positive factor in trainee development. PRACTICE IMPLICATIONS: Program level interventions that decrease trainee burnout and enhance resiliency as well as support trainees' development of empathy and compassion may help trainees develop skills that promote patient-centered, compassionate care.

A Qualitative Analysis of Assessment and Evaluation Practices Within the Individualized Curriculum.

OBJECTIVE: The Accreditation Council of Graduate Medical Education requires an "individualized curriculum" (IC) in pediatric residency. A shared understanding across programs of methods to evaluate the IC is lacking. We explored pediatric program leaders' perceptions of assessment and evaluation within the IC to further understand and inform most useful practices. METHODS: We conducted a phenomenology study using semi-structured interviews to 1) determine what IC assessment and evaluation strategies are utilized in pediatric residency programs, and 2) explore program leaders' perceptions of the feasibility and value of assessment and evaluation in the IC. We recruited a purposive sample of leaders from 15 pediatric residency programs of various sizes and regions. Interviews were recorded and transcribed. Data were analyzed to produce themes. RESULTS: Three themes arose from our analysis: 1) Systematic assessment of the IC, though desired, is not robust in pediatric residency training; 2) Program differences present unique barriers and facilitators that impact the feasibility of assessment within the IC; and 3) Meaningfulness of assessment in the IC varies by stakeholder. Themes reflected perspectives on individual learner assessment and program evaluation. CONCLUSIONS: While systematic assessment and evaluation of the IC in pediatric residency training is lacking, program leaders desire feasible strategies that are meaningful to the resident, the program, and its leadership team. Leveraging current assessment and evaluation tools and aligning new assessment strategies could promote the integration of IC assessment with other assessments, minimizing burden. More structured IC assessment and evaluation could inform how to best achieve curricular goals of the IC.

A narrative medicine intervention in pediatric residents led to sustained improvements in resident well-being.

BACKGROUND: Burnout in pediatric residents is widespread. Certain factors are associated with decreased burnout, such as empathy, self-compassion, mindfulness, and resilience, while perceived stress is associated with increased burnout. Narrative medicine may reduce burnout by its impact on protective and exacerbating factors and can be an active tool to promote wellness. The objective of this pilot study was to evaluate immediate and delayed benefits of a longitudinal narrative medicine intervention for pediatric residents using qualitative and quantitative measures. MATERIALS AND METHODS: We designed a voluntary longitudinal narrative medicine intervention implemented via Zoom teleconferencing software over five months for pediatric residents at Nationwide Children's Hospital. It consisted of six one-hour long sessions where residents engaged with literature, responded to a writing prompt, and shared their reflections. It was evaluated using open-ended survey questions and established quantitative assessment tools of well-being with validity evidence. Results were compared before the intervention, immediately after, and six months later using one-way ANOVA and multiple linear regression. Qualitative data was analyzed using thematic analysis. RESULTS: Twenty-two (14% of eligible) residents participated in at least one session. After the intervention, the following themes emerged for benefits to resident well-being: the ability to Build Community, have an Outlet for Self-Expression, reap Emotional and Mental Health Benefits, and work on Personal Growth. Benefits were sustained even six months later, which has not been shown previously. While there were significant qualitative findings, between all three time points, there was no change in any quantitative well-being measures. CONCLUSION: Our longitudinal narrative medicine pilot study showed meaningful sustained qualitative benefits, though no quantitative changes, in measured well-being outcomes that have been previously associated with lower resident burnout. While not a panacea, narrative medicine can be a useful strategy for residency programs to improve pediatric resident well-being even after completion of planned interventions.Key MessageWe used a mixed-methods approach to assess the effects of a longitudinal narrative medicine intervention on well-being in pediatric residents.Open-ended responses indicated that residents found utility in and appreciated the intervention and experienced sustained improvements in their mental and emotional health, though the sample size was likely too small to show quantitative changes in well-being measures.Narrative medicine is not a panacea, but it can be a useful tool to provide to pediatric residents to promote sustained improvements in their well-being through the framework of relationship-centered care.

Are Final Residency Milestones Correlated With Early Fellowship Performance in Pediatrics?

PURPOSE: Milestones have been used to assess trainees across graduate medical education programs and reflect a developmental continuum from novice to expert. This study examined whether residency milestones are correlated with initial fellowship milestone performance in pediatrics. METHOD: This retrospective cohort study used descriptive statistics to assess milestone scores from pediatric fellows who began fellowship training between July 2017 and July 2020. Milestone scores were obtained at the end of residency (R), middle of the first fellowship year (F1), and end of the first fellowship year (F2). RESULTS: Data represent 3,592 unique trainees. High composite R scores, much lower F1 scores, and slightly higher F2 scores were found over time for all pediatric subspecialities. R scores were positively correlated with F1 scores (Spearman ρ = 0.12, P < .001) and F2 scores (Spearman ρ = 0.15, P < .001). Although scores are negligibly different when trainees graduate from residency, there were differences in F1 and F2 scores among fellows in different specialties. Those who trained at the same institution for residency and fellowship had higher composite milestone F1 and F2 scores compared with those who trained at different institutions ( P < .001). The strongest associations were between R and F2 scores for the professionalism and communication milestones, although associations were still relatively weak overall (r s = 0.13-0.20). CONCLUSIONS: This study found high R scores and low F1 and F2 scores across all shared milestones, with weak association of scores within competencies, indicating that milestones are context dependent. Although professionalism and communication milestones had a higher correlation compared with the other competencies, the association was still weak. Residency milestones may be useful for individualized education in early fellowship, but fellowship programs should be cautious about overreliance on R scores due to the weak correlation with F1 and F2 scores.

Pregnancy and pregnancy outcomes in a prospective cohort study: Final results from the Nexplanon Observational Risk Assessment Study (NORA).

OBJECTIVES: To monitor pregnancy occurrence and outcomes among Nexplanon 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 (US). Study participants with a newly inserted Nexplanon implant were recruited by health care professionals (HCPs) who had completed the Nexplanon clinical training. Via a survey, study participants were followed up at 6-month intervals for 36 months and 6 months after implant removal. Reported unintended pregnancies were validated and classified as noninsertion, preinsertion, during-use, or postremoval. RESULTS: Four hundred and twenty-eight HCPs in 47 states recruited 7364 Nexplanon users. Pregnancies included one noninsertion, eight preinsertion, three during-use, and 14 postremoval pregnancies; of these 26 pregnancies, 22 resulted in the birth of a healthy child, two resulted in an induced abortion, one resulted in a spontaneous abortion, and one resulted in an ectopic pregnancy. Six pregnancies occurred during-use (n = 3) or within 7 days following implant removal (n = 3), yielding a Pearl Index of 0.04 (95% CI, 0.02-0.09). CONCLUSIONS: Nexplanon is an effective contraceptive in real-world users; the Pearl Index was 0.02 (95% CI, 0.00-0.06) for during-use pregnancies, and 0.04 when including pregnancies that occurred within 7 days following implant removal. IMPLICATIONS: This large real-world-use study indicates that Nexplanon is as effective as shown in the preapproval clinical trials.

Accreditation Council for Graduate Medical Education Milestone Scores in Pediatrics: Pilot Study Exploring the Relationship Between Residency and Early Fellowship Scores.

BACKGROUND: The Accreditation Council for Graduate Medical Education requires Milestone-based assessments of residents and fellows. In pediatrics, 11 subcompetencies are common to both residency and subspecialty fellowship training. It is unknown whether Milestone scores achieved during residency are related to Milestone scores achieved in early fellowship. OBJECTIVE: To assess the relationship between final residency Milestones scores and first-year fellowship Milestones scores in the 11 common subcompetencies (CSCs) across pediatric subspecialties. METHODS: This was a retrospective single-institution cohort study of pediatric fellows beginning fellowship training between July 2016 and July 2019. De-identified Milestone score sets for final residency scores (R), mid-year first-year fellowship scores (F1), and final first-year fellowship scores (F2) were collected. Spearman correlation and regression analyses were used to assess score relationships. RESULTS: Data for 85 of 98 eligible fellows were collected. Consistently, the F1 scores were lowest, and the R scores were highest. There was a weak positive correlation between the composite R scores and the composite F1 scores. There was a weak positive correlation between residency and fellowship scores for 6 CSCs and no significant correlation for the remaining 5. CONCLUSION: For the 11 pediatric CSCs, the final residency Milestone scores are consistently higher than and only weakly associated with early fellowship Milestone scores. There may be limitations to the use of residency scores for fellowship program directors in guiding individualized education for early fellows. This study provides groundwork for additional study of Milestone relationships and may help inform the next iteration of pediatric subspecialty Milestones.

Utilizing a Quality Improvement Strategy to Increase Faculty Engagement With Resident Learning Goals.

BACKGROUND: Establishing and achieving learning goals (LGs) are important lifelong learning skills for residents. Faculty are critical in facilitation and achievement of residents' LGs, yet many have difficulty with this role in the busy inpatient setting. OBJECTIVES: Our primary aim was to improve faculty engagement in resident LGs, targeting ≥80% of faculty achieving a mean score ≥goal, over a period of 1 year by setting prerotation expectations and stressing team-based faculty accountability during the rotation in the current inpatient learning environment. METHODS: We identified key barriers to addressing LGs on an inpatient subspecialty service. Key interventions included 1) introducing LGs to faculty, 2) establishing a communication/handover process among faculty, 3) LGs development, and 4) tracking accountability. Baseline mean faculty milestone scores were determined from the prior year. Over 1 year, we developed and refined a system for residents to create and document LGs with faculty oversight and review. We reviewed faculty evaluations quarterly to measure progress and reviewed rotation evaluations. RESULTS: Faculty engagement with LGs improved through the course of the academic year. All but one faculty member had improved LGs scores during the intervention year. Most residents were very satisfied with the intervention and gave unprompted favorable feedback on rotation evaluations. The majority of submitted LGs were either partially or completely addressed. CONCLUSIONS: We demonstrated that a quality improvement approach to a faculty educational skill is feasible and effective. Our intervention related to LGs may be modified for any medical learner in any inpatient or outpatient setting.

Thematic analysis comparing stressors for pediatric residents and subspecialty fellows at a large children's hospital.

INTRODUCTION: Pediatric residents and subspecialty fellows experience a significant number of stressors during training, but they have rarely been self-reported or compared between groups. This qualitative study aimed to identify and compare themes of stressors experienced by pediatric residents and subspecialty fellows at a single large children's hospital. MATERIALS AND METHODS: Using an open-ended survey at single time point for each group, we asked residents and fellows to list the stressors they face in training. The survey data was iteratively analyzed using thematic analysis then quantified by its frequency in each group and compared using a chi-square distribution or a Fisher's exact test, as appropriate. RESULTS: Twenty-eight of 159 residents (18%) and 38 of 180 fellows (21%) answered the survey question, and an average of 2.8 stressors were identified by each resident and fellow. Two major themes and five major subthemes were shared between both groups. The theme Stressors at Home included the subthemes Difficulty Maintaining Overall Health and External Stressors. The theme Stressors at Work encompassed the subthemes Clinical Stressors Innate to Patient Care, Demanding Workload and Schedule, and Stressors Related to Culture of Work Environment. Within the subthemes, there were differences in categories of stressors between the groups. While there was no statistically significant difference in the distribution of themes, subthemes, or categories of stressors mentioned between groups, in general residents identified stressors associated with lack of autonomy and control whereas fellows focused on clinical uncertainty and complex situations. CONCLUSIONS: While residents and fellows shared similar themes and subthemes for stressors, there was variability between individual categories. This study identified individual self-reported stressors that can be used by programs to design interventions to improve trainee well-being, but it also implies that programmatic support at different levels of training should be tailored to the target group.KEY MESSAGEAt our hospital, we found that some self-reported stressors facing pediatric residents and fellows were common and some unique.Stressors included those that can be eliminated or diminished as well as those that cannot.With knowledge that these disparities exist, training programs should use unique strategies to provide support for the two groups and their stressors.

Sedation Practices for Lumbar Punctures in Patients With Acute Lymphoblastic Leukemia: A Multicenter Retrospective Study Using Pediatric Health Information Systems.

BACKGROUND: Sedation is often used to reduce pain and anxiety in pediatric patients with acute lymphoblastic leukemia (ALL) undergoing lumbar punctures (LPs). There is a potential for long-term effects on neurocognition with repeat sedative exposures in young children. The purpose of this study is to determine the practice habits regarding sedation for LPs in pediatric patients with ALL among multiple institutions. METHODS: This is a retrospective study of 48 hospitals in the Pediatric Health Information Systems (PHIS) between October 2015 and December 2019. Children 1 to 18 years old with ALL who received intrathecal chemotherapy in an outpatient setting were included. We analyzed the prevalence of anesthesia usage and the types of anesthetics used. RESULTS: Of the 16,785 encounters with documented use of anesthetic medications, intravenous and inhaled anesthetics were used in 16,486 (98.2%) and local anesthetics alone in 299 (1.8%). The most commonly used medications used for sedation were propofol (n=13,279; 79.1%), midazolam (n=4228; 25.2%), inhaled fluranes (n=3169; 18.9%), and ketamine (n=2100; 12.5%). CONCLUSION: The majority of children's hospitals in the United States use intravenous and inhaled anesthetics for routine therapeutic LPs in pediatric patients with ALL. Propofol is one of the most common medications used for sedation.

Extent of hypertension and renal injury in children surviving acute lymphoblastic leukemia.

BACKGROUND: Childhood acute lymphoblastic leukemia (ALL) fortunately has high survival rates, and understanding longer term implications of therapy is critical. In this study, we aimed to investigate kidney health outcomes by assessing the prevalence of renal dysfunction and hypertension (HTN) in children with ALL at 1-5 years after ALL diagnosis. METHODS: This was a single-center, cross-sectional study of children with ALL who were 1-5 years post diagnosis. Glomerular filtration rate (GFR) measurements were calculated, and urine samples were collected to assess for protein/creatinine and albumin/creatinine. Blood pressure (BP) was determined by standard oscillometric technique, and children ≥6 years of age were eligible for ambulatory blood pressure monitoring (ABPM). RESULTS: Forty-five patients enrolled in the study, and 21 completed ABPMs. Fifteen patients (33%, 95% CI: 20%-49%) developed acute kidney injury (AKI) at least once. Thirteen (29%, 95% CI: 16%-44%) had hyperfiltration, and 11 (24%) had abnormal proteinuria and/or albuminuria. Prevalence of HTN based on clinic measurements was 42%. In the 21 ABPM patients, 14 had abnormal results (67%, 95% CI: 43%-85%), with the majority (11/21) demonstrating abnormal nocturnal dipping pattern. CONCLUSIONS: Among children with ALL, there is a high prevalence of past AKI. The presence of hyperfiltration, proteinuria, and/or albuminuria at 1-5 years after ALL diagnosis suggests real risk of developing chronic kidney disease (CKD) over time. There is a high prevalence of HTN on casual BP readings and even higher prevalence of abnormal ABPM in this group. The high prevalence of impaired nocturnal dipping by ABPM indicates an increased risk for future cardiovascular or cerebral ischemic events.

Defining kidney outcomes in children with acute lymphoblastic leukemia in the modern era.

BACKGROUND: To define the incidence of acute kidney injury (AKI), chronic kidney disease (CKD), and hypertension (HTN) in pediatric patients diagnosed with acute lymphoblastic leukemia (ALL) over a recent 9-year period. METHODS: This study is a retrospective cohort study of all pediatric patients diagnosed with ALL at Nationwide Children's Hospital from January 1, 2008, to December 31, 2016. Patient demographic and clinical data including serum creatinine and blood pressure were collected at diagnosis up to 9 years post diagnosis. RESULTS: A total of 222 patients were identified for this study. The overall incidence of AKI in our cohort was high, with 101 subjects (45.5%, CI 38.8-52.3%) developing AKI at least once. CKD status could only be determined in 214 patients due to limited later GFR data. The incidence of CKD was low with only 5 of 214 patients developing CKD (2.3%, CI: 0.8-5.4%). The overall incidence of HTN at diagnosis was 45.6% (95% CI: 59.1-72%), and at 1 month post diagnosis was 65.8% (95% CI: 59.1-72.0%). Chronic HTN could only be determined in 216 patients due to limited blood pressure data. Chronic HTN was noted in 34.3% of patients (74/216, 95% CI: 28-41%). CONCLUSIONS: Among children with ALL, the incidence of AKI is relatively high at the time of diagnosis. However, development of CKD is relatively rare, suggesting good mid-term kidney prognosis. There is a high incidence of HTN at the time of diagnosis, 1 month post diagnosis, and chronic HTN that often goes untreated. A higher resolution version of the Graphical abstract is available as Supplementary information.

Advanced Multimodal Communication Curriculum for Pediatric Residents.

BACKGROUND: Medical educators juggle competing demands as they seek to integrate medical advancements and new technology with the call for earlier introduction to clinical experiences. Newer models of medical education place even greater emphasis on the importance of deliberate training of providers who can deliver compassionate patient-centered care. The need for adaptable, effective communication skills training has never been more relevant than now, in our high-tech and ever-evolving learning climate. METHODS: At a large pediatric academic center, we used Kern's six-step approach to complete a needs assessment, identify goals and learning preferences of trainees, and ultimately develop and evaluate a multimodal communication curriculum. This curriculum was rooted in the Accreditation Council for Graduate Medical Education's Pediatric Milestones, with the goal of enhancing knowledge, skills, and competency. Pediatric interns were randomized to either the new curriculum (n = 19) or the existing didactic-based communication training (n = 17) from 2019 to 2020. We evaluated the impact of the new and traditional curriculum through evaluations by expert facilitators, learner surveys, and faculty-assigned resident milestones. RESULTS: Many trainees self-identified performance gaps in communication skills at baseline. Eighteen residents attended 1 to 6 in-person deliberate practice workshops. Workshop participation by the residents varied over time due to a variety of factors. All residents, regardless of curricular exposure, showed statistically significant improvement in communication milestones from first to second year and those enrolled in the deliberate practice curriculum highly valued the workshops and coaching. DISCUSSION: Our curriculum demonstrates the value of deliberate practice opportunities for residents to gain skills in advanced communication. Residents appreciated this type of training and the time devoted to expand these skills. Lessons learned and barriers to implementation from this curriculum can be helpful for educators interested in integrating active, deliberate practice, simulation-based communication training into their current educational model.

Unintended pregnancy in users of nomegestrol acetate and 17ß-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study.

OBJECTIVE: To assess and compare the risk of unintended pregnancy in NOMAC-E2 users with levonorgestrel-containing COC (COCLNG) users in clinical practice. STUDY DESIGN: In this observational study, new users1 of NOMAC-E2 and COCLNG were recruited in Europe, Australia, and Latin America and followed for up to 2 years. Unintended pregnancy was expressed by the Pearl Index (contraceptive failures per 100 women-years [WY]), crude hazard ratios (HRcrude) and adjusted hazard ratios (HRadj). RESULTS: Overall, 44,559 and 46,754 users were recruited to the NOMAC-E2 and COCLNG user cohorts, respectively. There were 64 unintended pregnancies in NOMAC-E2 users (0.15 per 100 WY; 95% CI, 0.11-0.19) and 200 in COCLNG users (0.41 per 100 WY; 95% CI, 0.35-0.47). The unintended pregnancy risk was statistically significantly lower in the NOMAC-E2 cohort (p<.0001) compared to the COCLNG user cohort. The HRadj of NOMAC-E2 vs COCLNG was 0.45 (95% CI, 0.34-0.60; adjusted for age, body mass index, gravidity, COC user status, education level). CONCLUSIONS: NOMAC-E2 demonstrated superior contraceptive effectiveness compared to COCLNG, likely due to the comparatively short hormone-free interval and possibly reinforced by the long half-life of NOMAC.

Prospective controlled cohort study on the safety of a monophasic oral contraceptive containing nomegestrol acetate (2.5mg) and 17ß-oestradiol (1.5mg) (PRO-E2 study): risk of venous and arterial thromboembolism.

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.

Family-centered communication: A pilot educational intervention using deliberate practice and patient feedback.

OBJECTIVE: There are few opportunities in medical education dedicated to learning skills for effective communication in life altering patient scenarios. We therefore aimed to develop and assess a longitudinal advanced communication curriculum for pediatric residents using patient feedback and deliberate practice. METHODS: Pediatric residents at a large academic center were randomized into 2 groups. The intervention group received 6 educational sessions from 2019 to 2020, parent feedback of performance via the Communication Assessment Tool (CAT), and monthly communication tips. Communication skills of both groups were assessed at the end of the intervention. RESULTS: We collected 937 CAT assessments on 36 first-year residents. The intervention group demonstrated statistically significant improvement in communication skills from pre to post assessment (p = 0.0063, (odds ratio (OR) 1.76, 95 % confidence interval (CI) [1.17, 2.63]) compared to the control group (p = 0.080, OR 1.41, 95 % CI [0.96, 2.05]). CONCLUSIONS: There are patient and self-identified performance gaps in communication skills for pediatric residents, underscoring the need for formalized curricula dedicated to these skills. PRACTICE IMPLICATIONS: Our study highlights the value of deliberate practice and the integration of family feedback as an educational tool in communication skills development.

Describing Overarching Curricular Goals for Individualized Education.

Phenomenon: The phenomenon of individualized education, an essential component of competency-based medical education, addresses individual learner needs while working toward standardized learning outcomes. One challenge with broadly implementing individualized education is the lack of a pragmatic operational definition. To formalize expectations for individualized education, the Accreditation Council of Graduate Medical Education in 2013 began requiring six months of individualized curriculum (IC) during pediatric residency; however, there is not a national standard of formal curricular goals for the IC as an educational entity. Examining and describing the overarching curricular goals of IC could provide a framework for discourse about and further study of individualized education in medicine across disciplines and the continuum of medical education. Thus, we aimed to describe the phenomenon of individualized education through the lens of the goals of the IC in pediatric residency in the United States. Approach: In 2017, a purposeful sample of Pediatric Residency leaders were recruited to represent a diverse sample of program sizes, regions of the country, and importance of the IC to the program leadership. They completed an online survey with open-ended questions describing formal and implicit goals of their program's IC. The authors analyzed responses initially using conventional content analysis, then investigated whether the themes for program goals aligned with any existing educational theory. The concepts and language aligned with the principles of self-determination theory (SDT); therefore, the IC goals were subsequently grouped using the SDT domains of relatedness, autonomy, and competence. A focus group with a subset of survey respondents was conducted for member checking and elaboration of concepts. Findings: Program leaders from a diverse sample of 36 programs participated in the survey and a subset of 11 programs participated in the focus group. The common goals across all programs are listed in parentheses and organized by domains of SDT: 1)Relatedness goals (engage in mentorship, select a career) cultivate resident's professional identity based on their desired future career path; 2)autonomy goals (create a learning plan, practice accountability) help residents plan their path; and fulfillment of their plans lead to 3)competence goals (develop targeted clinical skills and knowledge, ensure comprehensive exposure, address learning gaps), ensuring they have a comprehensive skill set for their chosen identity. Insights: This study provides a framework to describe the phenomenon of individualized education through the lens of IC curricular goals in pediatric residency. The goals for IC that emerged from this study serve as a pragmatic framework for implementation of individualized education. They provide a common language and structure to promote more rigorous and collaborative study of individualized education across programs, disciplines, and settings in medicine. They may function as a roadmap for learners to navigate educational activities and for programs to help shape the experiences of their learners and examine outcomes of individualized education in their programs. The framework can also help individual pediatric residency programs structure improvements to their IC. Disciplines beyond pediatrics may also use this framework to better structure elective experiences to capitalize on the benefits of individual education.

Exploring Pediatric Resident Attitudes and Preferences for Board Exam Preparation.

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.