Optimizing Professional Practice Evaluation to Enable a Nonpunitive Learning Health System Approach to Peer Review.

Healthcare organizations are focused on 2 different and sometimes conflicting tasks; (1) accelerate the improvement of clinical care delivery and (2) collect provider-specific data to determine the competency of providers. We describe creating a process to meet both of these aims while maintaining a culture that fosters improvement and teamwork. METHODS: We created a new process to sequester activities related to learning and improvement from those focused on individual provider performance. We describe this process, including data on the number and type of cases reviewed and survey results of the participant's perception of the new process. RESULTS: In the new model, professional practice evaluation committees evaluate events purely to identify system issues and human factors related to medical decision-making, resulting in actional improvements. There are separate and sequestered processes that evaluate concerns around an individual provider's clinical competence or behavior. During the first 5 years of this process, 207 of 217 activities (99.5%) related to system issues rather than issues concerning individual provider competence or behavior. Participants perceived the new process as focused on identifying system errors (4.3/5), nonpunitive (4.2/5), an improvement (4.0/5), and helped with engagement in our system and contributed to wellness (4.0/5). CONCLUSION: We believe this sequestered approach has enabled us to achieve both the oversight mandates to ensure provider competence while enabling a learning health systems approach to build the cultural aspects of trust and teamwork that are essential to driving continuous improvement in our system of care.

A Multifaceted Mentoring Program for Junior Faculty in Academic Pediatrics.

PROBLEM: The departure of physician-scientists from education and research into clinical practice is a growing challenge for the future of academic medicine. Junior faculty face competing demands for clinical productivity, teaching, research, and work-life integration, which can undermine confidence in the value of an academic career. Mentorship is important to foster career development and satisfaction in junior faculty. INTERVENTION: The goals of this academic pediatrics department were to develop, implement, and evaluate a multifaceted pediatric mentoring program to promote retention and satisfaction of junior faculty. Program elements included one-on-one mentor-mentee meetings, didactic workshops, grant review assistance, and facilitated peer-group mentoring. Program effectiveness was assessed using annual surveys of mentees and structured mentee exit interviews, as well as retention data for assistant professors. CONTEXT: The mentees were instructors and assistant professors in the department of pediatrics. OUTCOME: Seventy-nine mentees participated in the program from 2007 through 2014. The response rate from seven annual surveys was 84%. Sixty-nine percent of mentees felt more prepared to advance their careers, 81% had a better understanding of the criteria for advancement, 84% were satisfied with the program, and 95% found mentors accessible. Mentees who exited the program reported they most valued the one-on-one mentoring and viewed the experience positively regardless of promotion. Retention of assistant professors improved after initiation of the program; four of 13 hired from 2002 to 2006 left the institution, whereas 18 of 18 hired from 2007 to 2014 were retained. LESSONS LEARNED: This multifaceted mentoring program appeared to bolster satisfaction and enhance retention of junior pediatric faculty. Mentees reported increased understanding of the criteria for promotion and viewed the program as a positive experience regardless of career path. Individual mentor-mentee meetings were needed at least twice yearly to establish the mentoring relationship. Identifying "next steps" at the end of individual meetings was helpful to hold both parties accountable for progress. Mentees most valued workshops fostering development of tangible skills (such as scientific writing) and those clarifying the criteria for promotion more transparent. Facilitated peer-group mentoring for mentees at the instructor rank provided valuable peer support.

Randomized, double-blind, placebo-controlled trial of the efficacy and safety of rilonacept in the treatment of systemic juvenile idiopathic arthritis.

OBJECTIVE: To assess the efficacy and safety of rilonacept, an interleukin-1 inhibitor, in a randomized, double-blind, placebo-controlled trial. METHODS: An initial 4-week double-blind placebo phase was incorporated into a 24-week randomized multicenter design, followed by an open-label phase. Seventy-one children who had active arthritis in ≥2 joints were randomized (1:1) to the 2 arms of the study. Patients in the rilonacept arm received rilonacept (loading dose 4.4 mg/kg followed by 2.2 mg/kg weekly, subcutaneously) beginning on day 0. Patients in the placebo arm received placebo for 4 weeks followed by a loading dose of rilonacept at week 4 followed by weekly maintenance doses. The primary end point was time to response, using the adapted American College of Rheumatology Pediatric 30 criteria coupled with the absence of fever and taper of the dosage of systemic corticosteroids, using prespecified criteria. RESULTS: The time to response was shorter in the rilonacept arm than in the placebo arm (χ(2) = 7.235, P = 0.007). The secondary analysis, which used the same response criteria, showed that 20 (57%) of 35 patients in the rilonacept arm had a response at week 4 compared with 9 (27%) of 33 patients in the placebo arm (P = 0.016). Exacerbation of systemic juvenile idiopathic arthritis (JIA) was the most common severe adverse event. More patients in the rilonacept arm had elevated liver transaminase levels (including levels more than 3 times the upper limit of normal) compared with those in the placebo arm. Adverse events were similar in the 2 arms of the study. CONCLUSION: Rilonacept was generally well tolerated and demonstrated efficacy in active systemic JIA.

Secondary analysis of APPLE study suggests atorvastatin may reduce atherosclerosis progression in pubertal lupus patients with higher C reactive protein.

OBJECTIVE: Participants in the Atherosclerosis Prevention in Paediatric Lupus Erythematosus (APPLE) trial were randomised to placebo or atorvastatin for 36 months. The primary endpoint, reduced carotid intima medial thickness (CIMT) progression, was not met but atorvastatin-treated participants showed a trend of slower CIMT progression. Post-hoc analyses were performed to assess subgroup benefit from atorvastatin therapy. METHODS: Subgroups were prespecified and defined by age (> or ≤15.5 years), systemic lupus erythematosus (SLE) duration (> or ≤24 months), pubertal status (Tanner score≥4 as post-pubertal or <4 as pre-pubertal), low density lipoprotein cholesterol (LDL) (≥ or <110 mg/dl) and high-sensitivity C reactive protein (hsCRP) (≥ or <1.5 mg/l). A combined subgroup (post-pubertal and hsCRP≥1.5 mg/l) was compared to all others. Longitudinal linear mixed-effects models were developed using 12 CIMT and other secondary APPLE outcomes (lipids, hsCRP, disease activity and damage, and quality of life). Three way interaction effects were assessed for models. RESULTS: Significant interaction effects with trends of less CIMT progression in atorvastatin-treated participants were observed in pubertal (3 CIMT segments), high hsCRP (2 CIMT segments), and the combined high hsCRP and pubertal group (5 CIMT segments). No significant treatment effect trends were observed across subgroups defined by age, SLE duration, LDL for CIMT or other outcome measures. CONCLUSIONS: Pubertal status and higher hsCRP were linked to lower CIMT progression in atorvastatin-treated subjects, with most consistent decreases in CIMT progression in the combined pubertal and high hsCRP group. While secondary analyses must be interpreted cautiously, results suggest further research is needed to determine whether pubertal lupus patients with high CRP benefit from statin therapy. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT00065806.

Using registries to identify adverse events in rheumatic diseases.

The proven effectiveness of biologics and other immunomodulatory products in inflammatory rheumatic diseases has resulted in their widespread use as well as reports of potential short- and long-term complications such as infection and malignancy. These complications are especially worrisome in children who often have serial exposures to multiple immunomodulatory products. Post-marketing surveillance of immunomodulatory products in juvenile idiopathic arthritis (JIA) and pediatric systemic lupus erythematosus is currently based on product-specific registries and passive surveillance, which may not accurately reflect the safety risks for children owing to low numbers, poor long-term retention, and inadequate comparators. In collaboration with the US Food and Drug Administration (FDA), patient and family advocacy groups, biopharmaceutical industry representatives and other stakeholders, the Childhood Arthritis and Rheumatology Research Alliance (CARRA) and the Duke Clinical Research Institute (DCRI) have developed a novel pharmacosurveillance model (CARRA Consolidated Safety Registry [CoRe]) based on a multicenter longitudinal pediatric rheumatic diseases registry with over 8000 participants. The existing CARRA infrastructure provides access to much larger numbers of subjects than is feasible in single-product registries. Enrollment regardless of medication exposure allows more accurate detection and evaluation of safety signals. Flexibility built into the model allows the addition of specific data elements and safety outcomes, and designation of appropriate disease comparator groups relevant to each product, fulfilling post-marketing requirements and commitments. The proposed model can be applied to other pediatric and adult diseases, potentially transforming the paradigm of pharmacosurveillance in response to the growing public mandate for rigorous post-marketing safety monitoring.

Changing the culture of academic medicine to eliminate the gender leadership gap: 50/50 by 2020.

Central to the daily struggles that successful working women face is the misalignment of the current work culture and the values of the workforce. In addition to contributing to work-life integration conflicts, this disconnect perpetuates the gender leadership gap. The dearth of women at the highest ranks of academic medicine not only sends a clear message to women that they must choose between career advancement and their personal life but also represents a loss of talent for academic health centers as they fail to recruit and retain the best and the brightest. To close the gender leadership gap and to meet the needs of the next generation of physicians, scientists, and educators, the authors argue that the culture of academic medicine must change to one in which flexibility and work-life integration are core parts of the definition of success. Faculty must see flexibility policies, such as tenure clock extensions and parental leaves, as career advancing rather than career limiting. To achieve these goals, the authors describe the Stanford University School of Medicine Academic Biomedical Career Customization (ABCC) model. This framework includes individualized career plans, which span a faculty member's career, with options to flex up or down in research, patient care, administration, and teaching, and mentoring discussions, which ensure that faculty take full advantage of the existing policies designed to make career customization possible. The authors argue that with vision, determination, and focus, the academic medicine community can eliminate the gender leadership gap to achieve 50/50 by 2020.

An i2b2-based, generalizable, open source, self-scaling chronic disease registry.

OBJECTIVE: Registries are a well-established mechanism for obtaining high quality, disease-specific data, but are often highly project-specific in their design, implementation, and policies for data use. In contrast to the conventional model of centralized data contribution, warehousing, and control, we design a self-scaling registry technology for collaborative data sharing, based upon the widely adopted Integrating Biology & the Bedside (i2b2) data warehousing framework and the Shared Health Research Information Network (SHRINE) peer-to-peer networking software. MATERIALS AND METHODS: Focusing our design around creation of a scalable solution for collaboration within multi-site disease registries, we leverage the i2b2 and SHRINE open source software to create a modular, ontology-based, federated infrastructure that provides research investigators full ownership and access to their contributed data while supporting permissioned yet robust data sharing. We accomplish these objectives via web services supporting peer-group overlays, group-aware data aggregation, and administrative functions. RESULTS: The 56-site Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry and 3-site Harvard Inflammatory Bowel Diseases Longitudinal Data Repository now utilize i2b2 self-scaling registry technology (i2b2-SSR). This platform, extensible to federation of multiple projects within and between research networks, encompasses >6000 subjects at sites throughout the USA. DISCUSSION: We utilize the i2b2-SSR platform to minimize technical barriers to collaboration while enabling fine-grained control over data sharing. CONCLUSIONS: The implementation of i2b2-SSR for the multi-site, multi-stakeholder CARRA Registry has established a digital infrastructure for community-driven research data sharing in pediatric rheumatology in the USA. We envision i2b2-SSR as a scalable, reusable solution facilitating interdisciplinary research across diseases.

Algorithm development for corticosteroid management in systemic juvenile idiopathic arthritis trial using consensus methodology.

BACKGROUND: The management of background corticosteroid therapy in rheumatology clinical trials poses a major challenge. We describe the consensus methodology used to design an algorithm to standardize changes in corticosteroid dosing during the Randomized Placebo Phase Study of Rilonacept in Systemic Juvenile Idiopathic Arthritis Trial (RAPPORT). METHODS: The 20 RAPPORT site principal investigators (PIs) and 4 topic specialists constituted an expert panel that participated in the consensus process. The panel used a modified Delphi Method consisting of an on-line questionnaire, followed by a one day face-to-face consensus conference. Consensus was defined as ≥ 75% agreement. For items deemed essential but when consensus on critical values was not achieved, simple majority vote drove the final decision. RESULTS: The panel identified criteria for initiating or increasing corticosteroids. These included the presence or development of anemia, myocarditis, pericarditis, pleuritis, peritonitis, and either complete or incomplete macrophage activation syndrome (MAS). The panel also identified criteria for tapering corticosteroids which included absence of fever for ≥ 3 days in the previous week, absence of poor physical functioning, and seven laboratory criteria. A tapering schedule was also defined. CONCLUSION: The expert panel established consensus regarding corticosteroid management and an algorithm for steroid dosing that was well accepted and used by RAPPORT investigators. Developed specifically for the RAPPORT trial, further study of the algorithm is needed before recommendation for more general clinical use.

Decrease in hospital-wide mortality rate after implementation of a commercially sold computerized physician order entry system.

BACKGROUND: Implementations of computerized physician order entry (CPOE) systems have previously been associated with either an increase or no change in hospital-wide mortality rates of inpatients. Despite widespread enthusiasm for CPOE as a tool to help transform quality and patient safety, no published studies to date have associated CPOE implementation with significant reductions in hospital-wide mortality rates. OBJECTIVE: The objective of this study was to determine the effect on the hospital-wide mortality rate after implementation of CPOE at an academic children's hospital. PATIENTS AND METHODS: We performed a cohort study with historical controls at a 303-bed, freestanding, quaternary care academic children's hospital. All nonobstetric inpatients admitted between January 1, 2001, and April 30, 2009, were included. A total of 80,063 patient discharges were evaluated before the intervention (before November 1, 2007), and 17,432 patient discharges were evaluated after the intervention (on or after November 1, 2007). On November 4, 2007, the hospital implemented locally modified functionality within a commercially sold electronic medical record to support CPOE and electronic nursing documentation. RESULTS: After CPOE implementation, the mean monthly adjusted mortality rate decreased by 20% (1.008-0.716 deaths per 100 discharges per month unadjusted [95% confidence interval: 0.8%-40%]; P = .03). With observed versus expected mortality-rate estimates, these data suggest that our CPOE implementation could have resulted in 36 fewer deaths over the 18-month postimplementation time frame. CONCLUSION: Implementation of a locally modified, commercially sold CPOE system was associated with a statistically significant reduction in the hospital-wide mortality rate at a quaternary care academic children's hospital.

Availability of pediatric rheumatology training in United States pediatric residencies.

OBJECTIVE: To characterize the availability of pediatric rheumatology training in general pediatric residencies. METHODS: We surveyed 195 pediatric residency program directors in the US using a combined Web-based and paper-based survey format. The survey asked directors about the availability of an on-site pediatric rheumatologist in their institution, the availability of formal pediatric rheumatology rotations, and the types of physicians involved in teaching curriculum components related to pediatric rheumatology. Survey responses were analyzed using descriptive and bivariate statistics. RESULTS: Of the 195 program directors surveyed, 127 (65%) responded. More than 40% of responding programs did not have a pediatric rheumatologist on site. Programs with on-site pediatric rheumatologists were significantly more likely than those without on-site pediatric rheumatologists to have an on-site pediatric rheumatology rotation available (94% versus 9%; P < 0.001). Although pediatric rheumatologists' involvement in 4 curriculum areas relevant to pediatric rheumatology is nearly universal in programs with on-site pediatric rheumatologists, nearly two-thirds of programs without on-site pediatric rheumatologists rely on internist rheumatologists, general pediatricians, or other physicians to cover these areas. CONCLUSION: Programs without pediatric rheumatologists on site are less likely to have pediatric rheumatology rotations and are more likely to rely on internist rheumatologists and nonrheumatologists to address rheumatology-related curriculum components. Lack of exposure to pediatric rheumatology during residency may impede general pediatricians' ability to identify and treat children with rheumatic diseases, undermine resident interest in this field, and perpetuate low levels of supply.

Role of pediatric and internist rheumatologists in treating children with rheumatic diseases.

OBJECTIVE: To quantify and describe the role of internist and pediatric rheumatologists in the care of children with rheumatic diseases and identify factors associated with internist rheumatologists' willingness to treat children. METHODS: We surveyed physician members of the American College of Rheumatology who currently practice in California (n = 589). Bivariate and logit analyses were used to examine the effects of training, provider, practice, and distance to the nearest pediatric rheumatologist on the likelihood that an internist rheumatologist treated children. RESULTS: Our effective response rate was 51%. More than one third of internist rheumatologists who practice in California reported treating pediatric patients. On average, internist rheumatologists who treated children saw 3.1 patients younger than 18 years weekly; half of these patients were 16 and 17 years of age. In logistic regression analysis, internist rheumatologists who treat pediatric patients were significantly more likely to practice in a multispecialty clinic (adjusted odds ratio: 3.5; 95% confidence interval: 1.9-9.7) and to live >50 miles from a pediatric rheumatologists (adjusted odds ratio: 6.8; 95% confidence interval: 2.1-22.7). In aggregate, we estimate that pediatric rheumatologists and internist rheumatologists provide care to 550 and 419 patients younger than 18 years per week, respectively. CONCLUSIONS: A substantial number of California internist rheumatologists are involved in the care of children, especially adolescents. The heavy involvement of internist rheumatologists in the care of children suggests that additional pediatric rheumatologists may be needed in select areas. Our findings have important implications for the size and distribution of the pediatric rheumatology workforce, the content of fellowship training for internist rheumatologists, and future studies of the relative quality of pediatric rheumatology care offered by internist rheumatologists. Furthermore, the role of internist subspecialists in caring for children with other chronic illness should be assessed.

Access to pediatric rheumatology care in the United States.

OBJECTIVE: To describe rheumatology providers, depict their availability, and determine the extent to which internist rheumatologists may expand access to care for children with rheumatic diseases. METHODS: Using data from the American College of Rheumatology and the Bureau of Health Professions Area Resource File, we generated a national map of providers' practice locations and calculated distances between each county and the nearest rheumatologist. We also performed a logit analysis to identify provider and county characteristics that were associated with internist rheumatologists' willingness to treat children. RESULTS: Approximately 50% of the under 18 population in the United States live within 50 miles of a pediatric rheumatologist and nearly 90% live within 50 miles of a pediatric rheumatologist or an internist rheumatologist who treats children. Internist rheumatologists in private practice were 3 times as likely as those in medical schools to treat children (P < 0.001). Likewise, internist rheumatologists who live 200 or more miles from a pediatric rheumatologist were more than twice as likely to treat children as those who lived within 10 miles of a pediatric rheumatologist (P < 0.001). CONCLUSIONS: Our analysis suggests that internist rheumatologists are more geographically diffuse than pediatric rheumatologists and act as substitutes for pediatric rheumatologists in those regions that lack such providers. Research is needed to understand the role of internist rheumatologists in caring for children with rheumatic diseases and the quality of the care that they provide to this population.

Novel therapies in pediatric rheumatic diseases.

PURPOSE OF REVIEW: Better understanding of the etiology of autoimmune diseases and their progression has brought about numerous novel therapies used in the treatment of pediatric rheumatic diseases. The introduction of biologic agents such as tumor necrosis factor inhibitors has changed how we approach and manage autoimmune diseases. This has led to a proliferation of other therapies targeting specific inflammatory processes evident in many rheumatic illnesses, with hopes of improving efficacy and decreasing adverse effects from treatment. RECENT FINDINGS: Clinical studies demonstrate safety and efficacy of these newer medications in both adults and children. Although most of the novel therapies have been studied primarily in the adult rheumatic population, many are being evaluated in children in randomized controlled and open label trials as well. Long-term results are being collected regarding these newer regimens in both adults and children. SUMMARY: This review looks at the risks and benefits of the variety of novel therapies including the new biologics, immunosuppressives, and stem cell transplantation currently being used in rheumatic conditions. Using these new therapies along with traditional antirheumatic medications, pediatric rheumatologists intervene to control disease early and more effectively to prevent long-term damage and complications.