Brendan Boyle

ImproveCareNow: The development of a pediatric inflammatory bowel disease improvement network

&NA; There is significant variation in diagnostic testing and treatment for inflammatory bowel disease. Quality improvement science methods can help address unwarranted variations in care and outcomes. Methods: The ImproveCareNow Network was established under the sponsorship of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the American Board of Pediatrics as a prototype for a model of improving subspecialty care that included three components: 1) creating enduring multicenter collaborative networks of pediatric subspecialists, 2) sharing of performance data collected in patient registries, and 3) training in quality improvement. The network began with a focus on improving initial diagnostic testing and evaluation, the classification of the severity and extent of disease, the detection and treatment of inadequate nutrition and growth, and the appropriate dosing of immunomodulator medications. Changes are based on an evidence‐based model of chronic illness care involving the use of patient registries for population management, previsit planning, decision support, promoting self‐management, and auditing of care processes. Results: Currently, patients are being enrolled at 23 sites. Through 2009, data have been analyzed on over 2500 patients from over 7500 visits. Initial results suggest improvements in both care processes (e.g., appropriate medication dosing and completion of a classification bundle that includes the patients diagnosis, disease activity, distribution and phenotype, growth status, and nutrition status) and outcomes (e.g., the percentage of patients in remission). Conclusions: These improvements suggest that practice sites are learning how to apply quality improvement methods to improve the care of patients. (Inflamm Bowel Dis 2011;)

Improved Outcomes in a Quality Improvement Collaborative for Pediatric Inflammatory Bowel Disease

OBJECTIVES: Unintended variation in the care of patients with Crohn disease (CD) and ulcerative colitis (UC) may prevent achievement of optimal outcomes. We sought to improve chronic care delivery and outcomes for children with inflammatory bowel disease by using network-based quality improvement methods. METHODS: By using a modified Breakthrough Series collaborative structure, 6 ImproveCareNow Network care centers tested changes in chronic illness care and collected data monthly. We used an interrupted time series design to evaluate the impact of these changes. RESULTS: Data were available for 843 children with CD and 345 with UC. Changes in care delivery were associated with an increase in the proportion of visits with complete disease classification, measurement of thiopurine methyltransferase (TPMT) before initiation of thiopurines, and patients receiving an initial thiopurine dose appropriate to their TPMT status. These were significant in both populations for all process variables (P < .01) except for measurement of TPMT in CD patients (P = .12). There were significant increases in the proportion of CD (55%–68%) and UC (61%–72%) patients with inactive disease. There was also a significant increase in the proportion of CD patients not taking prednisone (86%–90%). Participating centers varied in the success of achieving these changes. CONCLUSIONS: Improvements in the outcomes of patients with CD and UC were associated with improvements in the process of chronic illness care. Variation in the success of implementing changes suggests the importance of overcoming organizational factors related to quality improvement success.

Quality of care in inflammatory bowel disease: A review and discussion

Abstract: The Institute of Medicines publications To Err Is Human and Crossing the Quality Chasm publicized the widespread deficits in U.S. health care quality. Emerging studies continue to reveal deficits in the quality of adult and pediatric care, including subspecialty care. The inflammatory bowel diseases (IBD) Crohns disease and ulcerative colitis require diligent, long‐term management and attention to their impact on intestinal and extraintestinal organ systems. Although the quality of IBD care has not been prospectively or comprehensively evaluated in the United States, several small studies have demonstrated significant variation in care. As variation may indicate underuse, overuse, or misuse of medical services, such variation suggests a clear need for translating evidence‐based practices into the actual practice and follow‐up provided for patients. This article reviews the history, rationale, and methods of quality measurement and improvement and identifies the unique challenges in adapting these general strategies to the care of the inflammatory bowel diseases. Inflamm Bowel Dis 2010

Concomitant Use of Immunomodulators Affects the Durability of Infliximab Therapy in Children With Crohn's Disease

BACKGROUND & AIMS It is important to determine the effects of immunomodulators on the ability of children to remain on infliximab therapy for Crohns disease (durability of therapy), given the potential benefits and risks of concomitant therapy-especially with thiopurines in male patients. We investigated how immunomodulatory treatment affects the durability of infliximab therapy. METHODS We collected data from the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry, from January 2002 through August 2014, on 502 children with Crohns disease who participated in a prospective multicenter study. Data were collected from patients who received at least a 3-dose induction regimen of infliximab, and their concomitant use of immunomodulators: no thiopurine or methotrexate treatment, treatment for 6 months or less during infliximab therapy, or treatment for more than 6 months during infliximab therapy. RESULTS The probabilities (± standard error) that children remained on infliximab therapy for 1 year, 3 years, and 5 years after the treatment began were 0.84 ± 0.02, 0.69 ± 0.03, and 0.60 ± 0.03, respectively. Age, sex, and disease extent or location did not affect the durability of infliximab therapy. Greater length of concomitant use of immunomodulators was associated with increased time of infliximab therapy. The probability that patients with more than 6 months of immunomodulator use remained on infliximab therapy for 5 years was 0.70 ± 0.04, compared with 0.48 ± 0.08 for patients who did not receive immunomodulators and 0.55 ± 0.06 for patients who received immunomodulators for 6 months or less (P < .001). In boys who received immunomodulators for 6 months or more after starting infliximab, the overall durability of infliximab therapy was greater among patients receiving methotrexate than thiopurine (P < .01); the probabilities that they remained on infliximab therapy for 5 years were 0.97 ± 0.03 vs 0.58 ± 0.08, respectively. CONCLUSIONS In children with Crohns disease, concomitant treatment with an immunomodulator for more than 6 months after starting infliximab therapy increases the chances that patients will remain on infliximab. In boys, methotrexate appears to increase the durability of infliximab therapy compared with thiopurine.

Development of process and outcome measures for improvement: Lessons learned in a quality improvement collaborative for pediatric inflammatory bowel disease

The Institute of Medicines publications, To Err is Human and Crossing the Quality Chasm, publicized the widespread deficits in healthcare quality. The quality of care in inflammatory bowel disease (IBD) has not been comprehensively evaluated, in part due to a lack of well-established IBD measures of quality. Quality can be measured for evaluation, benchmarking, or continuous quality improvement, using structural, process, and outcome measures. Measurement is an essential component of the model for improvement, necessary to determine whether changes made have resulted in improvement. Measures used for quality improvement should be based on evidence and consensus, be clear and collectable in a timely fashion, occur with sufficient frequency, and have the potential to improve outcomes. While no current IBD measures of quality are perfect, an iterative process of measure development can produce a set of measures that are feasible, relevant, and useful for performing quality improvement. This review describes the history, rationale, and methods of quality measurement and discusses the early work and lessons learned from measuring quality of care in a pediatric IBD quality improvement collaborative.

A single-center experience with methotrexate after thiopurine therapy in pediatric Crohn disease.

Background and Aim: Thiopurines are a common, effective means of maintaining remission in pediatric Crohn disease (CD). Methotrexate (MTX) may be considered for those intolerant of or unresponsive to thiopurines. The purpose of this study was to examine the effectiveness of MTX as maintenance therapy in patients previously treated with thiopurines. Patients and Methods: All of the patients at Nationwide Childrens Hospital from 1998 to 2007 with an International Classification of Diseases code indicative of CD were identified. Patients with a diagnosis of CD, a history of prior thiopurine use, no current infliximab therapy, and at least 6 months of follow-up after MTX initiation were included. The primary outcome was defined as steroid-/infliximab-free remission determined by the physician global assessment at 6 and 12 months. Secondary outcomes included subsequent treatment with infliximab and/or corticosteroids, rate of discontinuation of MTX, and adverse events (AEs). Results: Twenty-seven patients (17 boys, 63%) with a mean age at diagnosis of 12.3 ± 0.7 years and mean disease duration of 1.49 ± 0.3 years were identified. Indications for MTX included nonresponse to thiopurines, AE, and poor adherence to thiopurines. At 6 and 12 months, 13 of 27 patients (48.1%) and 9 of 27 patients (33.3%), respectively, were in steroid-/infliximab-free remission. A total of 10 patients (37.0%) required infliximab therapy during the 12-month period and 5 patients discontinued MTX. Nausea was the most commonly reported AE. Transient transaminase elevation occurred in 4 patients and transient leukopenia in 2 patients. Conclusions: MTX can be effective as maintenance therapy for patients with pediatric CD previously intolerant of or unresponsive to thiopurines; however, greater than one third of this cohort required escalation to antitumor necrosis factor therapy within 12 months following MTX initiation. MTX was well tolerated.

Role of sex in the treatment and clinical outcomes of pediatric patients with inflammatory bowel disease.

Objective: To examine sex differences in medical therapy and clinical outcomes in pediatric patients with inflammatory bowel disease (IBD). Methods: We performed a cross-sectional analysis of children with Crohn disease (CD) and ulcerative colitis (UC) using data from the ImproveCareNow Network collected between May 2007 and May 2010. Clinical remission, disease severity, body mass index (BMI) z scores, normal height velocity, and medication use were analyzed by sex and age. Results: One thousand four hundred nine patients were included (993 had CD and 416 had UC). No significant sex differences were found in disease severity, BMI, height velocity, or use of medications. Further analysis of combination therapy with infliximab + 6-mercaptopurine/azathioprine and infliximab + methotrexate also did not reveal any differences. No sex differences were found after mediation use was stratified by age (those younger than 13 years and those 13 years old or older). Conclusions: In this sample of CD and UC pediatric patients, no significant sex differences were found in disease severity, BMI, height velocity, or medication use. Our data do not support the use of sex as a major factor in patient risk stratification for children with IBD. In addition, despite concerns for sex-specific complications of some medications, our analysis did not suggest any sex differences in medication use.

The Prevalence and Impact of Functional Abdominal Pain Disorders in Children with Inflammatory Bowel Diseases (IBD-FAPD).

Objectives: We sought to describe the prevalence of the overlap of functional abdominal pain disorders (FAPDs) in children with inflammatory bowel diseases (IBDs), a condition we have designated as IBD-FAPD. We also aimed to describe the psychological profile of this group, and to assess predictors of disease and the impact of IBD-FAPD on quality of life. Methods: This cross-sectional prospective study included patients ages 8 to 18 years with a diagnosis of IBD. Disease activity was assessed by physicians global assessment, laboratory studies, and abbreviated Pediatric Crohns Disease Activity Index or Pediatric Ulcerative Colitis Activity Index scoring. Age-appropriate validated questionnaires were used to diagnose FAPDs according to the Rome III criteria, depression, anxiety symptoms, and quality of life. Results: There were 128 patients recruited. Eighty-one (63%) completed questionnaires (36 girls; 45 boys; mean age 14.4 ± 2.6 years) (62 Crohn disease, 19 ulcerative colitis). The prevalence of IBD-FAPD in clinical remission was 26% (17 Crohn disease, 4 ulcerative colitis; 95% confidence interval: 20.6%–79.4%), with significantly more girls having IBD-FAPD (P = 0.038). Anxiety symptoms were in 14.3% of patients with IBD-FAPD (P = 0.06) and depression in 23.8% (P = 0.006). The average Pediatric Quality of Life Inventory Gastrointestinal Symptoms score for the IBD-FAPD group was significantly lower than those without FAPDs (71 vs 86.5, P = 0.008). Conclusions: In our cohort, the prevalence of IBD-FAPD was 26%. This is the first study to assess all FAPDs using the Rome III criteria and to demonstrate increased anxiety, depression, and worse quality of life in children with IBD-FAPD. The identification of patients predisposed to IBD-FAPD may allow implementing strategies that could improve symptoms and quality of life.

Complementary and Alternative Medicine Use in Children with Inflammatory Bowel Diseases: A Single Center Survey.

Objectives: The prevalence of inflammatory bowel diseases (IBD) and use of complementary and alternative medicine (CAM) are both common and increasing. The definition of CAM therapy among both practitioners and patients is variable. The aim of our study was to update our understanding of how pediatric IBD patients use, perceive, and define CAM therapies. Methods: We surveyed families of patients with IBD followed in the Gastroenterology Division at Nationwide Childrens Hospital in summer 2014 during a routine clinic visit. The survey included questions about the following demographic and disease information; use and side effects associated with prior conventional therapies (CT); and attitudes toward, and use of CAM. Results: The questionnaire was completed by 104 of 118 patients approached (14 ± 3 years; 43% women). Patients had previously used an average of 3 CT. CAM therapy was used by 84% of patients surveyed, although only 24% of patients/families considered themselves to be using CAM. Common CAM therapies included vitamins/supplements, stress management techniques, and/or dietary changes. Factors associated with using specific CAM therapies included self-reported prior CT-related side effects (P < 0.01) and moderate/severe disease activity (P < 0.01). Most families (77%) desired to learn more about CAM. Conclusions: Patients seen in a tertiary care center for pediatric IBD frequently integrated CAM therapies into their treatment regimen. Patients with prior side effects from CT or more severe disease were more likely to use CAM. Given the high prevalence of CAM use, pediatric gastrointestinal physicians should be knowledgeable and open to discussions about CAM therapies with their patients.

Quality of health care in the United States: implications for pediatric inflammatory bowel disease.

The Institute of Medicines publications To Error is Human and Crossing the Quality Chasm publicized the widespread deficits in US health care quality. Emerging studies continue to reveal deficits in the quality of adult and pediatric care, including subspecialty care. In recent years, key stakeholders in the health care system including providers, purchasers, and the public have been applying various quality improvement methods to address these concerns. Lessons learned from these efforts in other pediatric conditions, including asthma, cystic fibrosis, neonatal intensive care, and liver transplantation may be applicable to the care of children with inflammatory bowel disease (IBD).This review is intended to be a primer on the quality of care movement in the United States, with a focus on pediatric IBD. In this article, we review the history, rationale, and methods of quality measurement and improvement, and we discuss the unique challenges in adapting these general strategies to pediatric IBD care.