Development and testing of a CD-ROM program for improving adolescent knowledge of inflammatory bowel disease.

OBJECTIVE: The aim of this study was to design a theory-based educational program for adolescents with inflammatory bowel disease (IBD) using an interactive multimedia CD-ROM and to test its effectiveness in improving knowledge in IBD. MATERIALS AND METHODS: Curriculum-based instruction using educational theory and principles was designed for adolescents on an interactive multimedia CD-ROM. Twenty subjects completed summative evaluation of the CD-ROM measuring gain in knowledge about IBD immediately and 9 months after instruction. RESULTS: Subjects found the CD-ROM to be informative, appealing, and easy to use. The mean baseline score of the adolescents on the Crohn's and Colitis Knowledge questionnaire was 12.2 (standard deviation 5.14, range 3-24). After an average of 30 minutes of self-directed learning, adolescent subjects increased their posttest score to a mean of 19.8, a gain of 7.6 points over baseline (95% confidence interval 5.2-10.1, P < 0.0001). Knowledge of medications, disease complications, and gastrointestinal structure and function was gained and retained upon retesting at 9 months with a mean Crohn's and Colitis Knowledge questionnaire score of 17.5 (standard deviation 3.9, range 12-26), which was still an improvement over the mean pretest knowledge score of 12.2 (P < 0.001). CONCLUSIONS: Adolescents with IBD have low baseline knowledge about their disease. A rigorously developed interactive educational tool is now available for instructing adolescent patients about their IBD.

A randomized controlled trial of growth hormone in active pediatric Crohn disease.

OBJECTIVES: Growth hormone (GH) may reduce symptoms and improve growth in Crohn disease (CD). The effect on mucosal inflammation is not known. We hypothesized that GH would improve both clinical and mucosal disease activity and stimulate linear growth in pediatric CD. PATIENTS AND METHODS: Twenty patients ages 7 to 18 receiving corticosteroids (CTX) for active CD were randomized to begin GH, 0.075 mg x kg(-1) x day(-1) (group A), or continue CTX alone (group B). Clinical and endoscopic disease activities were assessed after 12 weeks. Group B began GH at 12 weeks, and clinical disease activity was assessed at 24 weeks. Subjects who experienced a clinical response after 12 weeks of GH therapy continued treatment for an additional 52 weeks, and linear growth was assessed. RESULTS: Sixty-five percent of patients receiving GH achieved clinical remission, compared with 20% treated with CTX alone (P = 0.03). Although endoscopic disease activity trended toward an improvement at week 12 in group A, this did not differ between the groups. Sixty-one percent of week 12 GH responders maintained their clinical response through week 64. Mean (95th confidence interval) height z score on GH increased from -1.1 (-1.6, -0.6) to -0.4 (-1, 0.2), P = 0.004 during this 52-week extension phase. GH was well tolerated with no unexpected safety signals. CONCLUSIONS: The addition of GH to CTX therapy did not induce a reduction in mucosal inflammation, relative to CTX alone. However, GH was safe and effective as an adjunct to CTX for treatment of clinical disease activity and growth failure in pediatric CD.

Growth abnormalities persist in newly diagnosed children with crohn disease despite current treatment paradigms.

OBJECTIVES: We analyzed growth outcomes in children newly diagnosed with Crohn disease and determined whether growth abnormalities persist despite current therapies. PATIENTS AND METHODS: Clinical and growth data were prospectively obtained on an inception cohort younger than 16 years old at diagnosis and Tanner I to III during the study. RESULTS: In all, 176 children (mean age 10.1 years; 65% male) with mild (33%) or moderate/severe (67%) disease at diagnosis were studied. Disease activity at 1 year was inactive/mild (89%) or moderate/severe (11%). First-year treatments included immunomodulators (60%), corticosteroids (77%), 5-aminosalicylates (61%), infliximab (15%), and enteral nutrition (10%). By 2 years, 86% had received immunomodulators and 36% infliximab. Mean height z scores at diagnosis, 1 year, and 2 years were -0.49 +/- 1.2 standard deviations (SDs), -0.50 +/- 1.2, and -0.46 +/- 1.1, respectively. Of the subjects, 10%, 8%, and 6.5% had height z scores less than -2 SD at diagnosis, 1 year, and 2 years. A height velocity z score less than -1SD was seen in 45% of subjects at 1 year and 38% at 2 years. The mean height velocity z score, however, increased between 1 and 2 years from -0.71 to 0.26 (P < 0.03). Corticosteroid use greater than 6 months in the first year was associated with abnormal height velocity at 1 year (adjusted odds ratio = 4.5; 95% confidence interval [CI] = 2.2-9.6). No statistically significant effect on height velocity z scores was noted when comparing those receiving or not receiving infliximab. CONCLUSIONS: Growth delay persists in many children with CD following diagnosis, despite improved disease activity and the frequent use of immunomodulators and biologics. Additional strategies to improve growth outcomes require development.

Course and treatment of perianal disease in children newly diagnosed with Crohn's disease.

BACKGROUND: We sought to characterize perianal disease and its treatment in pediatric patients newly diagnosed with Crohn's disease. METHODS: Data were obtained from the Pediatric Inflammatory Bowel Disease (IBD) Collaborative Group Registry, a prospective, multicenter observational registry recording clinical and laboratory outcomes in children under 16 years of age newly diagnosed with IBD. Patients with Crohn's disease were selected who had data on perianal disease and at least 24 months of follow-up. The records of patients with a Pediatric Crohn's Disease Activity Index perianal subscore greater than 0 were reviewed, and patients with abscesses or fistulas were selected. The therapies used and the course of their perianal disease were then assessed. RESULTS: Of the 276 patients identified, 41 had perianal lesions within 30 days of diagnosis. Thirteen of these had skin tags and fissures only, whereas 28 had fistulas and/or abscesses. The latter lesions resolved by 1 year in 20 patients, and 8 had chronic/recurrent perianal disease persisting for more than 1 year following diagnosis. Patients with fistulizing disease were much more likely to be treated and were treated earlier with antibiotics, infliximab, and immunomodulators than were nonfistulizing patients. Patients who developed chronic perianal disease were more likely to have low body mass indices and required more perianal surgery than did patients whose perianal disease resolved. CONCLUSIONS: Approximately 10% of newly diagnosed pediatric patients with Crohn's disease will have perianal fistulas and/or abscesses at the time of diagnosis. Most of these will resolve within a year with medical therapy alone.

Health values in adolescents with or without inflammatory bowel disease.

OBJECTIVE: To examine for differences in and predictors of health value/utility scores in adolescents with or without inflammatory bowel disease (IBD). STUDY DESIGN: Adolescents with IBD and healthy control subjects were interviewed in an academic health center. We collected sociodemographic data and measured health status, personal, family, and social characteristics, and spiritual well-being. We assessed time tradeoff (TTO) and standard gamble (SG) utility scores for current health. We performed bivariate and multivariable analyses with utility scores used as outcomes. RESULTS: Sixty-seven patients with IBD and 88 healthy control subjects 11 to 19 years of age participated. Among subjects with IBD, mean (SD) TTO scores were 0.92 (0.17), and mean (SD) SG scores were 0.97 (0.07). Among healthy control subjects, mean (SD) TTO scores were 0.99 (0.03) and mean (SD) SG scores were 0.98 (0.03). TTO scores were significantly lower (P= .001), and SG scores trended lower (P= .065) in patients with IBD when compared with healthy control subjects. In multivariable analyses controlling for IBD status, poorer emotional functioning and spiritual well-being were associated with lower TTO (R(2)=0.17) and lower SG (R(2)=0.22) scores. CONCLUSION: Direct utility assessment in adolescents with or without IBD is feasible and may be used to assess outcomes. Adolescents with IBD value their health state highly, although less so than healthy control subjects. Emotional functioning and spiritual well-being appear to influence utility scores most strongly.

Effect of early immunomodulator use in moderate to severe pediatric Crohn disease.

BACKGROUND: The immunomodulators (IMs) 6-mercaptopurine and azathioprine decrease corticosteroid dependence and maintain remission in Crohn's disease (CD). We describe IM use in newly diagnosed pediatric CD, comparing outcomes of "early" versus "late" initiation of therapy. METHODS: Data were obtained from pediatric CD patients enrolled in a prospective, multicenter observational study. Moderate/severe disease patients treated with IM were compared for outcomes of remission, corticosteroid use, infliximab therapy, hospitalizations, and CD-related surgery based on timing of initiation of IM therapy. RESULTS: In all, 247 children met the criteria (60% male, mean age 11.9 years); 199 were treated with IM within 1 year of diagnosis; 150 between 0-3 months (early), 49 between 3-12 months (late). Both groups showed a decrease in corticosteroid use by 12 months, at which time proportionately fewer early group patients had received corticosteroids in the preceding quarter (22%) than late groups patients (41%)(P = 0.013). The number of hospitalizations per patient was also noted to be significantly lower in the early group over the 2-year follow-up (P = 0.03). No difference was noted in the rates of remission, infliximab use over time, or surgery. CONCLUSIONS: 80% of children with newly diagnosed moderate to severe CD are treated with IM within 1 year. Early IM use is associated with reduced corticosteroid exposure and possibly fewer hospitalizations per patient.

Corticosteroid therapy in the age of infliximab: acute and 1-year outcomes in newly diagnosed children with Crohn's disease.

BACKGROUND & AIMS: The aim of this study was to describe 3-month and 1-year outcomes of children with Crohn's disease (CD) treated with corticosteroids within 30 days of diagnosis, with particular emphasis on the influence of infliximab on these outcomes. We also aimed to determine whether there are clinical or laboratory characteristics associated with corticosteroid therapy outcomes. METHODS: Data from 109 children were drawn from a multicenter observational registry that was started in 2002. Clinical characteristics and data on corticosteroid and other therapies were recorded prospectively. Corticosteroid therapy outcomes at 3 months were defined as complete acute response, partial response, or corticosteroid resistance. At 1 year, corticosteroid responsiveness, dependence, and surgical rates were determined. Infliximab's influence on short- and long-term outcomes also was investigated. RESULTS: At 3 months, 65 of 109 (60%) patients had a complete acute response to corticosteroids, 26 (24%) had a partial response, and 18 (17%) were corticosteroid resistant. At 1 year, 61% were corticosteroid responsive, 31% were corticosteroid dependent, and 8% required surgery. Irrespective of the duration of corticosteroid treatment, 16 of 24 of corticosteroid-dependent/resistant patients rapidly discontinued corticosteroids after starting infliximab. No clinical or laboratory characteristics at diagnosis predicted short-term outcome. Growth impairment at diagnosis increased risk for corticosteroid dependence or surgery at 1 year. CONCLUSIONS: At 3 months, 84% of children had a complete or partial response to corticosteroids. However, despite concomitant immunomodulators, at 1 year 31% were corticosteroid dependent and 8% required surgery. Infliximab improves outcomes of corticosteroid-dependent/resistant patients because the duration of corticosteroid use can be controlled by initiating treatment with infliximab.

The natural history of corticosteroid therapy for ulcerative colitis in children.

BACKGROUND & AIMS: The aim of this study was to determine the clinical outcome after corticosteroid therapy in children who are newly diagnosed with ulcerative colitis (UC). METHODS: Data were gathered prospectively from the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry database between January 2002 and March 2005. All children who were newly diagnosed with inflammatory bowel disease younger than the age of 16 years were managed according to the dictates of their respective physicians. Demographic, clinical, and laboratory data were collected at diagnosis, at 30 days, and then quarterly. Patients were classified as corticosteroid responsive, corticosteroid dependent, or refractory, and outcomes were determined at 3 months and at 1 year. RESULTS: Ninety-seven patients had a diagnosis of UC and a minimum of 1 year of follow-up evaluation; 77 (79%) received corticosteroids (62 within 30 days of diagnosis [early] and 15 between 31 days and 6 months [late]). At diagnosis, 81% of corticosteroid-treated patients (age, 11.3 +/- 3.5 y) had moderate/severe disease, and 81% had pancolitis. For those treated early with corticosteroids, disease activity at 3 months was inactive in 60%, mild in 27%, and moderate/severe in 11%. At 1 year, 31 of 62 (50%) of the early corticosteroid-treated patients were considered corticosteroid responsive and 28 (45%) were corticosteroid dependent. A total of 4 patients receiving corticosteroids (5%) required colectomy in the first year. Immunomodulators were used in 61% of all corticosteroid-treated patients. CONCLUSIONS: Although short-term clinical response to corticosteroids in children with newly diagnosed UC is excellent, even with the common use of immunomodulators corticosteroid dependence is seen in 45% of patients.

Variability in the management of childhood constipation.

To assist primary care providers, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) published clinical practice guidelines for management of childhood constipation. A cross-sectional survey of pediatricians from across the United States was conducted to assess pediatricians' constipation management strategies, whether pediatricians are familiar with the NASPGHAN constipation guidelines, and reasons pediatricians refer constipated patients to a pediatric gastroenterologist. Overall, 75% of pediatricians used polyethylene glycol without electrolytes to treat childhood constipation, 8% of pediatricians were aware NASPGHAN had published constipation guidelines, and parental pressure was just one reason pediatricians referred constipated patients to a pediatric gastroenterologist.