Prospective Study of Gastrointestinal Symptoms in School Children of South America.

OBJECTIVES: The aim of the study was to establish the prevalence of abdominal pain (AP) in school children in Pasto (Colombia) and determine the effect of AP on their daily activities; and compare the prevalence of AP and other gastrointestinal symptoms between school children from Pasto and Chicago. METHODS: Fourth- and fifth-grade students from a public school and a private school in Colombia were invited to participate in a prospective study using the same methods and questionnaires (Spanish version) as a previous study conducted in Chicago schools. Children completed weekly confidential surveys for 8 consecutive weeks. RESULTS: A total of 332 children participated in the study (40% girls, mean age 9.97 years, median 10, range 8-12 years): public school (288), private school (44). A total of 2425 surveys were analyzed. Out of 2656 possible weekly surveys (332 children × 8 weeks), 91.3% were completed. Overall weekly prevalence of gastrointestinal symptoms: AP (39%), nausea (29.5%), constipation (14%), diarrhea (10.5%), vomiting (9%). Children with AP reported interference with activities: gym (21.9%), school (17.3%), difficulty sleeping (13.7%), and social activities (12.6%). Out of all children, 8.4% sought medical attention for AP during the study period. CONCLUSIONS: Gastrointestinal symptoms are common in school-aged children in Colombia and interfere with both daily activities and school attendance. The prevalence of AP, diarrhea, and vomiting found in the present study was similar to published prevalence of American children using similar methods.

The costs of functional gastrointestinal disorders and related signs and symptoms in infants: a systematic literature review and cost calculation for England.

OBJECTIVES: To estimate the cost of functional gastrointestinal disorders (FGIDs) and related signs and symptoms in infants to the third party payer and to parents. STUDY DESIGN: To estimate the cost of illness (COI) of infant FGIDs, a two-stage process was applied: a systematic literature review and a COI calculation. As no pertinent papers were found in the systematic literature review, a 'de novo' analysis was performed. For the latter, the potential costs for the third party payer (the National Health Service (NHS) in England) and for parents/carers for the treatment of FGIDs in infants were calculated, by using publicly available data. In constructing the calculation, estimates and assumptions (where necessary) were chosen to provide a lower bound (minimum) of the potential overall cost. In doing so, the interpretation of the calculation is that the true COI can be no lower than that estimated. RESULTS: Our calculation estimated that the total costs of treating FGIDs in infants in England were at least £72.3 million per year in 2014/2015 of which £49.1 million was NHS expenditure on prescriptions, community care and hospital treatment. Parents incurred £23.2 million in costs through purchase of over the counter remedies. CONCLUSIONS: The total cost presented here is likely to be a significant underestimate as only lower bound estimates were used where applicable, and for example, costs of alternative therapies, inpatient treatments or diagnostic tests, and time off work by parents could not be adequately estimated and were omitted from the calculation. The number and kind of prescribed products and products sold over the counter to treat FGIDs suggest that there are gaps between treatment guidelines, which emphasise parental reassurance and nutritional advice, and their implementation.

Development of the Brussels Infant and Toddler Stool Scale ('BITSS'): protocol of the study.

INTRODUCTION: The Bristol Stool Form Scale (BSS) which consists of 7 photographs of different stool forms allows assessment of stool consistency (scale 1 for hard lumps to scale 7 for watery stools), in an objective manner in adults. The BSS is also sometimes used to characterise the stools of infants and young children. Despite its use, there is general agreement among paediatric gastroenterologists that the BSS is not adequate to be used in infants and young children who wear diapers; thus, a new scale specifically designed for this population is needed. Our aim is to develop a paediatric stool scale, the Brussels Infant and Toddler Stool Scale ('BITSS'), and to evaluate the interobserver agreement of stool assessment with the BITSS between the patient's parent and healthcare providers (physicians and nurses). METHODS AND ANALYSIS: This study has two phases. In the first phase, 11 key-opinion leaders in the field of paediatric gastroenterology representing different areas of the world selected seven coloured photographs of infants and/or young children wearing diapers to match the original descriptors of the BSS. The selected photographs were used to create a new scale in which the drawings of stools of the BSS were replaced by infant/toddlers stool photographs. In phase II, we aim at demonstrating that parents, nurses and primary healthcare physicians interpret the stool-pictures of the BITSS with a high degree of consensus and that the agreement is independent of whether it is a parent or a healthcare provider. Interobserver variability of stool assessment with the BITSS between the patient's parent and healthcare providers will be assessed. ETHICS AND DISSEMINATION: The study will be approved by the Ethics Committee of the participating centres. The findings of this study will be submitted to a peer-reviewed journal. Abstracts will be submitted to national and international conferences. TRIAL REGISTRATION NUMBER: NCT02913950.

Costs associated with functional gastrointestinal disorders and related signs and symptoms in infants: a systematic review protocol.

INTRODUCTION: Functional gastrointestinal disorders (FGIDs) and FGID-related signs and symptoms have a fundamental impact on the psychosocial, physical and mental well-being of infants and their parents alike. Recent reviews and studies have indicated that FGIDs and related signs and symptoms may also have a substantial impact on the budgets of third-party payers and/or parents. The objective of this systematic review is to investigate these costs. METHODS AND ANALYSIS: The population of interest is healthy term infants (under 12 months of age) with colic, regurgitation and/or functional constipation. Outcomes of interest will include the frequency and volume of reported treatments, the cost to third-party payers and/or parents for prescribed or over the counter treatments, visits to health professionals and changes in infant formula purchases, and the loss of income through time taken off work and out of pocket costs. Relevant studies will be identified by searching databases from 2005 onwards (including MEDLINE, EMBASE, PsycINFO, NEXIS, DARE, Health Technology Assessment database, National Health Service Economic Evaluation Database and others), conferences from the previous 3 years and scanning reference lists of eligible studies. Study selection, data extraction and quality assessment will be conducted by two independent reviewers and disagreements resolved in discussion with a third reviewer. Quality assessment will involve study design-specific checklists. Relevant studies will be summarised narratively and presented in tables. An overview of treatments and costs will be provided, with any geographical or other differences highlighted. An assessment of how the totals for cost differ across countries and elements that contribute to the differences will be generated. ETHICS AND DISSEMINATION: This is a systematic review of published studies that will be submitted for publication to a peer-reviewed journal. Ethical committee approval is not required. TRIAL REGISTRATION NUMBER: CRD42016033119.

Health-related quality of life in pediatric patients with functional and organic gastrointestinal diseases.

OBJECTIVE: To compare health-related quality of life (HRQOL) in pediatric patients with functional gastrointestinal disorders (FGIDs) and organic gastrointestinal (GI) diseases with an age-, sex-, and race/ethnicity-matched healthy sample across GI diagnostic groups and with one another. STUDY DESIGN: The Pediatric Quality of Life Inventory 4.0 Generic Core Scales were completed in a 9-site study by 689 families. Patients had 1 of 7 physician-diagnosed GI disorders: chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn's disease, ulcerative colitis, and gastroesophageal reflux disease. The healthy control sample included 1114 families. School days missed, days in bed and needing care, parent missed workdays, work impact, and healthcare utilization were compared as well. RESULTS: Patients with an FGID or organic GI disease demonstrated lower HRQOL than the healthy controls across all dimensions (physical, emotional, social, and school; P < .001 for all), with larger effect sizes for patients with an FGID. Patients with an FGID manifested lower HRQOL than those with an organic GI disease. Patients with an FGID or organic GI disease missed more school, spent more days in bed and needing care, had greater healthcare utilization, and had parents who missed more workdays with greater work impact (P < .001 for most), with larger effect sizes for the patients with an FGID. CONCLUSION: Patients with an FGID or organic GI disease demonstrate impaired HRQOL compared with healthy children. HRQOL can be used as a common metric to compare patient outcomes in clinical research and practice both within and across groups of patients with FGIDs and organic GI diseases.

Assessment of abdominal pain through global outcomes and recent FDA recommendations in children: are we ready for change?

OBJECTIVES: Irritable bowel syndrome is a multisymptom construct, with abdominal pain (AP) acting as the driving symptom of patient-reported severity. The Food and Drug Administration considers a >30% decrease in AP as satisfactory improvement, but this has not been validated in children. We investigated the correspondence of 2 measures for AP assessment, ≥30% improvement in AP and global assessment of improvement. METHODS: Secondary analysis of data from 72 children who completed a randomized clinical trial for abdominal pain-associated functional gastrointestinal disorders. Children completed daily assessment of AP intensity, functional disability inventory (FDI), question regarding pain's interference with activities, and 2 global assessment questions. We measured the extent to which ≥30% improvement of AP and global assessment questions correlated with each other and with disability. RESULTS: The global questions correlated with each other (r=0.74; P<0.0001) and with a ≥30% improvement in AP (P<0.01). Global outcomes were satisfaction with treatment was inversely related to the child's report of interference with activities (P<0.01) and symptom relief was positively associated with ≥30% improvement in FDI scores (P<0.009). A 30% change in FDI scores was associated with global questions of symptom relief (P=0.009) but not with satisfaction with treatment (P=0.07). The association of AP improvement with interference with activities (P=0.14) or change in FDI scores (P=0.27) did not reach significance. CONCLUSIONS: Currently used global assessments are significantly associated with decreased pain intensity, decreased interference with daily activities, and a ≥30% change in FDI scores, whereas recommended 30% improvement in pain intensity is not as comprehensive.

Yield and cost of performing screening tests for constipation in children.

BACKGROUND: Chronic constipation is one of the most common reasons for pediatric outpatient visits. Clinical guidelines recommend that the work-up for chronic refractory constipation include thyroid function tests, celiac serology, and measurement of calcium and lead levels. Data to justify routine screening of constipated children using these laboratory tests are lacking. OBJECTIVES: To study the prevalence of celiac disease, hypothyroidism, hypercalcemia and lead poisoning in children with chronic constipation; and to estimate the health care costs of applying the guideline recommendations. METHOD: Charts of constipated children from 2007 to 2011 were reviewed for the present retrospective cohort study. Results and costs of thyroid function tests, celiac panel, total immunoglobulin (Ig) A, and determination of lead and calcium levels were analyzed. RESULTS: A total of 7472 children (mean age 7.9 years; 3908 female) were evaluated: 1731 patients were screened for celiac antibodies; 55 had elevated tissue transglutaminase IgA levels and 29 had biopsy-positive celiac disease. Only three celiac patients had constipation as the sole presenting symptom; 1703 patients were screened for total IgA levels; 55 had IgA deficiency and two had biopsy-positive celiac disease; 2332 had free T4 and/or thyroid-stimulating hormone levels; and 14 had hypothyroidism. Only two patients had constipation as the sole presenting symptom; 4651 patients had calcium levels measured, 10 of whom had high levels but normal repeat values. Three patients had normal lead levels. The mean cost per patient was USD$1,014. Total screening cost for all patients was USD$4.7 million. CONCLUSION: Constipation alone did not increase the likelihood of celiac disease or hypothyroidism above the population prevalence. No benefit of screening for hypercalcemia was found. High health care costs were associated with the use of screening tests for organic constipation.

Seasonal patterns of abdominal pain consultations among adults and children.

BACKGROUND AND AIM: Consultations for chronic abdominal pain are frequent in adults and children. A seasonal pattern of abdominal pain consultations with winter predominance was shown in previous pediatric studies; however, no studies have investigated whether such a pattern exists in adult patients. Understanding the differences in seasonal patterns of abdominal pain consultations among adults and children may indicate that either different mechanisms exist for common chronic pain conditions or triggering factors may vary by age. The aim of the study was to investigate whether a seasonal variation in abdominal pain consultation patterns exists among adults and children. METHODS: The number of outpatient consultations among children (5-17 years) and adults (18 years or older) with a diagnosis of abdominal pain of nonspecified origin (International Classification of Diseases-9 code 789.0) from May 2000 to December 2008 was identified in an administrative claims database. The primary outcome measure was the rate of abdominal pain consultations (total number of abdominal pain consultations/total number of distinct patients by month×1000) by season in children and adults. Seasons were defined as follows: winter (December-February), spring (March-May), summer (June-August), and fall (September-November). A trend test was conducted to determine the degree of linearity in the patterns between the 2 groups. Among children, subanalyses by age 5 to 11 years and 12 to 17 years and sex were conducted. RESULTS: A total of 172.4 million distinct patients (13.4% children, 87.6% adults) were identified in the database between May 2000 and December 2008. During the same time period, 15.6 million patient consultations for abdominal pain were identified (10.1% children, 89.9% adults). Children demonstrated a seasonal pattern in abdominal pain consultations, which best fit a quadratic regression curve, with consultations less common during the summer months. Abdominal pain consultations in adults were linear with no seasonal predominance. The trend in seasonal variation of abdominal pain consultations among children stratified by age and sex remained consistent with the overall child population. CONCLUSIONS: Abdominal pain consultations in children are less common during summer months, whereas no evidence of seasonal pattern of consultation was found in adults. Factors involved in the pathogenesis of abdominal pain in adults and children may differ.

Gastroparesis in children: the benefit of conducting 4-hour scintigraphic gastric-emptying studies.

BACKGROUND AND AIM: Scintigraphic gastric emptying study (GES) is the criterion standard for diagnosis of gastroparesis. Adult studies demonstrated that extending GES to 4 hours increases its ability to diagnose delayed gastric emptying. Most pediatric centers assess GES up to 2 hours postmeal. The aim of the present study was to assess the effect of extending GES from 2 to 4 hours in evaluation of children with suspected gastroparesis. METHODS: We conducted a chart review of all children who had a 4-hour GES with standard radiolabeled solid meal in 2009-2010. Results of GES at 1, 2, and 4 hours were compared. Patients were diagnosed as having gastroparesis using adult criteria: if gastric retention of meal was >90%, 60%, and 10% at 1, 2 and 4 hours, respectively. A telephone survey assessed GES time at top 20 pediatric gastroenterology centers in the United States. Cost of evaluation of patients diagnosed as having gastroparesis was estimated. Full-time equivalents of nuclear medicine technicians and number of nuclear medicine studies done at Ann & Robert H. Lurie Children's Hospital of Chicago from 2007 to 2010 were examined. RESULTS: A total of 71 patients (32 boys, average age 10.8 years) were studied. Sixty-two percent (n=44) children had abnormal GES; 23% (8/35) of them who had normal values at 2 hours had abnormal GES at 4 hours (P<0.0001). Twenty-eight percent of patients had delayed GES at 1 hour: all persisted to have abnormal GES at 2 and 4 hours. Cost of evaluation of a child for gastroparesis was $9014. Only 5 of the top 20 pediatric gastroenterology centers in the United States conducted 4-hour GES. Transitioning from 2 hours to 4 hours only required scheduling adjustments and did not result in limitation in the number of scheduled patients. CONCLUSIONS: Extending GES to 4 hours results in a considerable increase in diagnosis of gastroparesis.

How reliable are the Rome III criteria for the assessment of functional gastrointestinal disorders in children?

OBJECTIVES: Functional gastrointestinal disorders (FGIDs) are common in children. Diagnosis of these conditions is based on the pediatric Rome criteria. In the past, we have shown that there was low inter-rater reliability (IRR) among pediatric gastroenterologists using the Rome II criteria. Since then, a new version of the criteria has been issued. The reliability of the Rome III criteria has not been established. METHODS: A total of 10 pediatric gastroenterologist specialists and 10 pediatric gastroenterology fellows were provided with 20 clinical vignettes and a list of 17 possible diagnoses (all pediatric categories of the Rome criteria plus "none of the above" or "not enough information") and instructed to select one or more diagnosis for each vignette. RESULTS: The average percentage of agreement among the raters was 50% for the pediatric gastroenterologists and 45% for the pediatric gastroenterology fellows. The inter-rater percentage of agreement per clinical case was >50% in only 7 out of 20 (35%) vignettes for the gastroenterologists and only 6 out of 20 (30%) cases for the fellows. The inter-rater percentage of agreement was <25% in 2 out of 20 (10%) vignettes for the gastroenterologists and 4 out of 20 (20%) vignettes for the fellows. The κ coefficient was 0.45 for the specialists (P<0.0001) and 0.39 for the fellows (P<0.0001). In a subanalysis of the groups of pain and constipation-related disorders, the inter-rater percentage of agreement per clinical case ranged between 27 and 100% (mean 57%, κ=0.37, P<0.0001) for the gastroenterologists and between 36 and 80% (mean 52%, κ=0.33, P<0.0001) for the fellows in the constipation subgroup. The inter-rater percentage of agreement per clinical case for the pain subgroup ranged between 22 and 80% (mean 48%, κ=0.36, P<0.0001) for the gastroenterologists and 22 and 62% (mean 39%, κ=0.29, P<0.0001) for the fellows in the pain subgroup. The κ coefficient for specialists with expertise in FGIDs was 0.37 (P<0.0001) and for those with expertise in other gastroenterology conditions was 0.53 (P<0.0001). CONCLUSIONS: The IRR among pediatric gastroenterologists and fellows was found to be fair to moderate for the Rome III criteria. Only slight to fair agreement between raters existed for important subcategories of pain and constipation. The results from our current study are almost similar to that of the IRR study done for the Rome II criteria. This indicates the need for further refinement of the Rome criteria to make them more encompassing and user friendly.

A million-dollar work-up for abdominal pain: is it worth it?

BACKGROUND AND AIM: Pain-predominant-functional gastrointestinal disorders (PP-FGIDs) are common. The diagnosis is clinical and there are no biological markers to characterize these conditions. Despite limited evidence, investigations are commonly performed. The aim of the study was to investigate diagnostic practices, yield, and costs in children with PP-FGIDs. PATIENTS AND METHODS: Charts of all of the children older than 4 years diagnosed as having abdominal pain were reviewed. Results and costs of diagnostic investigations were analyzed. RESULTS: Of 243 children with abdominal pain, 122 (50.2%) had PP-FGIDs (79 girls, mean age 12.7 years). All of the children underwent diagnostic work-up. Complete blood cell count was done in 91.8% of patients. None had elevated white blood cells, platelets, and low albumin. Six had either elevated erythrocyte sedimentation rate or C-reactive protein, but none had elevation of both; 4 of these 6 cases underwent endoscopies with normal results in 3 cases; Helicobacter pylori was found in 1 case. One child had elevated tissue transglutaminase 1 only antibodies with normal endoscopy. Amylase, lipase, direct bilirubin, stool cultures, and ova or parasites were always normal. One child had intermittent elevation of aspartate aminotransferase and alanine transaminase. There were no significant abnormalities in urinalysis or electrolytes. Abdominal x-rays were done in 38.5%, showing only retained stools in 13% of these patients. Abdominal ultrasound and computed tomography scan were done in 23.7% and 9% of cases, respectively, but were of no clinical value; 33.6% patients had esophagogastroduodenoscopy (9.7% abnormal: Helicobacter pylori, chemical gastritis, esophagitis) and 17.2% had colonoscopy (9.5% abnormal: rare fork crypts, lymphoid hyperplasia). Total costs: $744,726. Average cost per patient: $6104.30. CONCLUSIONS: In children with PP-FGIDs, investigations are common, costs are substantial, and yield is minimal.

A prospective school-based study of abdominal pain and other common somatic complaints in children.

OBJECTIVE: To determine the prevalence and impact of pediatric abdominal pain (AP). STUDY DESIGN: Prospective cohort study (12/2005-06/2006), with gastrointestinal and other symptoms assessed weekly. Anxiety, depression, functional disability, quality of life, somatization, coping, school absenteeism and medical care were assessed in 237 students in the third through eighth grades (11.8 years; 134 girls) from 2 public schools weekly. Complete data were obtained on 4606 of 5175 (89%) possible questionnaires. RESULTS: Seventy-two percent of children reported >1 somatic symptom weekly, and 45% of children reported >1 gastrointestinal symptom weekly. The weekly prevalence of AP was 38%, and 90% of children reported AP at least once. AP persisted >4 consecutive weeks in 52% of children and was associated with higher anxiety (P < .001) and depression (P < .001) scores and worse quality of life (P < .001). Twenty-three percent of children missed school for AP (average, 2.3 days), and 10% of parents of those children missed work (average, 1.9 days). Presence of AP (P < .001) was independently associated with school absences. Four children (2%) sought medical attention. CONCLUSIONS: AP is common in school-age children and is associated with worse quality of life, psychological co-morbidities, school absenteeism, and parental work absences.

Cost and consultation patterns of abdominal pain in Uruguayan children.

BACKGROUND: Children with abdominal pain (AP) have worse quality of life and poorer social functioning and school attendance than their healthy peers. This is the first investigation of consultation patterns and costs of AP in South American children. PATIENTS AND METHODS: All data were collected from Unidad Coronaria Movil in Montevideo, Uruguay. Diagnoses of all house calls during a 4-year period (January 2002 through December 2005) were analyzed. Variances in consultation patterns based on sex and age were investigated. Supply and personnel costs were analyzed and prorated to obtain an accurate estimate of the cost per house call and outpatient visit. RESULTS: A total of 125,945 in-home visits and 1588 outpatient consultations were analyzed. Consultation rates for AP peaked among patients 7 to 9 years of age. Female subjects 9 to 14 years of age consulted significantly more frequently for AP than male subjects in the same age group. The average AP consultation accounted for approximately 3.8% of the per capita health care spending in Uruguay in 2005. CONCLUSIONS: AP is a global health problem that is present across ethnicities, nationalities, and geographic locations and is associated with significant health care expenditure.