Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS).

BACKGROUND: End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments. OBJECTIVE: We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE. METHODS: Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement. Consensus meetings were held to ratify the outcome domains of importance and the core outcome measures. Stakeholders were recruited internationally and included adult and pediatric gastroenterologists, allergists, dieticians, pathologists, psychologists, researchers, and methodologists. RESULTS: The COS consists of 4 outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life. A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a 2-round Delphi process, and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, Eosinophilic Esophagitis Histology Scoring System, Eosinophilic Esophagitis Endoscopic Reference Score, and patient-reported measures of dysphagia and quality of life. CONCLUSIONS: This interdisciplinary collaboration involving global stakeholders has produced a COS that can be applied to adult and pediatric studies of pharmacologic and diet therapies for EoE and will facilitate meaningful treatment comparisons and improve the quality of data synthesis.

[Ibero-latinamerican clinical practical guidelines on pediatric caustic esophagitis: Physiopathology and clinical-endoscopic diagnosis (1st Part)]. / Guía de práctica clínica Ibero-Latinoamericana sobre la esofagitis cáustica en Pediatría: Fisiopatología y diagnóstico clínico-endoscópico (1a Parte).

Caustic ingestion represents a serious social-medical problem due to the devastating and irreversible consequences it can produce in the upper digestive tract. In Ibero-America, there are no published reliable data on the incidence or prevalence of caustic-induced injuries, and most of the available information on clinical presentation, diagnosis, treatment, and prognosis is based on retrospective clinical series and, indeed, its clinical management is often based primarily on expert opinion. Re cently as an initiative of the Latin American Society for Pediatric Gastroenterology, Hepatology and Nutrition (LASPGHAN) and with the cooperation of the Spanish Society for Pediatric Gastroente rology, Hepatology and Nutrition (SEGHNP), we have designed a Clinical Practice Guideline that include a series of statements and recommendations aimed at optimizing patient medical care which is based on the systematic review of evidence. Two (2) successive papers focused on the evaluation of physiopathological and clinical-endoscopic diagnostic features of caustic esophagitis in children (1st. Paper) and, on the other hand, the most relevant therapeutic considerations (2nd. Paper). We expect this guideline to become a useful tool for the physician in the difficult decision-making process when assessing patients after caustic ingestion.

[Ibero-Latinamerican Clinical Practical Guidelines on pediatric caustic esophagitis: Therapeutical aspects (Part 2)]. / Guía de práctica clínica Ibero-Latinoamericana sobre la esofagitis cáustica en Pediatría: Aspectos terapéuticos (2a. Parte).

Caustic ingestion represents a serious social-medical problem due to the devastating and irreversible consequences it can produce in the upper digestive tract. In Ibero-America, there are no published reliable data on the incidence or prevalence of caustic-induced injuries, and most of the available information on clinical presentation, diagnosis, treatment, and prognosis is based on retrospective clinical series and, indeed, its clinical management is often based primarily on expert opinion. Re cently as an initiative of the Latin American Society for Pediatric Gastroenterology, Hepatology and Nutrition (LASPGHAN) and with the cooperation of the Spanish Society for Pediatric Gastroente rology, Hepatology and Nutrition (SEGHNP), we have designed a Clinical Practice Guideline that include a series of statements and recommendations aimed at optimizing patient medical care which is based on the systematic review of evidence. Two (2) separate papers focused on the evaluation of physiopathological and clinical-endoscopic diagnostic features of caustic esophagitis in children (1st. Paper) and, on the other hand, the most relevant therapeutic considerations (2nd. Paper). We expect this guideline to become a useful tool for the physician in the difficult decision-making process when assessing patients after caustic ingestion.

Guía de práctica clínica Ibero-Latinoamericana sobre la esofagitis cáustica en Pediatría: aspectos terapéuticos (2a. Parte) / Ibero-Latinamerican Clinical Practical Guidelines on pediatric caustic esophagitis: therapeutical aspects (Part 2)

Resumen: La ingestión de cáusticos representa un grave problema médico-social por las consecuencias devastadoras e irreversibles que puede producir en el tracto digestivo superior. En Iberoamérica no se han publicado datos fidedignos sobre la incidencia o la prevalencia de lesiones inducidas por cáusticos. La información disponible sobre la presentación clínica, diagnóstico, tratamiento y pronóstico se basa en series retrospectivas de casos y, de hecho, su manejo clínico se sustenta en muchos casos fundamentalmente en la opinión de expertos. Recientemente como una iniciativa de la Sociedad Latinoamericana de Gastroenterología, Hepatología y Nutrición Pediátrica (SLAGHNP) y con la co laboración de colegas de la Sociedad Española de Gastroenterología, Hepatología y Nutrición Pediá trica (SEGHNP), hemos diseñado una Guía de Práctica Clínica (GPC) la cual incluye una serie de enunciados y recomendaciones dirigidos a optimizar la atención a los pacientes y que se basan en la revisión sistemática de la evidencia. En dos (2) manuscritos sucesivos nos hemos enfocado primero, en los aspectos fisiopatológicos y de diagnóstico clínico-endoscópico de la esofagitis cáustica en niños (1a. Parte) y en segundo lugar, en los aspectos más relevantes del tratamiento (2a. Parte). Esperamos esta guía se convierta en una herramienta útil para el clínico en el difícil proceso de toma de decisio nes a la hora de evaluar un paciente posterior a la ingesta de una sustancia cáustica.

Abstract: Caustic ingestion represents a serious social-medical problem due to the devastating and irreversible consequences it can produce in the upper digestive tract. In Ibero-America, there are no published reliable data on the incidence or prevalence of caustic-induced injuries, and most of the available information on clinical presentation, diagnosis, treatment, and prognosis is based on retrospective clinical series and, indeed, its clinical management is often based primarily on expert opinion. Re cently as an initiative of the Latin American Society for Pediatric Gastroenterology, Hepatology and Nutrition (LASPGHAN) and with the cooperation of the Spanish Society for Pediatric Gastroente rology, Hepatology and Nutrition (SEGHNP), we have designed a Clinical Practice Guideline that include a series of statements and recommendations aimed at optimizing patient medical care which is based on the systematic review of evidence. Two (2) separate papers focused on the evaluation of physiopathological and clinical-endoscopic diagnostic features of caustic esophagitis in children (1st. Paper) and, on the other hand, the most relevant therapeutic considerations (2nd. Paper). We expect this guideline to become a useful tool for the physician in the difficult decision-making process when assessing patients after caustic ingestion.

Guía de práctica clínica Ibero-Latinoamericana sobre la esofagitis cáustica en Pediatría: fisiopatología y diagnóstico clínico-endoscópico (1a Parte) / Ibero-latinamerican clinical practical guidelines on pediatric caustic esophagitis: physiopathology and clinical-endoscopic diagnosis (1st Part)

Resumen: La ingestión de cáusticos representa un grave problema médico-social por las consecuencias devastadoras e irreversibles que puede producir en el tracto digestivo superior. En Iberoamérica no se han publicado datos fidedignos sobre la incidencia o la prevalencia de lesiones inducidas por cáusticos. La información disponible sobre la presentación clínica, diagnóstico, tratamiento y pronóstico se basa en series retrospectivas de casos y, de hecho, su manejo clínico se sustenta en muchos casos fundamentalmente en la opinión de expertos. Recientemente como una iniciativa de la Sociedad Latinoamericana de Gastroenterología, Hepatología y Nutrición Pediátrica (SLAGHNP) y con la co laboración de colegas de la Sociedad Española de Gastroenterología, Hepatología y Nutrición Pediá trica (SEGHNP), hemos diseñado una Guía de Práctica Clínica (GPC) la cual incluye una serie de enunciados y recomendaciones dirigidos a optimizar la atención a los pacientes y que se basan en la revisión sistemática de la evidencia. En dos (2) manuscritos sucesivos nos hemos enfocado primero, en los aspectos fisiopatológicos y de diagnóstico clínico-endoscópico de la esofagitis cáustica en niños (1a. Parte) y en segundo lugar, en los aspectos más relevantes del tratamiento (2a. Parte). Esperamos esta guía se convierta en una herramienta útil para el clínico en el difícil proceso de toma de decisio nes a la hora de evaluar un paciente posterior a la ingesta de una sustancia cáustica.

Abstract: Caustic ingestion represents a serious social-medical problem due to the devastating and irreversible consequences it can produce in the upper digestive tract. In Ibero-America, there are no published reliable data on the incidence or prevalence of caustic-induced injuries, and most of the available information on clinical presentation, diagnosis, treatment, and prognosis is based on retrospective clinical series and, indeed, its clinical management is often based primarily on expert opinion. Re cently as an initiative of the Latin American Society for Pediatric Gastroenterology, Hepatology and Nutrition (LASPGHAN) and with the cooperation of the Spanish Society for Pediatric Gastroente rology, Hepatology and Nutrition (SEGHNP), we have designed a Clinical Practice Guideline that include a series of statements and recommendations aimed at optimizing patient medical care which is based on the systematic review of evidence. Two (2) successive papers focused on the evaluation of physiopathological and clinical-endoscopic diagnostic features of caustic esophagitis in children (1st. Paper) and, on the other hand, the most relevant therapeutic considerations (2nd. Paper). We expect this guideline to become a useful tool for the physician in the difficult decision-making process when assessing patients after caustic ingestion.

Use of Biosimilars in Pediatric Inflammatory Bowel Disease: An Updated Position Statement of the Pediatric IBD Porto Group of ESPGHAN.

Biologic therapies have changed the outcome of both adult and pediatric patients with Inflammatory Bowel Disease (IBD). In September 2013, the first biosimilar of infliximab was introduced into the pharmaceutical market. In 2015, a first position paper on the use of biosimilars in pediatric IBD was published by the ESPGHAN IBD Porto group. Since then, more data have accumulated for both adults and children demonstrating biosimilars are an effective and safe alternative to the originator. In this updated position statement, we summarize current evidence and provide joint consensus statements regarding the recommended practice of biosimilar use in children with IBD.

Pediatric Eosinophilic Esophagitis: Results of the European Retrospective Pediatric Eosinophilic Esophagitis Registry (RetroPEER).

OBJECTIVES: Recommendations for diagnosing and treating eosinophilic esophagitis (EoE) are evolving; however, information on real world clinical practice is lacking. To assess the practices of pediatric gastroenterologists diagnosing and treating EoE and to identify the triggering allergens in European children. METHODS: Retrospective anonymized data were collected from 26 European pediatric gastroenterology centers in 13 countries. Inclusion criteria were: Patients diagnosis with EoE, completed investigations prescribed by the treating physician, and were on stable medical or dietary interventions. RESULTS: In total, 410 patients diagnosed between December 1999 and June 2016 were analyzed, 76.3% boys. The time from symptoms to diagnosis was 12 ±â€Š33.5 months and age at diagnosis was 8.9 ±â€Š4.75 years. The most frequent indications for endoscopy were: dysphagia (38%), gastroesophageal reflux (31.2%), bolus impaction (24.4%), and failure to thrive (10.5%). Approximately 70.3% had failed proton pump inhibitor treatment. The foods found to be causative of EoE by elimination and rechallenge were milk (42%), egg (21.5%), wheat/gluten (10.9%), and peanut (9.9%). Elimination diets were used exclusively in 154 of 410 (37.5%), topical steroids without elimination diets in 52 of 410 (12.6%), both diet and steroids in 183 of 410 (44.6%), systemic steroids in 22 of 410 (5.3%), and esophageal dilation in 7 of 410 (1.7%). Patient refusal, shortage of endoscopy time, and reluctance to perform multiple endoscopies per patient were noted as factors justifying deviation from guidelines. CONCLUSIONS: In this "real world" pediatric European cohort, milk and egg were the most common allergens triggering EoE. Although high-dose proton pump inhibitor trials have increased, attempted PPI treatment is not universal.

Updated International Consensus Diagnostic Criteria for Eosinophilic Esophagitis: Proceedings of the AGREE Conference.

BACKGROUND & AIMS: Over the last decade, clinical experiences and research studies raised concerns regarding use of proton pump inhibitors (PPIs) as part of the diagnostic strategy for eosinophilic esophagitis (EoE). We aimed to clarify the use of PPIs in the evaluation and treatment of children and adults with suspected EoE to develop updated international consensus criteria for EoE diagnosis. METHODS: A consensus conference was convened to address the issue of PPI use for esophageal eosinophilia using a process consistent with standards described in the Appraisal of Guidelines for Research and Evaluation II. Pediatric and adult physicians and researchers from gastroenterology, allergy, and pathology subspecialties representing 14 countries used online communications, teleconferences, and a face-to-face meeting to review the literature and clinical experiences. RESULTS: Substantial evidence documented that PPIs reduce esophageal eosinophilia in children, adolescents, and adults, with several mechanisms potentially explaining the treatment effect. Based on these findings, an updated diagnostic algorithm for EoE was developed, with removal of the PPI trial requirement. CONCLUSIONS: EoE should be diagnosed when there are symptoms of esophageal dysfunction and at least 15 eosinophils per high-power field (or approximately 60 eosinophils per mm2) on esophageal biopsy and after a comprehensive assessment of non-EoE disorders that could cause or potentially contribute to esophageal eosinophilia. The evidence suggests that PPIs are better classified as a treatment for esophageal eosinophilia that may be due to EoE than as a diagnostic criterion, and we have developed updated consensus criteria for EoE that reflect this change.

Use of Biosimilars in Paediatric Inflammatory Bowel Disease: A Position Statement of the ESPGHAN Paediatric IBD Porto Group.

Because the patents for biopharmaceutical monoclonal antibodies have or soon will expire, biosimilars are coming to the market. This will most likely lead to decreased drug costs and so easier access to these expensive agents. Extrapolation, however, of the limited available clinical data from adults with rheumatologic diseases to children with inflammatory bowel disease (IBD) should be done with caution and needs some considerations.Postmarketing surveillance programs for efficacy, safety, and immunogenicity should become mandatory in children with IBD using biosimilars, as for all biological drugs.

Diagnóstico y tratamiento de la esofagitis eosinofílica en niños. Revisión de la literatura y recomendaciones basadas en la evidencia. Grupo de trabajo de la Sociedad Latinoamericana de Gastroenterología, Hepatología y Nutrición pediátrica (SLAGHNP).

During the last twenty years Eosinophilic Esophagitis has become one the most important causes of esophageal disfunction in children, food impactation in adolescents and young adults, therapeutic failure in patients with gastroesophageal reflux disease (GERD) and the most frecuent eosinophilic disease of the gastrointestinal tract. We present recommendations for the diagnosis and treatment of the disease based in a systematic review of the literature.

Do pediatricians apply the 2009 NASPGHAN-ESPGHAN guidelines for the diagnosis and management of gastroesophageal reflux after being trained?

BACKGROUND: According to a recent survey, the 2009 North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition-European Society for Pediatric Gastroenterology, Hepatology, and Nutrition gastroesophageal reflux guidelines are poorly adhered to by European primary care pediatricians. The main issue raised from the survey was the prescription of unnecessary acid suppressive medications, especially in infants. No inquiry into the reasons was made. The primary objective of the present study was to assess the applicability of the guidelines in European primary care pediatricians undergoing specific trainings. METHODS: One hundred pediatricians involved in the previous survey agreed to participate and were randomly divided into 2 groups: one group was trained in the guidelines through an online podcast and the other group was trained through a synopsis. During the following 3 months, each involved pediatrician was asked to enroll every consecutive infant, child, or adolescent with suggestive reflux symptoms. For every enrolled patient, pediatricians filled in a report concerning their diagnostic and therapeutic choices. RESULTS: A total of 382 patients (boys/girls 186/196, infants/children/adolescents 194/123/65) were enrolled by pediatricians. Infants with unexplained crying and/or distressed behavior who were prescribed proton-pump inhibitors were 3.7% compared with 45.2% of the survey data obtained before the training (P < 0.05). Infants with uncomplicated recurrent regurgitation and vomiting who were prescribed proton-pump inhibitors were 4.5% against 37.1% of the baseline survey data (P < 0.05). The overall rate of children managed in full compliance with the guidelines was 46.1% after the training compared with 1.8% before the training (P < 0.05). No significant differences were seen between pediatricians from podcast and synopsis group. CONCLUSIONS: The North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition-European Society for Pediatric Gastroenterology, Hepatology, and Nutrition gastroesophageal reflux guidelines have good applicability, despite that they are presently poorly adhered to by European primary care pediatricians. Simple, inexpensive trainings were proven to be effective in increasing adherence by pediatricians. The increase in compliance clearly favors the role of continuous medical education through simple educational tools and subsequent assessment of practice.

ESPGHAN revised porto criteria for the diagnosis of inflammatory bowel disease in children and adolescents.

BACKGROUND: The diagnosis of pediatric-onset inflammatory bowel disease (PIBD) can be challenging in choosing the most informative diagnostic tests and correctly classifying PIBD into its different subtypes. Recent advances in our understanding of the natural history and phenotype of PIBD, increasing availability of serological and fecal biomarkers, and the emergence of novel endoscopic and imaging technologies taken together have made the previous Porto criteria for the diagnosis of PIBD obsolete. METHODS: We aimed to revise the original Porto criteria using an evidence-based approach and consensus process to yield specific practice recommendations for the diagnosis of PIBD. These revised criteria are based on the Paris classification of PIBD and the original Porto criteria while incorporating novel data, such as for serum and fecal biomarkers. A consensus of at least 80% of participants was achieved for all recommendations and the summary algorithm. RESULTS: The revised criteria depart from existing criteria by defining 2 categories of ulcerative colitis (UC, typical and atypical); atypical phenotypes of UC should be treated as UC. A novel approach based on multiple criteria for diagnosing IBD-unclassified (IBD-U) is proposed. Specifically, these revised criteria recommend upper gastrointestinal endoscopy and ileocolonscopy for all suspected patients with PIBD, with small bowel imaging (unless typical UC after endoscopy and histology) by magnetic resonance enterography or wireless capsule endoscopy. CONCLUSIONS: These revised Porto criteria for the diagnosis of PIBD have been developed to meet present challenges and developments in PIBD and provide up-to-date guidelines for the definition and diagnosis of the IBD spectrum.

Pilot study on infant swimming classes and early motor development.

Alberta Infant Motor Scale (AIMS) scores were examined before and after four months of swimming classes in 12 babies (ages 7 to 9 mo.) assigned to Experimental (n = 6) and Control (n = 6) groups matched on age and developmental status. Infants from both groups improved their developmental status from pre- to post-test; the Experimental group improved on mean percentile rank. The sample size and the discriminative power of the AIMS do not allow conclusive judgments on these group differences, hence on the effect of infant swimming classes. Nevertheless, a number of recommendations are made for future studies on the effect of swimming classes on infant motor development.