Pediatric Rectal Exam: Why, When, and How.

The digital rectal examination (DRE) is performed in children less often than is indicated. Indications for the pediatric DRE include diarrhea, constipation, fecal incontinence, abdominal pain, gastrointestinal bleeding, and anemia. Less well-recognized indications may include abdominal mass, urinary symptoms, neurologic symptoms, urogenital or gynecologic symptoms, and anemia. Indeed, we believe that it should be considered part of a complete physical examination in children presenting with many different complaints. Physicians avoid this part of the physical examination in both children and adults for a number of reasons: discomfort on the part of the health care provider; belief that no useful information will be provided; lack of adequate training and experience in the performance of the DRE; conviction that planned "orders" or testing can obviate the need for the DRE; worry about "assaulting" a patient, particularly one who is small, young, and subordinate; anticipation that the exam will be refused by patient or parent; and concern regarding the time involved in the exam. The rationale and clinical utility of the DRE will be summarized in this article. In addition, the components of a complete pediatric DRE, along with suggestions for efficiently obtaining the child's consent and cooperation, will be presented.

Development and psychometric evaluation of 2 age-stratified versions of the Pediatric GERD Symptom and Quality of Life Questionnaire.

OBJECTIVES: The Pediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) represents 2 related age-stratified tools developed to assess pediatric gastroesophageal reflux disease (GERD). These include the PGSQ-Cp (for children ages 2 to 8 years, parent/caregiver report) and the PGSQ-A (for adolescents ages 9-17 years). The objective of the present study was to develop and evaluate PGSQ measurement properties. MATERIALS AND METHODS: The PGSQ items were generated based on information from focus groups, expert clinician review, and cognitive debriefing interviews. The symptoms of pediatric GERD and the effect of these symptoms were addressed. The tools were evaluated in a 3-week psychometric evaluation with participants from 11 clinical sites in the United States. The study included other measures such as the Pediatric Quality of Life questionnaire (PedsQL) and clinician-rated GERD severity. After item reduction, internal consistency, reproducibility, construct validity, known-group validity, and responsiveness were assessed. RESULTS: The 231 participants included 75 parents of children ages 2 to 8 years and 75 children ages 9 to 17 years with GERD and 41 parents of children and 40 children ages 9 to 17 years without GERD. Exploratory factor analysis demonstrated 4 symptom subscales for the PGSQ-Cp and 3 symptom subscales for the PGSQ-A. Both had subscales for total impact and school impact. High to moderate internal consistency was observed, ranging from 0.76 to 0.96 for the PGSQ-Cp and from 0.67 to 0.94 for the PGSQ-A. The PGSQ significantly differentiated between patients with GERD and controls (P < 0.0001, PGSQ-Cp; P < 0.0022-0.0001, PGSQ-A) and demonstrated responsiveness. CONCLUSIONS: These results support the reliability, validity, and responsiveness of both versions of the PGSQ. The instruments should be useful for clinical studies.

Symptoms and reflux in infants: Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)--utility for symptom tracking and diagnosis.

Answering a need for a thoroughly validated infant gastroesophageal reflux questionnaire, the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) was designed, refined, and validated using state-of-the-art psychometric methods. Diagnostic and evaluative (tracking) validity was identified. However, perplexing results of some clinical trials using the I-GERQ-R for diagnosis prompted analysis of possible reasons, including ambiguities in defining symptomatic gastroesophageal reflux disease (GERD) and aspects of the validation process. Symptomatic GERD is defined by "troublesomeness" of symptoms and attribution of their causation to reflux--two crucial issues. Methods of quantifying symptom-reflux associations are described and their limitations identified. The location of "symptomatic esophageal GERD" in the continuum of erosive GERD, histologic GERD, and nonerosive reflux disease is indicated, with the last including "suberosive," "premicroscopic," and "functional heartburn" subcategories. Another category is defined solely by surrogate measures of propensity to GERD (e.g., acid exposure thresholds defined on esophageal pH monitoring). During diagnostic validation of the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) instruments, asymptomatic normals were contrasted with symptomatic GERD infants (who also tested positive with esophageal histology and esophageal pH monitoring). However, the diagnostic validation did not attempt to distinguish symptomatic GERD infants from symptomatic infants without GERD. The I-GERQ-R is thus adequately sensitive to be used diagnostically to screen infants for symptom burden, but should probably be supplemented by other, perhaps invasive, testing to assure appropriate specificity. The I-GERQ-R's validation for evaluative properties, however, supports its use for tracking symptoms within clinical trials.

Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease.

OBJECTIVE: To assess the efficacy and safety of lansoprazole in treating infants with symptoms attributed to gastroesophageal reflux disease (GERD) that have persisted despite a >or= 1-week course of nonpharmacologic management. STUDY DESIGN: This multicenter, double-blind, parallel-group study randomized infants with persisting symptoms attributed to GERD to treatment with lansoprazole or placebo for 4 weeks. Symptoms were tracked through daily diaries and weekly visits. Efficacy was defined primarily by a >or= 50% reduction in measures of feeding-related crying and secondarily by changes in other symptoms and global assessments. Safety was assessed based on the occurrence of adverse events (AEs) and clinical/laboratory data. RESULTS: Of the 216 infants screened, 162 met the inclusion/exclusion criteria and were randomized. Of those, 44/81 infants (54%) in each group were responders--identical for lansoprazole and placebo. No significant lansoprazole-placebo differences were detected in any secondary measures or analyses of efficacy. During double-blind treatment, 62% of lansoprazole-treated subjects experienced 1 or more treatment-emergent AEs, versus 46% of placebo recipients (P= .058). Serious AEs (SAEs), particularly lower respiratory tract infections, occurred in 12 infants, significantly more frequently in the lansoprazole group compared with the placebo group (10 vs 2; P= .032). CONCLUSIONS: This study detected no difference in efficacy between lansoprazole and placebo for symptoms attributed to GERD in infants age 1 to 12 months. SAEs, particularly lower respiratory tract infections, occurred more frequently with lansoprazole than with placebo.

Eosinophilic gastroenteritis.

Eosinophilic gastroenteritis is an infrequently diagnosed condition that is characterized by prominent eosinophilic infiltration of the stomach or small intestine, generally localized to one level of the intestinal wall; the variable organ locus and wall depth produce heterogeneous clinical presentations. A strong association with atopy is present in most cases, supported by circumstantial evidence and the demonstration of Th-2 proinflammatory cytokine profiles in animal studies. A high degree of suspicion is required to establish the diagnosis, which must be based on intense gastrointestinal eosinophilia. Management is directed toward removal of offending allergens and use of anti-inflammatory agents. Novel and emerging treatments on the horizon are biologic therapies and selective anti-eosinophil agents.

Efficacy of conservative therapy as taught in the primary care setting for symptoms suggesting infant gastroesophageal reflux.

OBJECTIVE: To determine the efficacy of non-pharmacologic conservative therapy for infant gastroesophageal reflux disease (GERD). STUDY DESIGN: Consenting parents of the first 50 screened infants who met inclusion/exclusion criteria including abnormal (>16/42) scores on the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R; n = 40) were taught conservative therapy measures by each site's study nurse: feeding modifications, positioning, and tobacco smoke avoidance. We compared I-GERQ-R scores and symptom response details before and 2 weeks after institution of these measures with 2-tail Wilcoxon signed ranks test in the 37 infants (age range, 4-43 weeks; median age, 13 weeks) who completed the run-in. RESULTS: The median initial and final scores were 23 (16-36) and 18 (7-34; P < .000001). The median score change was -5 (+6--16). Scores of 78% improved at all; 59% improved at least the threshold of 5 points; 24% became normal. Scores for individual symptoms related to regurgitation, crying, and arching improved significantly. CONCLUSIONS: Two weeks of conservative therapy measures taught in primary care improved 59% beyond the 5-point threshold and normalized 24% of infants with symptom severity diagnostic for GERD, as substantiated with a responsiveness-validated instrument.

Educational clinical case series in pediatric allergy and immunology.

Eosinophilic inflammation may occur in any part of the intestinal tract from the esophagus to the rectum. Despite 70 yr having passed since the first reference to a case of eosinophilic gastroenteritis, the epidemiology and natural history of eosinophilic gastrointestinal disorders are still poorly known. Insights into their etiology and pathogenesis have revealed an important role for allergens; interleukins 4, 5, and 13; the eotaxin family of chemokines; and eosinophil-derived proteins. Diagnosis is confirmed by typical histologic features in a patient with a suggestive clinical phenotype. Treatment involves eliminating triggering allergens, making dietary restrictions the first choice of therapy in a compliant patient; corticosteroids [topical in eosinophilic esophagitis (EE)], despite the potential for serious side effects, are used with success in refractory and non-compliant patients. In this study we discuss EE and gastroduodenitis against the backdrop of clinical case presentations.

Infant apnea and gastroesophageal reflux: a critical review and framework for further investigation.

Gastroesophageal reflux and apnea of prematurity are both common occurrences in premature infants. However, a causal relationship between the two remains controversial. Strong physiologic evidence indicates that a variety of protective reflex responses may elicit laryngeal adduction and apnea. Although a potential link between gastroesophageal reflux and apnea may exist through this pathway, clinical studies can be cited to either support or refute such a link in premature infants. The majority of gastroesophageal reflux episodes do not appear to be related to apnea. In a specific subset of events, a causal relationship may exist. Whether this is related to the character of the reflux episode or to a predisposition in a subpopulation of infants is unclear. This review presents the evidence for and against an association between gastroesophageal reflux and apnea, discusses techniques used in their evaluation, and identifies approaches for future investigation.

Pediatric erosive esophagitis maintenance: finally, some level 1 evidence!

In children, as in adults, gastroesophageal reflux disease (GERD), particularly erosive esophagitis, is now believed to be a chronic disease, probably requiring lifelong maintenance therapy. However, this assumption has not received adequate clinical testing, and the provocative article by Boccia et al. in this issue of the Journal challenges it. The strengths of this exceptional pediatric study lie in its prospective, controlled, randomized character, and in its relatively long duration of prospective follow-up. Weaknesses of the study include its limited power and lack of prior validation of outcome measures. The conclusions of the study are applicable only to children without chronic neurologic, respiratory, or congenital esophageal abnormalities, the children for whom chronic proton pump inhibitors (PPIs) are most often required. The study's provocative results might be explained by the fundamental lack of GERD chronicity in otherwise healthy children, combined with absence of the PPI dependence that can be produced when PPIs are used chronically for chronic disease.

Morphometric histology for infant gastroesophageal reflux disease: evaluation of reliability in 497 esophageal biopsies.

OBJECTIVES: We sought to determine the reliability of morphometric measurements on infant esophageal biopsies using a light microscope with eyepiece micrometer. METHODS: We measured epithelial thickness, basal layer thickness (B), papillary height (P) and epithelial lymphocyte and eosinophil numbers on approximately 500 existing esophageal suction biopsies from infants previously evaluated for reflux esophagitis. We tested these measurements for interobserver, test-retest and internal consistency reliability. RESULTS: Infants ages 0.25 to 23.75 (median, 6.25) months provided 497 biopsies. Both investigators scoring the biopsies independently judged 93% of them scorable. Of the biopsies scored by both, the 2 readings were within 0.15 of each other for P in 97% and for B in 81%. In addition to these correlative measures of consistency, categoric measures demonstrated that 373 (89%) of the 420 scorable biopsies with visible papillae produced agreement as to P being abnormal (317, 85%) or normal (56, 15%). Similarly, 360 (78%) of the 463 scorable biopsies produced agreement as to B being abnormal (339, 94%) or normal (21, 6%). P values were 0.17 to 0.94 (median, 0.67), and B values were 0.13 to 0.91 (median, 0.34). Lymphocytes numbered 0 to 40 (median 5) per high-power field. Only 12% had any eosinophils; none of those with completely normal morphometrics had any eosinophils; and only 2% had >5 eosinophils per high-power field. CONCLUSIONS: Simple quantitative esophageal histological morphometric parameters are reliably measurable on suction biopsies from infants using a light microscope fitted with an ocular micrometer, even by nonpathologists.

The infant gastroesophageal reflux questionnaire revised: development and validation as an evaluative instrument.

BACKGROUND & AIMS: Gastroesophageal reflux disease (GERD) is frequently experienced by infants, and disease-specific measures are needed to evaluate treatment benefits. We revised the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) on the basis of information from parents of infants with GERD and physicians and subjected it to a psychometric evaluation. METHODS: A 3-week, multi-country observational study of 185 caregivers of infants younger than 18 months with GERD and 93 caregivers of control infants was conducted. Caregivers completed the I-GERQ-R weekly and recorded symptoms in a Daily Diary. Caregivers and physicians rated global disease severity and change in overall GERD symptoms. RESULTS: Slightly more than half of infants were male with a mean age of 6.7 months, and most infants had been diagnosed with GERD for a little more than 2 months (mean, 66.7 days). Internal consistency reliability for the I-GERQ-R ranged from 0.86 to 0.87, and test-retest reliability was 0.85. Construct validity was demonstrated by significant differences between cases and controls on all item scores (all P<.01) and the total score (P<.0001), correlations with relevant Daily Diary symptoms, and both physician-rated (P<.05) and caregiver-rated disease severity (P<.05). Mean baseline to 3-week I-GERQ-R change scores for those infants whose caregivers reported improvement was -5.7 compared with -0.3 for those whose caregivers reported worse/same (P<.001). Physician ratings of change resulted in similar findings, with mean changes of -5.7 for those rated improved and -0.1 for those rated as worse/same (P<.0001). CONCLUSION: This study demonstrated the I-GERQ-R is a reliable, valid, and clinically responsive measure of infant GERD symptoms.