A prospective, controlled multisite trial of yoga in pediatric inflammatory bowel disease.

AIM: To investigate whether a structured yoga program improves health-related quality of life (HRQOL) and self-efficacy in pediatric patients receiving care for inflammatory bowel disease (IBD). METHODS: IBD patients who were 10-17 years old participated in a 12 week, in-person yoga intervention at two clinical sites. Outcomes were measured at time of consent (T0), start of yoga (T1), and completion of yoga (T2) and 3 months after yoga completion (T3) using the IMPACT-III, Pediatric Quality of Life Inventory (PedsQL), and General Self Efficacy (GSE) scales. RESULTS: Seventy-eight patients were enrolled. Fifty-six patients completed nine or more classes. 73.2% had Crohn's disease and 26.8% ulcerative colitis or IBD-unclassified. A significant increase in IMPACT-III was seen from T1 to T3 (mean change of 5.22, SD = 14.33, p = 0.010), in the PedsQL (mean change = 2.3, SD = 10.24, p = 0.050), and GSE (mean change = 1, SD = 3.60, p = 0.046). 85.2% of patients reported yoga helped them to control stress. Long-term data was available for 47 subjects with 31.9% (n = 15) continuing to practice yoga one to 3 years after study completion. CONCLUSION: This structured 12-week yoga program showed significant improvements in HRQOL and general self-efficacy, particularly 3 months after classes were concluded suggesting that yoga's benefits may persist. Yoga is a safe and effective adjunct to standard medical care to improve QOL and self-efficacy in youth with IBD.

PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls.

OBJECTIVE: The primary objective was to compare the gastrointestinal (GI) symptoms and worry of pediatric patients with functional GI disorders (FGIDs) and organic GI diseases to healthy controls utilizing the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms and Worry Scales for patient self-reports ages 5-18 years and parent proxy-reports for ages 2-18 years. The secondary objective was to compare FGIDs and organic GI diseases to each other. METHODS: The PedsQL™ Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 587 pediatric patients with GI disorders and 685 parents of patients. Patients had physician-diagnosed GI disorders (chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn's disease, ulcerative colitis, and gastroesophageal reflux disease). Ten Gastrointestinal Symptoms Scales measuring Stomach Pain, Stomach Discomfort When Eating, Food and Drink Limits, Trouble Swallowing, Heartburn and Reflux, Nausea and Vomiting, Gas and Bloating, Constipation, Blood, and Diarrhea were administered along with two Gastrointestinal Worry Scales. Five hundred and thirteen healthy children and 337 parents of healthy children completed the PedsQL™ Gastrointestinal Scales in an Internet panel survey. RESULTS: The PedsQL™ Gastrointestinal Symptoms and Worry Scales distinguished between pediatric patients with FGIDs and organic GI diseases in comparison with healthy controls, supporting known-groups validity. Patients with FGIDs reported more GI symptoms and worry than patients with organic GI diseases. CONCLUSIONS: The PedsQL™ Gastrointestinal Symptoms and Worry Scales may be utilized as common metrics across pediatric patient groups with FGIDs and organic GI diseases and healthy samples to measure GI-specific symptoms in clinical research and practice.

PedsQL gastrointestinal symptoms module: feasibility, reliability, and validity.

OBJECTIVE: The objective of this study was to report on the measurement properties of the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module for patients with functional gastrointestinal (GI) disorders (FGIDs) and organic GI diseases, hereafter referred to as "GI disorders," for patient self-report ages between 5 and 18 and parent proxy-report for ages between 2 and 18 years. METHODS: The 74-item PedsQL GI Module and 23-item PedsQL Generic Core Scales were completed in a 9-site study by 584 patients and 682 parents. Patients had physician-diagnosed GI disorders (such as chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn disease, ulcerative colitis, gastroesophageal reflux disease). RESULTS: Fourteen unidimensional scales were derived measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood, diarrhea, worry, medicines, and communication. The PedsQL GI Module Scales evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.97, parent proxy-report α = 0.97), and good-to-excellent reliability for the 14 individual scales (patient self-report α = 0.67-0.94, parent proxy-report α = 0.77-0.95). Intercorrelations with the Generic Core Scales supported construct validity. Individual Symptoms Scales known-groups validity across 7 GI disorders was generally supported. Factor analysis supported the unidimensionality of the individual scales. CONCLUSIONS: The PedsQL GI Module Scales demonstrated acceptable-to-excellent measurement properties and may be used as common metrics to compare GI-specific symptoms in clinical research and practice both within and across patient groups for FGIDs and organic GI diseases.

Parental perceptions of research after completion of placebo-controlled trials in pediatric gastroenterology.

BACKGROUND AND OBJECTIVES: Investigators may have concerns that parents will not allow their children to participate in placebo-controlled trials (PCTs). The aim of the present study was to identify potential differences between parental perceptions in families who successfully completed (CO) a clinical trial compared with those who were noncompleters (NC). PATIENTS AND METHODS: Parents of both CO and NC children enrolled in pediatric gastrointestinal studies performed in the previous year were eligible. NC were defined as those who were screen failures or treatment nonresponders or had adverse events. One hundred seven parents were identified and mailed a 26-item questionnaire eliciting perceptions regarding participation in research. Questionnaires were sent 6 months after participation in research ended. RESULTS: Seventy-eight (69%) parents returned the survey. Characteristics included maternal responders (98%), English as primary language (97%), and education beyond high school (85%). Five parents (4.7%) had children involved in previous research trials. There were no significant differences in responses found between CO (n = 49; 63%) and NC (n = 29; 37%) in regard to importance of research, perceptions of risk to child, benefits to child, and more attention in the study. Statistical significance was approached in regard to the comfort with the research team, with a greater portion of CO stating that the researcher put the parent at ease and the NC feeling less positive about the interaction (P = 0.05). CONCLUSIONS: A positive perception about participation in research is not stratified by successful completion of a PCT. These results should encourage investigators and institutional review boards that if properly designed and conducted, pediatric PCTs can result in a positive experience for parents.

Similar Long-Term Outcomes in Children Presenting With Abscess vs Phlegmon at Diagnosis of Crohn Disease.

Background: Limited data are available for long-term outcomes of pediatric patients with abdominal abscess or phlegmon at diagnosis of Crohn disease. Methods: We performed a retrospective chart review of such children over a recent 6-year period at 5 pediatric inflammatory bowel diseases. Results: Fifty-two patients (mean age 15.9 ± 1.8 years) were reviewed. Thirty-six had an abscess and 27 (75%) required resectional therapy compared to 16 with phlegmon which 10 (63%) requiring surgery. Overall (37/52) 71% had surgery which was performed within 6 months in 32 (86%). Conclusions: A similar high surgical rate exists whether pediatric patients with Crohn disease present with abscess or phlegmon.

Chronic abdominal pain and depressive symptoms: analysis of the national longitudinal study of adolescent health.

BACKGROUND & AIMS: Abdominal pain is common in adolescence. The aim of this study was to determine the prevalence of depressive symptoms in a large cohort of patients with frequent abdominal pain. METHODS: A prospective, cross-sectional, nationally representative sample of children aged 13 to 18 years (mean age, 16.2 +/- 1.7 y; 49% male) completed in-home interviews and separate in-school questionnaires for the National Longitudinal Study in Adolescent Health (the Add Health Study). Depressed mood was assessed with the Center for Epidemiologic Studies Depression Scale. Subjective measures of abdominal pain were reported by 20,745 adolescents from wave 1 of the Add Health Study. Frequency of abdominal pain over the previous 1 year was rated as rare (0-1 episode/wk), moderate (2-3 episodes/wk), or daily (>or=4 episodes/wk). RESULTS: Daily pain is reported in 3.2% of adolescents, with an additional 14% reporting pain as moderate in frequency. Sixteen percent of all adolescents are at risk for developing depression. The risk for depression goes from 16% to 45% (P < .001) when the pain is daily. Compared with rare pain, children with daily pain were more likely to miss school 10 or more times per year (46% vs 19%, P < .001), cry (12.1% vs 1%, P < .001), feel sad (25.2% vs 5.3%, P < .001), and lonely (25.2% vs 6.4%, P < .001). Children with daily pain were likely to consider life a failure versus those with no pain (10.2% vs 3.3%, P < .001). CONCLUSIONS: Adolescents with frequent abdominal pain are at increased risk for depressive symptoms, social isolation, and missing school.

PEG3350 in the treatment of childhood constipation: a multicenter, double-blinded, placebo-controlled trial.

OBJECTIVE: To establish the efficacy and best starting dose of polyethylene glycol (PEG)3350 in the short-term treatment of children with functional constipation. STUDY DESIGN: Prospective, randomized, multicenter, double-blinded, placebo-controlled, dose-ranging study of PEG3350 in children with functional constipation. Patients were randomly assigned to either placebo or 0.2 g/kg per day, 0.4 g/kg per day, or 0.8 g/kg per day of PEG3350 after a 1 week run-in period, followed by 2 weeks of treatment. All received behavior modification. The primary outcome was the proportion of patients with a successful treatment response: >or=3 bowel movements (BM) in the second week. RESULTS: 103 children (mean, 8.5 +/- 3.1 years) were enrolled. 77%, 74%, and 73% of the 0.2, 0.4, and 0.8 g/kg groups were successfully treated, as compared with 42% receiving placebo (P < .04). There was a significant increase in BM (P < .001) and straining improvement (P < .05) with the different PEG3350 doses. Stool consistency improved significantly for doses 0.4 g/kg or higher (P < .001). There was more abdominal pain and fecal incontinence in patients receiving 0.8 g/kg. PEG3350 was well tolerated. CONCLUSIONS: This placebo-controlled study confirms the efficacy and safety of PEG3350 for the short-term treatment of children with functional constipation. We recommend a starting dose of 0.4 g/kg per day.

Quality of life for children with functional abdominal pain: a comparison study of patients' and parents' perceptions.

OBJECTIVE: Children with chronic abdominal pain of nonorganic origin, termed functional abdominal pain (FAP), experience school absences and social withdrawal and report impaired physical ability. The aim of this study was to assess patients' and parents' perceptions of health-related quality of life (QoL) for children with FAP. METHODS: Between October 2002 and November 2003, 209 children (including 125 girls; age: 11.2 +/- 3.5 years) and 209 parents were recruited from a pediatric referral center. At the time of their initial evaluations, participants completed a validated, health-related QoL instrument (Pediatric Quality of Life Inventory), which was scored on a scale of 0 (poor) through 100 (best). Children with FAP (n = 65) and their families were compared with control groups of healthy children (n = 46) and children with histologically proven inflammatory bowel disease (IBD) (n = 42) or gastroesophageal reflux disease (GERD) (n = 56). RESULTS: Children with FAP had self-reported QoL scores (score: 78) that were similar to those for children with GERD (score: 80) or IBD (score: 84). Children with FAP had lower QoL scores than did healthy children (score: 88). Parents of children with FAP reported lower QoL scores, compared with their children's scores (scores: 70 vs 78). CONCLUSIONS: Children with FAP reported lower QoL, compared with their healthy peers, and had the same QoL scores as did children with IBD or GERD. Parents' perceptions of QoL for children with FAP were lower than their children's self-reported scores. These findings highlight the clinical significance of FAP and may provide insight into one facet of the disease's biopsychosocial etiology.

Chronic childhood constipation is associated with impaired quality of life: a case-controlled study.

OBJECTIVE: The objective of this study was to investigate the effect of chronic constipation on children's quality of life. METHODS: From October 2002 to November 2003, 224 children (140 male, 84 female, aged 10.6 +/- 2.9 years) and 224 parents were evaluated by a health related quality of life tool during initial outpatient consultation. Children with constipation (n = 80) were compared with controls with inflammatory bowel disease (n = 42), controls with gastroesophageal reflux disease (n = 56), and with healthy children (n = 46). RESULTS: Children with constipation had lower quality of life scores than did those with inflammatory bowel disease (70 versus 84; P < 0.05), gastroesophageal reflux disease (70 versus 80; P < 0.05), and healthy children (70 versus 88; P < 0.05). Children with constipation reported lower physical scores than did inflammatory bowel disease patients (75 versus 85; P < 0.02), gastroesophageal reflux disease patients (75 versus 85; P < 0.05), or healthy children (75 versus 87; P < 0.05). Parents of children with constipation reported lower scores than did their children (61 versus 70; P < 0.05). Children with constipation had longer duration of symptoms than did the controls with inflammatory bowel disease and gastroesophageal reflux disease (43.8 months versus 14.2 months; P < 0.001). Prolonged duration of symptoms for children with constipation correlated with lower parent-reported scores (P < 0.002). CONCLUSIONS: At initial evaluation, children with constipation have a lower quality of life than do children with inflammatory bowel disease or gastroesophageal reflux disease. Self-reported lower scores may be a reflection of impaired physical ability. Parental perceptions of low quality of life are probably impacted by the duration of their child's symptoms and by family members with similar complaints. Practitioners should be aware of the high level of parental concern and the relatively low self-reported and parent-reported quality of life in children with chronic constipation as they plan therapy.