ABSTRACT
OBJECTIVE: To evaluate whether the use of pictograms improves symptom evaluation for children with functional abdominal pain disorders (FAPDs). STUDY DESIGN: This survey study was conducted in 2 academic centers and included patients aged 8-18 years visiting the outpatient clinic for FAPD symptom evaluation. Patients were randomized to fill out the questionnaire without or with accompanying pictograms to assess gastrointestinal symptoms. Afterwards, patients underwent clinical health assessment by the healthcare professional (HCP). Subsequently, the HCP filled out the same questionnaire without pictograms, while blinded to the questionnaire completed by the patient. Primary outcome was the level of agreement between identified symptoms as assessed by patients and HCP. RESULTS: We included 144 children (questionnaire without accompanying pictograms [n = 82] and with accompanying pictograms [n = 62]). Overall agreements rates were not significantly different (without pictograms median, 70% vs with pictograms median, 70%). Accompanying pictograms did not significantly improve the assessment of abdominal pain symptoms. Accompanying pictograms were beneficial for concordance rates for nausea and vomiting symptoms (without pictograms median, 67% vs with pictograms median, 100%; P = .047). Subgroup analyses for children aged 8-12 years of age revealed similar results (concordance on the presence of nausea and vomiting without pictograms median, 67% vs with pictograms median, 100%; P = .015). Subgroup analyses for children ages 12-18 years showed no significant differences in concordance rates. CONCLUSIONS: Pictograms do not seem to improve the assessment of FAPDs. However, the use of pictograms improves the evaluation of nausea and vomiting, especially for children aged 8-12 years. Therefore, HCPs could consider using pictograms in that setting during consultations.
Subject(s)
Abdominal Pain , Gastrointestinal Diseases , Humans , Child , Abdominal Pain/diagnosis , Abdominal Pain/complications , Gastrointestinal Diseases/complications , Nausea , Vomiting , Health PersonnelABSTRACT
OBJECTIVE: To ensure consistency and reduce outcome measure reporting heterogeneity in clinical trials on pediatric functional abdominal pain disorders (FAPDs), a core outcome set (COS) was developed for pediatric FAPD trials. STUDY DESIGN: A mixed-method 2-round Delphi technique was used and key stakeholders, including healthcare professionals (HCPs), patients with FAPD, and their parents were invited to participate. In the first round, key stakeholders identified outcomes of importance through an open-ended questionnaire. Outcomes mentioned by ≥10% of the participants were included in a shortlist. In the second round, this shortlist was rated and prioritized. During a consensus meeting with an expert panel, the final COS was defined. RESULTS: The first round was completed by 152 of 210 (72%) HCPs, 103 (100%) parents, and 50 of 54 (93%) patients. A total of 104 from 167 (62%) HCPs, 102 (100%) parents, and 53 (100%) patients completed round 2. Pain intensity, pain frequency, quality of life, school attendance, anxiety/depression, adequate relief, defecation pattern (disease specific, irritable bowel syndrome), and adverse events were included in the final COS for FAPDs. CONCLUSION: A set of 8 core outcomes has been identified that should minimally be measured in pediatric FAPD trials. Implementation of the use of this COS will increase comparison between studies and, therefore, improve management of children with FAPDs.
Subject(s)
Abdominal Pain/therapy , Clinical Trials as Topic , Outcome Assessment, Health Care , Adolescent , Child , Child, Preschool , Delphi Technique , HumansABSTRACT
ABSTRACT Objective: This narrative review aimed to provide practitioners a synthesis of the current knowledge on the role of a low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet in reducing symptoms associated with functional abdominal pain disorders in children. This review is focused on the pathophysiology, efficacy and criticism of low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet in children. Sources: Cochrane Database, Pubmed and Embase were searched using specific terms for Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet interventions and functional abdominal pain disorders. Summary of the findings: In children, only one Randomized Control Trial and one open-label study reported positive results of low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet; one Randomized Control Trial showed exacerbation of symptoms with fructans in children with Irritable Bowel Syndrome; no effect was found for the lactose-free diet whilst fructose-restricted diets were effective in 5/6 studies. Conclusions: In children there are few trials evaluating low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols in functional abdominal pain disorders, with encouraging data on the therapeutic efficacy particularly of fructose-restricted diet. Additional efforts are still needed to fill this research gap and clarify the most efficient way for tailoring dietary restrictions based on the patient's tolerance and/or identification of potential biomarkers of low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols efficacy, to maintain nutritional adequacy and to simplify the adherence to diet by labeling Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols content in commercial products.
RESUMO Objetivo: Nos últimos anos, foram feitos esforços consideráveis para esclarecer o papel da dieta com baixo teor de oligossacarídeos fermentáveis, dissacarídeos, monossacarídeos e polióis (FODMAPs) para o tratamento de distúrbios gastrintestinais funcionais (DGIFs). Esta revisão narrativa teve como objetivo fornecer aos profissionais uma síntese do conhecimento atual sobre o papel de uma dieta com baixo teor de FODMAPs (BFM) na redução dos sintomas associados a distúrbios funcionais de dor abdominal (DFDA) em crianças. Esta revisão está focada na fisiopatologia, eficácia e crítica da dieta BFM em crianças. Fontes: O banco de dados Cochrane, Pubmed e Embase foram pesquisados com o uso dos termos específicos para intervenções na dieta FODMAP e DFDA. Resumo dos achados: Em crianças, apenas um estudo controlado randomizado e um estudo aberto relataram resultados positivos da dieta BFM; um estudo controlado randomizado mostrou exacerbação dos sintomas com frutanos em crianças com síndrome do intestino irritável; nenhum efeito foi encontrado para a dieta livre de lactose, enquanto dietas com restrição de frutose foram eficazes em 5/6 estudos. Conclusões: Existem poucos estudos que avaliam BFM em DFDA em crianças, com dados encorajadores sobre a eficácia terapêutica, particularmente de dietas com restrição de frutose. Esforços adicionais ainda são necessários para preencher essa lacuna de pesquisa e esclarecer a maneira mais eficiente de adaptar as restrições dietéticas com base na tolerância do paciente e/ou identificação de biomarcadores potenciais de eficácia da BFM, para manter a adequação nutricional e simplificar a adesão à dieta, ao incluir informações sobre conteúdo de FODMAPs em rótulos de produtos comerciais.
Subject(s)
Humans , Abdominal Pain/diet therapy , Diet, Carbohydrate-Restricted , Oligosaccharides/metabolism , Oligosaccharides/therapeutic use , Irritable Bowel Syndrome , Diet , Disaccharides/metabolism , Disaccharides/therapeutic use , Monosaccharides/metabolism , Monosaccharides/therapeutic useABSTRACT
OBJECTIVE: To systematically review definitions of functional abdominal pain orders (FAPDs) and outcome measures used in therapeutic randomized controlled trials in pediatric FAPDs adhering to the Outcome Measures in Rheumatology recommendations. STUDY DESIGN: Cochrane, MEDLINE, Embase, and Cinahl databases were systematically searched from inception to April 2018. English-written therapeutic randomized controlled trials concerning FAPDs in children aged 4-18 years were included. Definitions of FAPDs, interventions, outcome measures, measurement instruments, and outcome assessors of each study were tabulated descriptively. Quality was assessed using the Delphi List. RESULTS: A total of 4771 articles were found, of which 64 articles were included (n = 25, 39% of high methodologic quality). The Rome III (50%), Rome II (17%), Apley (16%), and author-defined (17%) criteria were used to define FAPDs. Fourteen studies (22%) assessed a pharmacologic, 25 (39%) a dietary, and 25 (39%) a psychosocial intervention. Forty-four studies (69%) predefined their primary outcomes. In total, 211 reported predefined outcome measures were grouped into 23 different outcome domains; the majority being patient-reported (n = 27, 61%). Of the 14 studies that evaluated a pharmacologic intervention, 12 (86%) reported on adverse events. CONCLUSIONS: Studies on pediatric FAPDs are of limited methodologic quality and show large heterogeneity and inconsistency in defining FAPDs and outcome measures used. Development of a core outcome set is needed to make comparison between intervention studies possible.
Subject(s)
Abdominal Pain/physiopathology , Abdominal Pain/psychology , Outcome Assessment, Health Care/statistics & numerical data , Adolescent , Child , Female , Humans , Male , Quality of Life , Randomized Controlled Trials as Topic , Severity of Illness IndexABSTRACT
OBJECTIVE: This narrative review aimed to provide practitioners a synthesis of the current knowledge on the role of a low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet in reducing symptoms associated with functional abdominal pain disorders in children. This review is focused on the pathophysiology, efficacy and criticism of low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet in children. SOURCES: Cochrane Database, Pubmed and Embase were searched using specific terms for Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet interventions and functional abdominal pain disorders. SUMMARY OF THE FINDINGS: In children, only one Randomized Control Trial and one open-label study reported positive results of low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols diet; one Randomized Control Trial showed exacerbation of symptoms with fructans in children with Irritable Bowel Syndrome; no effect was found for the lactose-free diet whilst fructose-restricted diets were effective in 5/6 studies. CONCLUSIONS: In children there are few trials evaluating low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols in functional abdominal pain disorders, with encouraging data on the therapeutic efficacy particularly of fructose-restricted diet. Additional efforts are still needed to fill this research gap and clarify the most efficient way for tailoring dietary restrictions based on the patient's tolerance and/or identification of potential biomarkers of low Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols efficacy, to maintain nutritional adequacy and to simplify the adherence to diet by labeling Fermentable Oligosaccharides Disaccharides Monosaccharides and Polyols content in commercial products.