Implementing Entrustable Professional Activities in Pediatric Fellowships: Facilitating the Process.

BACKGROUND AND OBJECTIVES: Entrustable professional activities (EPAs) will be used for initial certification by the American Board of Pediatrics by 2028. Less than half of pediatric fellowships currently use EPAs for assessment, yet all will need to adopt them. Our objectives were to identify facilitators and barriers to the implementation of EPAs to assess pediatric fellows and to determine fellowship program directors' (FPD) perceptions of EPAs and Milestones. METHODS: We conducted a survey of FPDs from 15 pediatric subspecialties. EPA users were asked about their implementation of EPAs, barriers encountered, and perceptions of EPAs. Nonusers were queried about deterrents to using EPAs. Both groups were asked about potential facilitators of implementation and their perceptions of Milestones. RESULTS: The response rate was 65% (575/883). Of these, 344 (59.8%) were EPA users and 231 (40.2%) were nonusers. Both groups indicated work burden as a barrier to implementation. Nonusers reported more barriers than users (mean [SD]: 7 [3.8] vs 5.8 [3.4], P < .001). Both groups identified training materials and premade assessment forms as facilitators to implementation. Users felt that EPAs were easier to understand than Milestones (89%) and better reflected what it meant to be a practicing subspecialty physician (90%). In contrast, nonusers felt that Milestones were easy to understand (57%) and reflected what it meant to be a practicing subspecialist (58%). CONCLUSIONS: Implementing EPA-based assessment will require a substantial investment by FPDs, facilitated by guidance and easily accessible resources provided by multiple organizations. Perceived barriers to be addressed include FPD time constraints, a need for additional assessment tools, and outcomes data.

Optimizing therapeutic decision-making for off-label medicines use: A scoping review and consensus recommendations for improving practice and research.

PURPOSE: Off-label medicines use is a common and sometimes necessary practice in many populations, with important clinical, ethical and financial consequences, including potential unintended harm or lack of effectiveness. No internationally recognized guidelines exist to aid decision-makers in applying research evidence to inform off-label medicines use. We aimed to critically evaluate current evidence informing decision-making for off-label use and to develop consensus recommendations to improve future practice and research. METHODS: We conducted a scoping review to summarize the literature on available off-label use guidance, including types, extent and scientific rigor of evidence incorporated. Findings informed the development of consensus recommendations by an international multidisciplinary Expert Panel using a modified Delphi process. Our target audience includes clinicians, patients and caregivers, researchers, regulators, sponsors, health technology assessment bodies, payers and policy makers. RESULTS: We found 31 published guidance documents on therapeutic decision-making for off-label use. Of 20 guidances with general recommendations, only 35% detailed the types and quality of evidence needed and the processes for its evaluation to reach sound, ethical decisions about appropriate use. There was no globally recognized guidance. To optimize future therapeutic decision-making, we recommend: (1) seeking rigorous scientific evidence; (2) utilizing diverse expertise in evidence evaluation and synthesis; (3) using rigorous processes to formulate recommendations for appropriate use; (4) linking off-label use with timely conduct of clinically meaningful research (including real-world evidence) to address knowledge gaps quickly; and (5) fostering partnerships between clinical decision-makers, researchers, regulators, policy makers, and sponsors to facilitate cohesive implementation and evaluation of these recommendations. CONCLUSIONS: We provide comprehensive consensus recommendations to optimize therapeutic decision-making for off-label medicines use and concurrently drive clinically relevant research. Successful implementation requires appropriate funding and infrastructure support to engage necessary stakeholders and foster relevant partnerships, representing significant challenges that policy makers must urgently address.

Clinical competency committee perceptions of entrustable professional activities and their value in assessing fellows: A qualitative study of pediatric subspecialty program directors.

OBJECTIVES: To examine the composition and processes of Clinical Competency Committees (CCCs) assigning entrustable professional activity (EPA) levels of supervision for pediatric subspecialty fellows and to examine fellowship program director (FPD) perspectives about using EPAs to determine fellows' graduation readiness. METHODS: A qualitative study was performed using one-on-one interviews with a purposeful sample of pediatric subspecialty FPDs to yield a thematic analysis. Semi-structured interview guides were used for participants who self-identified as EPA users or non-users. Inductive analysis and coding were performed on transcripts until theoretical sufficiency was attained. RESULTS: Twenty-eight FPDs were interviewed. There was significant variability in the composition and processes of CCCs across subspecialties. FPDs felt that CCCs intuitively understand what entrustment means, allowing for ease of application of level of supervision (LOS) scales and consensus. FPDs perceived that EPAs provided a global assessment of fellows and are one tool to determine graduation readiness. CONCLUSIONS: Although there was variability in the makeup and processes of CCCs across subspecialties, FPDs believe EPAs are intuitive and relatively easy to implement. Consensus can be reached easily using EPA-specific LOS scales focusing on entrustment. FPDs desire a better understanding of how EPAs should be used for graduation.

Transport Medical Control Education for Pediatric Critical Care Fellows: A National Needs Assessment Study.

OBJECTIVES: Characterize transport medical control education in Pediatric Critical Care Medicine fellowship. DESIGN: Cross-sectional survey study. SETTING: Pediatric Critical Care Medicine fellowship programs in the United States. SUBJECTS: Pediatric Critical Care Medicine fellowship program directors. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We achieved a 74% (53/72) response rate. A majority of programs (85%) require fellows to serve as transport medical control, usually while carrying out other clinical responsibilities and sometimes without supervision. Fellows at most programs (80%) also accompany the transport team on patient retrievals. Most respondents (72%) reported formalized transport medical control teaching, primarily in a didactic format (76%). Few programs (25%) use a standardized assessment tool. Transport medical control was identified as requiring all six Accreditation Council for Graduate Medical Education competencies, with emphasis on professionalism and interpersonal and communication skills. CONCLUSIONS: Transport medical control responsibilities are common for Pediatric Critical Care Medicine fellows, but training is inconsistent, assessment is not standardized, and supervision may be lacking. Fellow performance in transport medical control may help inform assessment in multiple domains of competencies. Further study is needed to identify effective methods for transport medical control education.

Establishing the Knowledge and Skills Necessary in Pediatric Critical Care Medicine: A Systematic Approach to Practice Analysis.

OBJECTIVES: To describe the practice analysis undertaken by a task force convened by the American Board of Pediatrics Pediatric Critical Care Medicine Sub-board to create a comprehensive document to guide learning and assessment within Pediatric Critical Care Medicine. DESIGN: An in-depth practice analysis with a mixed-methods design involving a descriptive review of practice, a modified Delphi process, and a survey. SETTING: Not applicable. SUBJECTS: Seventy-five Pediatric Critical Care Medicine program directors and 2,535 American Board of Pediatrics Pediatric Critical Care Medicine diplomates. INTERVENTIONS: A practice analysis document, which identifies the full breadth of knowledge and skill required for the practice of Pediatric Critical Care Medicine, was developed by a task force made up of seven pediatric intensivists and a psychometrician. The document was circulated to all 75 Pediatric Critical Care Medicine fellowship program directors for review and comment and their feedback informed modifications to the draft document. Concurrently, data from creation of the practice analysis draft document were also used to update the Pediatric Critical Care Medicine, was developed by a task force made up of seven pediatric intensivists and a psychometrician. The document was circulated to all 75 Pediatrics Pediatric Critical Care Medicine fellowship program directors for review and comment and their feedback informed modifications to the draft document. Concurrently, data from creation of the practice analysis draft document were also used to update the Pediatric Critical Care Medicine content outline, which was sent to all 2,535 American Board of Pediatrics Pediatric Critical Care Medicine diplomates for review during an open-comment period between January 2019 and February 2019, and diplomate feedback was used to make updates to both the content outline and the practice analysis document. MEASUREMENTS AND MAIN RESULTS: After review and comment by 25 Pediatric Critical Care Medicine program directors (33.3%) and 619 board-certified diplomates (24.4%), a comprehensive practice analysis document was created through a two-stage process. The final practice analysis includes 10 performance domains which parallel previously published Entrustable Professional Activities in Pediatric Critical Care Medicine. These performance domains are made up of between three and eight specific tasks, with each task including the critical knowledge and skills that are necessary for successful completion. The final practice analysis document was also used by the American Board of Pediatrics Pediatric Critical Care Medicine Sub-board to update the Pediatric Critical Care Medicine content outline. CONCLUSIONS: A systematic approach to practice analysis, with stakeholder engagement, is essential for an accurate definition of Pediatric Critical Care Medicine practice in its totality. This collaborative process resulted in a dynamic document useful in guiding curriculum development for training programs, maintenance of certification, and lifetime professional development to enable safe and efficient patient care.

Expanding Faculty Development of Teaching Skills: A National Needs Assessment of Pediatric Critical Care Medicine Faculty.

OBJECTIVES: High-quality clinical teaching is an essential element in preparing trainees to become independently competent clinicians. In order to better understand the context-specific faculty development needs of teaching faculty in a specific community, we sought to determine the self-reported teaching skill deficits of pediatric critical care medicine faculty and their preferences and motivations regarding faculty development to enhance their teaching. DESIGN: Modified Delphi technique was used to create an online survey in which respondents rated their need for education on a variety of teaching skills, their preferred learning modalities, and factors that motivate their participation in faculty development. SETTING: Pediatric Critical Care Medicine divisions at the 64 sites in the United States with fellowship programs. SUBJECTS: Five-hundred forty-five Pediatric Critical Care Medicine faculty who teach fellows and other trainees. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Response rate was 40%. Respondents reported a median of 8.5 years (interquartile range, 4-16 yr) as teaching faculty. The median age of faculty was 44.6 years (interquartile range, 38-50 yr). Only 20% of respondents indicated that improving their teaching was a low priority. Thirty-six percent of respondents had not participated in any formal teaching skill development as faculty. The most frequently cited factors motivating engagement in faculty development were education being included as part of regularly attended conferences, resources readily available when needed, and participation promoted by a supervisor. Preferred learning modalities included a brief discussion with a colleague, a 10-minute video, and a regular conference series. CONCLUSIONS: Pediatric Critical Care Medicine faculty reported they experience challenges in teaching and would benefit from faculty development training aimed at improving their knowledge and skills about being an educator. Preferred learning methods and motivating factors highlight the importance of efficiency in content delivery and endorsement by faculty supervisors. Consideration of these needs and preferences may be useful in creating context-focused, community of practice-based faculty development programs.

Unscheduled readmissions to the PICU: epidemiology, risk factors, and variation among centers.

OBJECTIVES: To determine the rate of, and potential risk factors for, unscheduled PICU readmission and assess for variability among PICUs within the United States. DESIGN AND DATA SOURCE: This retrospective cohort study used 2005-2008 data from 73 PICUs in the Virtual PICU Systems database. METHODS AND MEASUREMENTS: Early (within 48 hr of PICU discharge) and late (later than 48 hr) unscheduled readmission rates were calculated. Hierarchical logistic regression, with a random intercept for site, was used to identify factors independently associated with early readmission. Significant random effects identified sites with an outlying risk of readmission, adjusting for patient and admission characteristics. MAIN RESULTS: For 117,923 children meeting inclusion criteria, the unscheduled readmission rate was 3.7% with 38% (1.4%) occurring early. Half of early readmissions had the same primary diagnosis as the first admission. Patients with late readmissions had a higher mortality (6.6% vs 3.3%, p < 0.001) and longer median total PICU length of stay (11 d vs 6 d, p < 0.0001) than those with early readmission. Patient characteristics strongly associated with increased risk of early readmission included the following: age < 6 months, acute respiratory and renal disease, and several underlying chronic conditions such as liver disease, bone marrow transplant, airway stenosis, and abnormal antidiuretic hormone balances. An initial PICU admission that was unscheduled, originated from the general floor, or with a discharge time between 4 PM and 8 AM was associated with higher risk of readmission. A quarter of sites were identified as potential high (16%) or low (8%) outliers. CONCLUSIONS: The rate of unscheduled PICU readmission was low but associated with worse outcomes. Patient and admission/discharge characteristics associated with increased risk of readmissions could be used to target high-risk populations or modifiable factors to improve outcome. Variation of risk among centers suggests room for improvement.

Comparative safety of selective serotonin reuptake inhibitors among pediatric users with respect to adverse cardiac events.

PURPOSE: This study aims to perform a comparative safety study assessing the risk of ventricular arrhythmia, cardiac arrest, or sudden death among pediatric selective serotonin reuptake inhibitor (SSRI) users. METHODS: Using US claims data from 1997 to 2009, new pediatric (age < 18 years) users of SSRI monotherapy were identified. Adverse cardiac outcomes occurring within 12 months of SSRI initiation were identified using a previously validated International Classification of Disease, ninth edition algorithm. Cox proportional hazard analysis was used to estimate the risk for each SSRI, using fluoxetine as the referent group, adjusting for the propensity to receive an individual SSRI, demographics, and exposure covariates. RESULTS: Over the study period, 113,714 subjects met the inclusion criteria and contributed 40,639 person-years of SSRI exposure time. Sertraline (33%) and fluoxetine (29%) were the most commonly prescribed SSRIs. Forty events occurred within 12 months of SSRI initiation. The crude incidence rate was highest for escitalopram (19.5/10,000 person-years) and lowest for fluoxetine (4.2/10,000 person-years). The median time to event ranged from 45 to 86 days. The adjusted risk of adverse event, relative to fluoxetine, was highest for citalopram Hazard Ratio (HR) = 3.53, 95% confidence interval [CI] = 1.09­11.46) and escitalopram (HR = 3.30, 95%CI = 1.08­10.14) and lowest for paroxetine (HR = 1.34, 95%CI = 0.30­5.99) and sertraline (HR = 2.14, 95%CI = 0.75­6.16). CONCLUSIONS: The incidence of adverse cardiac events among pediatric SSRI users was low. However, the risk of an adverse outcome was higher for citalopram and escitalopram users as compared with fluoxetine users. Future studies should focus on confirming these findings and identifying modifying risk factors to optimize medication selection for this population.

Off-label antidepressant use in children and adolescents compared with young adults: extent and level of evidence.

PURPOSE: To estimate the degree of, and level of evidence supporting, off-label antidepressant (AD) prescribing for children and adolescents compared with young adults. METHODS: Retrospective cohort study utilizing medical and pharmacy claims data from US-managed care plans, 1997-2009. PARTICIPANTS: Patients aged 5-24 years, with at least one (index) AD claim during a period of continuous enrollment. MAIN OUTCOME MEASURES: Drug-diagnosis pairs, on the basis of medical claims within 30 days pre-index or post-index AD, were grouped as (1) Food and Drug Administration (FDA)-approved or (2) off-label with one of three evidence categories based on Micromedex®2.0: favorable, inconclusive or limited-to-none (Thomson Micromedex, Greenwood Village, CO, USA). RESULTS: Over the study period, 290 816 subjects met eligibility criteria: 17% 5-12 years old, 40% 13-18 years old, and 43% 19-24 years old. Sertraline was the most commonly prescribed index AD (19-23%). Psychiatrists more often prescribed the AD for children (31%) and adolescents (35%) versus young adults (17%). Only 28% of all subjects had a diagnosis consistent with an FDA-approved indication within 30 days pre-index and post-index AD. Children less than 13 years old were less likely to have had an FDA-approved indication (5-10%). Most off-label prescribing had inconclusive to no evidence supporting efficacy. The lack of evidence was especially pronounced for younger children. Trends were consistent over the study period. Increasing the time period for potential indications pre-index and post-index AD did not result in significantly reduced off-label rates. CONCLUSIONS: Pediatric off-label AD prescribing occurs frequently without a strong evidence base, highlighting a need to generate additional evidence to ensure safe and effective use.