Sophie Kuizenga-Wessel

Reporting on Outcome Measures of Functional Constipation in Children-A Systematic Review

Objective: Standardized outcome measures provide a basis for comparing outcomes of different clinical trials. Consequently, they can serve as the foundation for determining which therapeutic interventions are most effective. The aim of the present study is to systematically assess how definitions and outcome measures are defined in therapeutic randomized controlled trials (RCTs) of children with functional constipation (FC). Methods: PubMed, EMBASE, and Cochrane databases were searched. Studies were included if it was a (systematic review of) therapeutic RCT, concerning children from 1 to 18 years old with FC, a definition of FC was provided, and if they were written in English. The Delphi list was used for quality assessment. Results: A total of 4092 articles were found but only 45 studies fulfilled our inclusion criteria. In these 45 trials, 22 different definitions of FC were used (17 studies used the Rome III-criteria), 27 different interventions were investigated, and 29 different definitions of treatment success were used. Thirty RCTs (57%) reported primary outcomes of which treatment success was the most frequently used. Most trials (80%) used parental diaries of which only 2 RCTs stated that their instrument was validated. Twenty-four trials (53%) were of good methodological quality. Conclusions: Inconsistency and heterogeneity exist in definitions and outcome measures used in RCTs on childhood FC. Standard definitions, outcome measures, and also validated instruments are needed. We recommend the development of a minimum core outcome set for clinical research in children with FC to make comparison possible between the effects of different therapeutic interventions across studies.

Reporting outcome measures of functional constipation in children from 0 to 4 years of age.

ABSTRACT Functional constipation (FC) often begins in the first year of life. Although standard definitions and criteria have been formulated to describe FC, these are rarely used in research and clinical practice. The aim of the study is to systematically assess how definitions and outcome measures are defined in therapeutic randomized controlled trials (RCTs) of infants with FC. PubMed, EMBASE, and Cochrane databases were searched. Studies were included if it was a (systematic review of) therapeutic RCT, children ⩽4 years old, they had FC, a clear definition of constipation was provided, and were written in English. Quality was assessed using the Delphi list. A total of 1115 articles were found; only 5 studies fulfilled the inclusion criteria. Four different definitions were used, of which only 2 used the internationally accepted Rome III criteria. Defecation frequency was used as primary outcome in all included trials and stool consistency in 3 trials. Two trials involving infants investigated new infant formulas, whereas the third RCT evaluated the efficacy of a probiotic strain. The 2 trials including infants up to 4 years of age compared polyethylene glycol without electrolytes (PEG4000) with lactulose and milk of magnesia. All of the trials used nonvalidated parental diaries. Different definitions and outcome measures for FC in infants are used in RCTs. Disappointingly, there is a lack of well-designed therapeutic trials in infants with constipation. To make comparison between future trials possible, standard definitions, core outcomes, and validated instruments are needed.

Surgical decision-making in the management of children with intractable functional constipation: What are we doing and are we doing it right?

BACKGROUND Children with intractable functional constipation (FC) may eventually require surgery, often guided by motility testing. However, there are no evidence-based guidelines for the surgical management of intractable FC in children. AIM To assess the diagnostic and surgical approach of pediatric surgeons and pediatric gastroenterologists towards children with intractable FC. METHODS A survey was administered to physicians attending an international conference held simultaneously in Columbus (Ohio, USA) and Nijmegen (the Netherlands). The survey included 4 questions based on cases with anorectal and colonic manometry results. RESULTS 74 physicians completed the questionnaire. Anorectal manometry was used by 70%; 52% of them would consider anal sphincter botulinum toxin injections for anal achalasia and 21% would use this to treat dyssynergia. Colonic manometry was used by 38%; 57% of them reported to use this to guide surgical decision-making. The surgical approach varied considerably among responders answering the case questions based on motility test results; the most commonly chosen treatments were antegrade continence enemas and anal botulinum injections. CONCLUSION Surgical decision-making for children with intractable FC differs among physicians. There is a need for clinical guidelines regarding the role of anorectal and colonic manometry in surgical decision-making in children with intractable FC.

Transanal Irrigation in the Treatment of Children With Intractable Functional Constipation.

Objectives: The aim of the study was to assess the treatment efficacy of transanal irrigation and parental satisfaction in children with intractable functional constipation (FC) treated with Peristeen. Methods: Cross-sectional survey study among parents of children (age 0–18 years) treated with Peristeen for FC (based on the Rome III criteria). Anonymous questionnaires were sent out to parents via mail, these consisted of 25 self-developed, multiple-choice questions regarding the use of Peristeen, current gastrointestinal symptoms, adverse effects of Peristeen, concomitant medication use, and parental satisfaction. Results: Out of 91 invited families, 67 (74%) returned the questionnaire. In total, 84% of patients experienced fecal incontinence prior to treatment. Out of all children who still used Peristeen at the time of survey (n = 49), fecal incontinence had resolved completely in 41%, 12% experienced occasional episodes of fecal incontinence (<1 episode per week) and the remaining 47% still experienced episodes of fecal incontinence regularly (≥1 time per week). A total of 28 children (42%) experienced pain during rectal irrigation, especially during insertion of the catheter, inflating the balloon, or during irrigation. Overall, 86% of the parents were satisfied with the result of transanal irrigation and 67% reported that they would continue using transanal irrigation for the treatment of their childs symptoms. Conclusions: Transanal irrigation may be effective in the treatment of children with FC and renders a high parental satisfaction. Future prospective studies, preferably RCTs, are necessary to further evaluate this treatment option.

Surgical management of children with intractable functional constipation; experience of a single tertiary children's hospital

Children with intractable functional constipation (FC) may eventually require surgery. However, guidelines regarding the surgical management of children with intractable FC are lacking. The aim of this study was to describe the surgical management of FC in children.

Lack of Agreement on How to Use Antegrade Enemas in Children

Objectives: The aim of the present study was to provide an overview of the existing literature regarding the outcomes of the antegrade continence enema (ACE) procedure and to assess the present practices of physicians worldwide regarding the use of the ACE. Methods: A search of the MEDLINE database was performed using the following criteria: having a clear definition of “successful outcome,” published in full manuscript form, sample size >20 patients, age <25 years. We then conducted a survey among 23 pediatric gastroenterologists and surgeons worldwide who were known to use the ACE using an 18-item questionnaire. Results: A total of 21 articles met the inclusion criteria. Successful outcomes were reported in 15% to 100%. Thirteen studies classified the outcome as full continence (success) or incontinence (failure), with a mean successful outcome of 75.6%. The 23 physicians who completed the questionnaire differed in their opinions about indications and mandatory preoperative testing. Constipation with (78%) or without (91%) fecal incontinence, anorectal malformations (96%), and spinal abnormalities (100%) were considered suitable indications for the ACE by the majority. There was less agreement regarding the required preoperative diagnostic workup. Most physicians (70%) start infusions using saline solutions and do not add a stimulant laxative to the cleansing solution. Discussion: There is a wide variation in the reported outcome of the ACE procedure and in the way success is defined. The survey identifies important differences among physicians using the ACE. Consensus on optimal use of the ACE could improve outcome of this treatment option.

Development of a core outcome set for clinical trials in childhood constipation: a study using a Delphi technique

Objective Patients, their parents and healthcare professionals (HCPs) have a different perception regarding the symptoms of functional constipation (FC). Consequently, a lack of agreement exists on definitions and outcomes used in therapeutic trials of FC. Therefore, our aim was to develop a core outcome set (COS) for FC for children aged 0–1 year and 1–18 years. Design and setting Prospective study design: primary, secondary and tertiary care settings. Methods This COS was developed using a Delphi technique. First, HCPs, parents of children with FC and patients aged ≥12–18 years were asked to list up to five outcomes they considered relevant in the treatment of FC. Outcomes mentioned by >10% of participants were included in a shortlist. In the next phase, outcomes on this shortlist were rated and prioritised by HCPs, parents and patients. Outcomes with the highest scores were included in a draft COS. In a face-to-face expert meeting, the final COS was determined. Results The first phase was completed by 109 HCPs, 165 parents and 50 children. Fifty HCPs, 80 parents and 50 children completed the subsequent phase. The response rate was between 63% and 100% in both steps. The final COS for all ages consisted of: defecation frequency, stool consistency, painful defecation, quality of life, side effects of treatment, faecal incontinence, abdominal pain and school attendance. Conclusion The use of this COS for FC will decrease study heterogeneity and improve comparability of studies. Therefore, researchers are recommended to use this COS in future therapeutic trials on childhood FC.

Development of a Core Outcome Set for Clinical Trials in Childhood Constipation

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Functional Defecation Disorders and Excessive Body Weight: A Systematic Review.

CONTEXT: Several studies have suggested an association between functional defecation disorders (FDDs) and overweight/obesity in children. OBJECTIVE: To synthesize current evidence evaluating the association between FDDs and overweight/obesity in children. DATA SOURCES: PubMed, Medline, and Embase were searched from inception until January 25, 2016. STUDY SELECTION: Prospective and cross-sectional studies investigating the association between FDDs and overweight/obesity in children 0 to 18 years were included. DATA EXTRACTION: Data generation was performed independently by 2 authors and quality was assessed by using quality assessment tools from the National Heart, Lung, and Blood Institute. RESULTS: Eight studies were included: 2 studies evaluating the prevalence of FDDs in obese children, 3 studies evaluating the prevalence of overweight/obesity in children with FDDs, and 3 population-based studies. Both studies in obesity clinics revealed a higher prevalence of functional constipation (21%–23%) compared with the general population (3%–16%). In 3 case-control studies, the prevalence of overweight (12%–33%) and obesity (17%–20%) was found to be higher in FDD patients compared with controls (13%–23% and 0%–12%, respectively), this difference was significant in 2/3 studies. One of 3 population-based studies revealed evidence for an association between FDDs and overweight/obesity. Quality of 7/8 studies was rated fair or poor. LIMITATIONS: Due to heterogeneity of the study designs, we refrained from statistically pooling. CONCLUSIONS: Although several studies have revealed the potential association between FDDs and excessive bodyweight in children, results across included studies in this review differ strongly and are conflicting. Therefore, this systematic review could not confirm or refute this association.