Prevalence and Risk Factors of Functional Gastrointestinal Disorders: A Cross-Sectional Study in Italian Infants and Young Children.

OBJECTIVES: Reports of prevalence of functional gastrointestinal disorders (FGIDs) in infants/toddlers are widely variable. Reasons for this variability are not yet fully understood. The objective of this study is to estimate the prevalence of FGIDs according to Rome IV criteria and to evaluate associated factors, in Italian infants and toddlers. METHODS: Subjects aged 0-48 months were enrolled by general pediatricians from 3 Italian regions. Parents or legal guardians were administered questionnaires including information about the child, the family, and GI symptoms according to Rome IV criteria. RESULTS: Five hundred eight infants aged 0-12 months [mean age 4.4 ± 3.4 months; females (F) 40.9%], and 268 children aged 13-48 months (mean age 30.8 ± 10.7 months; F 44.4%) were included. In infants, prevalence of FGIDs was 21.1%, and the most prevalent FGID was infant colic (9.3%). In toddlers, prevalence of FGIDs was 19.6%, with functional constipation being the most frequent disorder (16.1%). In infants, multivariable analysis found that being older, being the only child, and living in a rural environment were associated with a lower rate of FGIDs. Prevalence was, in contrast, higher in infants fed with formula. CONCLUSIONS: One out of 5 Italian infants and young children is affected by at least 1 FGID. The most frequent FGID in infants is infant colic, while in toddlers this is functional constipation. In infants, prevalence of FGIDs is lower if the subject has no siblings, and in children living in a rural environment, while formula feeding represents a risk factor for FGIDs occurrence.

Prevalence of Functional Gastrointestinal Disorders in European Infants and Toddlers.

OBJECTIVE: To assess the prevalence of functional gastrointestinal disorders (FGIDs) in young children in a cross-sectional, multicenter study in Belgium, Italy, and The Netherlands. STUDY DESIGN: Children were enrolled if they were age 0-48 months, attending a general pediatrician (Belgium, Italy) or a well-baby clinic (The Netherlands) for routine follow-up. Separate questionnaires were developed for infants age 0-12 months and for toddlers age 13-48 months. Questionnaires evaluated the clinical history, symptoms, sociodemographic information on the family, and exposure to stressful life events. FGIDs were defined according to Rome IV criteria. RESULTS: In total 2751 children were included: 1698 infants age 0-12 months and 1053 children age 13-48 months. The prevalence of any FGID in infants age 0-12 months and 13-48 months was 24.7% and 11.3%, respectively. The most common disorders were infant regurgitation (13.8%) in infants and functional constipation (9.6%) in toddlers. Multivariable regression analyses demonstrated that younger age (P = .030) and formula feeding (P = .045) were associated with the prevalence of any FGID among infants. Country (Italy) (P = .033) and parents subjected to domestic violence (P = .035) were associated with the prevalence of any FGID in toddlers age 13-48 months. CONCLUSIONS: FGIDs are common in a community sample of Western European infants and toddlers. Regurgitation is most prevalent in infants and functional constipation is most common in toddlers. Younger age, formula feeding, and domestic violence to parents are associated with the prevalence of FGIDs.

Development of a Core Outcome Set for Infant Gastroesophageal Reflux Disease.

OBJECTIVE: In therapeutic trials for infant gastroesophageal reflux disease (GERD), ways to define GERD and measure and report study outcomes vary widely. The aim of this study was to develop a core outcome set (COS) for infant GERD. METHODS: The COS was developed using the Delphi technique, adhering to the Outcome Measures in Rheumatology Initiative 2.0 recommendations. Healthcare professionals (HCPs) (predominantly pediatric gastroenterologists and general pediatricians) and parents of infants (age 0-12 months) with GERD, listed up to 5 primary goals of therapy from their perspective and up to 5 persistent signs or symptoms that would signify inadequate treatment. Outcomes mentioned by >10% of participants were included in 2 shortlists. Next, HCPs and parents rated and prioritized outcomes on these shortlists. Outcomes with the highest rank formed the draft COS. The final COS was created after 2 consensus meetings between an expert panel and patient representatives. RESULTS: In total, 125 of 165 HCPs (76%) and 139 of 143 parents (97%) of infants with GERD completed the first phase. The second phase was completed by 83 of 139 HCPs (60%) and 127 of 142 different parents (89%). Outcomes of these phases were discussed during the consensus meetings and a 9-item COS was formed: "Adequate Growth," "Adequate Relief," "Adverse events,", "Crying," "Evidence of Esophagitis," "Feeding Difficulties," "Hematemesis," "No Escalation of Therapy," and "Sleep Problems." CONCLUSIONS: We developed a COS for infant GERD consisting of 9 items that should minimally be measured in future therapeutic trials to decrease study heterogeneity and ease comparability of results.

A Multifaceted Intervention to Reduce Pediatric Acid-Suppressant Prescriptions for Gastroesophageal Reflux: What Have We Learned?

OBJECTIVE: Acid-suppressant prescriptions for children have increased over past decades, despite guideline recommendations to prescribe prudently. Acid suppressants are often ineffective and may lead to side effects. We aimed to reduce inappropriate acid-suppressant prescriptions for gastroesophageal reflux in a tertiary care setting through active implementation of national guideline recommendations and to evaluate intervention effect. METHODS: Implementation consisted of 2 steps. First, all pediatric clinicians in an academic hospital received information on appropriate acid-suppressant prescribing, a link to an online national guideline application and summary card with important evidence-based recommendations-Wise Choices. Hereafter, clinicians prescribing acid suppressants were contacted to provide feedback on indications and to assess their knowledge of the guideline and Wise Choices. The pharmacy database supplied prescription data before, during, and after this intervention. RESULTS: During the study period prescriptions ranged from 115 to 201/month. Ten months postintervention, a nonsignificant decrease of 4 prescriptions/month was measured (95% confidence interval -49-41). Of the 78 prescribers 76 were successfully contacted: 63% were familiar with the guideline and 45% with Wise Choices. Thirty percent of prescriptions were for gastroesophageal reflux symptoms. CONCLUSION: This multifaceted implementation strategy did not lead to a significant difference in acid-suppressant prescriptions by tertiary care clinicians of whom the majority was familiar with the gastroesophageal reflux disease guideline. Future studies should clarify, which implementation strategies are most effective in reducing inappropriate prescribing of acid suppressants for children. Uniform registration of prescriptions and indications in a national database will enable monitoring of the intervention effect.

Variations in Definitions and Outcome Measures in Gastroesophageal Reflux Disease: A Systematic Review.

CONTEXT: Gastroesophageal reflux (GER) is defined as GER disease (GERD) when it leads to troublesome symptoms and/or complications. We hypothesized that definitions and outcome measures in randomized controlled trials (RCTs) on pediatric GERD would be heterogeneous. OBJECTIVES: Systematically assess definitions and outcome measures in RCTs in this population. DATA SOURCES: Data were obtained through Cochrane, Embase, Medline, and Pubmed databases. STUDY SELECTION: We selected English-written therapeutic RCTs concerning GERD in children 0 to 18 years old. DATA EXTRACTION: Data were tabulated and presented descriptively. Each individual parameter or set of parameters with unique criteria for interpretation was considered a single definition for GER(D). Quality was assessed by using the Delphi score. RESULTS: A total of 2410 unique articles were found; 46 articles were included. Twenty-six (57%) studies defined GER by using 25 different definitions and investigated 25 different interventions. GERD was defined in 21 (46%) studies, all using a unique definition and investigating a total of 23 interventions. Respectively 87 and 61 different primary outcome measures were reported by the studies in GER and GERD. Eight (17%) studies did not report on side effects. Of the remaining 38 (83%) studies that did report on side effects, 18 (47%) included this as predefined outcome measure of which 4 (22%) as a primary outcome measure. Sixteen studies (35%) were of good methodological quality. LIMITATIONS: Only English-written studies were included. CONCLUSIONS: Inconsistency and heterogeneity exist in definitions and outcome measures used in RCTs on pediatric GER and GERD; therefore, we recommend the development of a core outcome set.

Developing a core outcome set for infant colic for primary, secondary and tertiary care settings: a prospective study.

OBJECTIVE: Infant colic (IC) is defined as recurrent and prolonged crying without an obvious cause or evidence of failure to thrive or illness. It is a common problem with a prevalence of 5%-25%. The unknown aetiology results in a wide variety in interventions and use of heterogeneous outcome measures across therapeutic trials. Our aim was to develop a core outcome set (COS) for IC to facilitate and improve evidence synthesis. DESIGN AND SETTING: Prospective study design; primary, secondary and tertiary care. METHODS: The COS was developed using a modified Delphi technique. First, healthcare professionals (HCPs) and parents of infants with IC were asked to list up to five outcomes they considered relevant in the treatment of IC. Outcomes mentioned by >10% of participants were forwarded to a shortlist. In the second round, outcomes on this shortlist were rated and prioritised. The final COS was defined in a face-to-face expert meeting of paediatricians. RESULTS: F of invited stakeholders (133 HCPs and 55 parents of infants with IC) completed both Delphi rounds. Duration of crying, family stress, sleeping time of infant, quality of life (of family), discomfort of infant and hospital admission/duration were rated as most important outcomes in IC, framing the final COS. CONCLUSIONS: The use of this COS should serve as a minimum of outcomes to be measured and reported. This will benefit evidence synthesis, by enhancing homogeneity of outcomes, and enable evaluation of success in therapeutic trials on IC. Researchers are strongly encouraged to use this COS when setting up a clinical trial in primary, secondary and/or tertiary care or performing a systematic review on IC.

Reporting outcome measures in trials of infant colic.

OBJECTIVES: Infant colic (IC), with an estimated prevalence of 5% to 25%, has a high impact on health care costs. Furthermore, reported negative sequelae are disturbed parent-infant interaction, increased susceptibility to abdominal pain, and even child abuse. Its etiology remains unknown, leading to a wide variety in interventions. We hypothesize that definitions and outcome measures in studies on IC will be heterogeneous as well. Our objective is to systematically assess how definitions and outcome measures are reported in randomized controlled trials (RCTs) of IC. METHODS: CENTRAL, Embase, and MEDLINE/PubMed were searched from inception to December 2012. English-language systematic reviews (SRs) and RCTs concerning IC in children ages 0 to 9 months were included. Bibliographies of included SRs were searched for additional articles. Quality was assessed using the Delphi list. RESULTS: A total of 1702 studies were found; 55 articles were included (16 SRs, 39 RCTs). In 39 trials, we found 20 different definitions for IC, 11 different definitions for improvement, 28 different interventions, and 19 different outcomes. Fifty-one percent of the trials were of good methodological quality. All of the trials used parental diaries; only 31% stated that their instrument was validated. CONCLUSIONS: Too many different definitions and outcome measures for IC are used in RCTs. Only a minority of the trials reported parental perception as primary outcome. Uniform definitions, outcomes, and validated instruments are needed to make a comparison between intervention studies possible.