HIV and STI positivity rates among transgender people attending two large STI clinics in the Netherlands.

BACKGROUND: Global data show that transgender people (TGP) are disproportionally affected by HIV and sexually transmitted infections (STIs); however, data are scarce for Western European countries. We assessed gender identities, sexual behaviour, HIV prevalence and STI positivity rates, and compared these outcomes between TGP who reported sex work and those who did not. METHODS: We retrospectively retrieved data from all TGP who were tested at the STI clinics of Amsterdam and The Hague, the Netherlands in 2017-2018. To identify one's gender identity, a 'two-step' methodology was used assessing, first, the assigned gender at birth (assigned male at birth (AMAB)) or assigned female at birth), and second, clients were asked to select one gender identity that currently applies: (1) transgender man/transgender woman, (2) man and woman, (3) neither man nor woman, (4) other and (5) not known yet. HIV prevalence, bacterial STI (chlamydia, gonorrhoea and/or infectious syphilis) positivity rates and sexual behaviour were studied using descriptive statistics. RESULTS: TGP reported all five categories of gender identities. In total 273 transgender people assigned male at birth (TGP-AMAB) (83.0%) and 56 transgender people assigned female at birth (TGP-AFAB) (17.0%) attended the STI clinics. Of TGP-AMAB, 14,6% (39/267, 95% CI 10.6% to 19.4%) were HIV-positive, including two new diagnoses and bacterial STI positivity was 15.0% (40/267, 95% CI 10.9% to 19.8%). Among TGP-AFAB, bacterial STI positivity was 5.6% (3/54, 95% CI 1.2% to 15.4%) and none were HIV-positive. Sex work in the past 6 months was reported by 53.3% (137/257, 95% CI 47.0% to 59.5%) of TGP-AMAB and 6.1% (3/49, 95% CI 1.3% to 16.9%) of TGP-AFAB. HIV prevalence did not differ between sex workers and non-sex workers. CONCLUSION: Of all TGP, the majority were TGP-AMAB of whom more than half engaged in sex work. HIV prevalence and STI positivity rates were substantial among TGP-AMAB and much lower among TGP-AFAB. Studies should be performed to provide insight into whether the larger population of TGP-AMAB and TGP-AFAB are at risk of HIV and STI.

Pharyngeal Chlamydia trachomatis in Men Who Have Sex With Men (MSM) in The Netherlands: A Large Retrospective Cohort Study.

Pharyngeal Chlamydia trachomatis (CT) was diagnosed in 1.2% and pharyngeal-only CT in 0.5% of routinely universally tested men who have sex with men (MSM). In these 3-anatomic-site tested MSM, pharyngeal-only CT comprised 4.8% of all CT. The low positivity of pharyngeal-only CT indicates low public health impact of pharyngeal CT.

Routine universal testing versus selective or incidental testing for oropharyngeal Chlamydia trachomatis in women in the Netherlands: a retrospective cohort study.

BACKGROUND: Pharyngeal Chlamydia trachomatis in women might contribute to autoinoculation and transmission to sexual partners. Data for effectiveness of different testing practices for pharyngeal C trachomatis are scarce. We therefore aimed to assess the prevalence of pharyngeal C trachomatis, determinants, and effectiveness of different testing practices in women. METHODS: We did a retrospective cohort study, in which surveillance data for all women visiting sexually transmitted infection clinics in all regions in the Netherlands between Jan 1, 2008, and Dec 31, 2017, were used. We collected consultation-level data and individual-level data from 2016 onwards for sociodemographic characteristics, sexual behaviour in the past 6 months, self-reported symptoms, and STI diagnoses. The primary outcome was the positivity rate of pharyngeal C trachomatis infection compared between routine universal testing (>85% tested pharyngeally per clinic year), selective testing (5-85% tested pharyngeally per clinic year), and incidental testing (<5% pharyngeally tested per clinic year). We calculated the number of missed infections by extrapolating the positivity rate assessed by routine universal testing to all selectively tested women. We used multivariable generalised estimating equations logistic regression analyses to assess independent risk factors for pharyngeal C trachomatis and used the assessed risk factors as testing indicators for comparing alternative testing scenarios. FINDINGS: Between Jan 1, 2008, and Dec 31, 2017, a total of 550 615 consultations with at least one C trachomatis test was recorded, of which 541 945 (98·4%) consultations (including repeat visits) were included in this analysis. Pharyngeal C trachomatis positivity was lower in the routine universal testing group than in the selective testing group (1081 [2·4%; 95% CI 2·2-2·5] of 45 774 vs 3473 [2·9%; 2·8-3·0] of 121 262; p<0·0001). The positivity rate was also higher among consultations done in the incidental testing group (44 [4·1%; 95% CI 3·1-5·5] of 1073; p<0·0001) than in the routine universal testing group. Based on extrapolation, selective testing would have hypothetically missed 64·4% (95% CI 63·5-65·3; 6363 of 9879) of the estimated total of C trachomatis infections. The proportion of pharyngeal-only C trachomatis was comparable between routinely universally tested women (22·9%) and selectively tested women (20·4%), resulting in a difference of 2·5% (95% CI -0·3 to 5·3; p=0·07). When using risk factors for pharyngeal C trachomatis as testing indicators, 15 484 (79·6%) of 19 459 women would be tested to detect 398 (80·6%) of 494 infections. INTERPRETATION: No optimal testing scenario was available for pharyngeal C trachomatis, in which only a selection of high-risk women needs to be tested to find most pharyngeal C trachomatis infections. The relative low prevalence of pharyngeal-only C trachomatis (0·5%) and probably limited clinical and public health effect do not provide support for routine universal testing. FUNDING: Public Health Service South Limburg.

High prevalence and resistance rates of Mycoplasma genitalium among patients visiting two sexually transmitted infection clinics in the Netherlands.

Mycoplasma genitalium is a well-known cause of urethritis in men and has been associated with cervicitis, pelvic inflammatory disease, and adverse obstetric outcomes in women. In this cross-sectional study, we determined the current prevalence of M. genitalium infection and the rate of macrolide resistance in M. genitalium isolates, in patients visiting two large Dutch sexually transmitted infection (STI) clinics, to evaluate whether the recommendations in Dutch guidelines should be revised. In addition, risk factors for M. genitalium were identified. In total, 3225 patients were included. M. genitalium prevalence rates were 13.8% for all patients; 20.1% for men who have sex with men, 8.2% for men who have sex with women, and 12.6% for women. Macrolide resistance-associated mutations were detected in 66% of the patients infected with M. genitalium. Age, educational level, country of origin, number of sexual partners, HIV-positivity, infection with Neisseria gonorrhoeae, and urethral symptoms in men were independently associated with M. genitalium infection. In conclusion, we found very high prevalence rates and macrolide resistance rates of M. genitalium in patients visiting STI clinics.

Routine universal testing versus selective or incidental testing for oropharyngeal Neisseria gonorrhoeae in women in the Netherlands: a retrospective cohort study.

BACKGROUND: Women are not routinely tested for oropharyngeal Neisseria gonorrhoeae. At present, selective testing based on sexual behaviour or risk groups is advocated by international guidelines. Many oropharyngeal infections are asymptomatic and thus remain undetected, establishing a reservoir for ongoing transmission. Data on effectiveness of routine testing are scarce, thus we aimed to assess the optimal testing strategy for oropharyngeal N gonorrhoeae in women. METHODS: In this retrospective cohort study, we used surveillance data obtained from all sexually transmitted infection (STI) clinics in the Netherlands between Jan 1, 2008, and Dec 31, 2017. We collected consultation-level data, and individual-level patient data from 2016 onwards, on sociodemographic characteristics, sexual behaviour in the past 6 months, self-reported symptoms, and STI diagnoses. We compared the prevalence of oropharyngeal N gonorrhoeae between women who attended clinics that offered routine universal testing (defined as >85% of women tested per clinic-year) and women who attended clinics that offered selective testing (defined as 5-85% of women tested per clinic-year) or incidental testing (<5% of women tested per clinic-year). We calculated the number of infections missed by selective testing by extrapolating prevalence for the routine universal testing group to that of weighted and unweighted samples of all selectively tested women. We used multivariable generalised estimating equations to identify independent risk factors for oropharyngeal N gonorrhoeae to identify the optimal selective testing strategy. FINDINGS: 554 266 consultations with at least one N gonorrhoeae test were recorded, of which 545 750 consultations (including repeat visits) were included in the analyses. Of 545 750 consultations, routine universal testing was used in 57 359 (10·5%), selective testing in 444 283 (81·4%), and incidental testing in 44 108 (8·1%). The prevalence of oropharyngeal N gonorrhoeae was 1·4% (95% CI 1·3-1·5; 703 of 50 962 consultations) in the routine testing group compared with 1·4% (1·3-1·5; 1858 of 132 276) in the selective testing group (p=0·68) and 2·8% (1·9-3·9; 30 of 1088) in the incidental testing group (p<0·0001). The prevalence of oropharyngeal-only infections was 47·7% (335 of 703 women) in the routine testing group, 53·3% (991 of 1858) in the selective testing group, and 60·0% (18 of 30) in the incidental testing group. Selective testing would have missed an estimated 4363 (70%; 95% CI 69-71) of all 6221 oropharyngeal N gonorrhoeae infections. Independent risk factors for oropharyngeal N gonorrhoeae were being notified for any STI (adjusted odds ratio 2·1, 95% CI 1·5-3·0), reporting sex work (4·0, 2·3-6·7), and having concurrent genital (51·5, 34·1-77·7) or anorectal (2·6, 1·4-4·8) N gonorrhoeae. Selective testing of women notified for any STI, or who reported sex work, would have led to 5418 (27·8%) of 19 455 women being tested and would have identified 119 (55·6%) of 214 oropharyngeal N gonorrhoeae infections. INTERPRETATION: Selective testing potentially misses more than two-thirds of oropharyngeal N gonorrhoeae infections in women, of whom half have oropharyngeal infections without concurrent genital or anorectal infections. Using independent risk factors for oropharyngeal infection to guide testing is a minimal testing strategy. Routine universal testing is the optimum scenario to detect the majority of infections. However, future studies are needed to assess the cost-effectiveness of routine testing and its effect on antimicrobial resistance. FUNDING: Public Health Service South Limburg.

Evaluating the prevalence and risk factors for macrolide resistance in Mycoplasma genitalium using a newly developed qPCR assay.

Mycoplasma genitalium (MG) is a sexually transmitted bacterium in which macrolide resistance is rapidly increasing, limiting treatment options. We validated a new assay to detect the presence of macrolide resistance-associated mutations in MG (MG-MRAM). In 2018, symptomatic and asymptomatic clients visiting sexually transmitted infections (STI) clinics in Amsterdam or The Hague were tested for MG using transcription mediated amplification (TMA) assays. The sensitivity to detect MG of the newly developed MG-MRAM qPCR was compared to the MgPa qPCR, both in relation to the TMA assay. For the sensitivity and specificity to detect relevant mutations the MG-MRAM qPCR was compared to 23SrRNA sequencing analysis. The qPCR was subsequently used to determine the presence of MG-MRAM at different anatomical locations and to identify risk factors for MG-MRAM. MG-positive clients (402) providing 493 MG-positive samples were included. In total 309/493 (62.7%) samples from 291 (72.4%) clients were successfully typed with the MG-MRAM qPCR. The MG-MRAM qPCR had a sensitivity of 98.6% (95%CI 91.1%-99.9%) and specificity of 94.1% (95%CI 78.9%-99.0%) to detect MG-MRAM compared to sequencing analysis. Infection with MG-MRAM was detected in 193/291 (66.3%) clients: in 129/178 (72.5%) men and 64/113 (56.6%) women (p = 0.005). Prevalence of MG-MRAM was significantly higher in men, clients with a higher education, HIV-positive clients and clients with >10 sexual partners in the previous six months, but in multivariable analysis no factor was significantly associated with MG-MRAM presence. Since MG-MRAM prevalence was very high, testing for MG-MRAM is essential if treatment for MG is considered, and can be performed with this sensitive and specific qPCR test in routine diagnostics.

What Is the Optimal Testing Strategy for Oropharyngeal Neisseria gonorrhoeae in Men Who Have Sex With Men? Comparing Selective Testing Versus Routine Universal Testing From Dutch Sexually Transmitted Infection Clinic Data (2008-2017).

BACKGROUND: Most oropharyngeal Neisseria gonorrhoeae infections are asymptomatic, and many infections remain undetected, creating a reservoir for ongoing transmission and potential drug resistance. It is unclear what the optimal testing policy is in men who have sex with men (MSM), as routine universal testing data are lacking. METHODS: Surveillance data from all Dutch sexually transmitted infection (STI) clinics between 2008 and 2017 were used (N = 271 242 consultations). Oropharyngeal testing policy was defined as routine universal testing when ≥85% of consultations included oropharyngeal testing or as selective testing (<85% tested). Independent risk factors for oropharyngeal N. gonorrhoeae were assessed among MSM routinely universally screened using backward multivariable logistic regression analyses. RESULTS: Routine universal testing was performed in 90% (238 619/265 127) of consultations. Prevalence was higher using routine universal testing (5.5%; 95% CI, 5.4-5.6; 12 769/233 476) than with selective testing (4.7%; 95% CI, 4.4-5.0; 799/17 079; P < .001). Proportions of oropharyngeal-only infections were 55% and 47%, respectively. Independent risk factors were age <31 years (OR, 2.1; 95% CI, 1.9-2.3), age 31-43 years (OR, 1.7; 95% CI, 1.6-1.9, compared with >43 years), being notified for any STI (OR, 2.0; 95% CI, 1.9-2.1), concurrent urogenital N. gonorrhoeae (OR, 2.4; 95% CI, 2.1-2.7), and concurrent anorectal N. gonorrhoeae (OR, 11.4; 95% CI, 10.6-12.3). When using any of the risk factors age, notified, or oral sex as testing indicators, 98.4% (81 022/82 332) of MSM would be tested, finding 99.5% (4814/4838) of infections. CONCLUSIONS: Routine universal testing detected more oropharyngeal N. gonorrhoeae infections than selective testing, of which more than half would be oropharyngeal only. Using independent risk factors as testing indicator is not specific. Therefore, routine universal oropharyngeal testing in MSM is feasible and warranted, as currently advised in most guidelines.

Attention Deficit Hyperactivity Disorder and Functional Defecation Disorders in Children.

OBJECTIVES: The aim of the study was to assess the prevalence of attention deficit hyperactivity disorder (ADHD) in children presenting with functional defecation disorders (FDDs) and to assess the prevalence of FDDs in children with ADHD. METHODS: A cross-sectional cohort study was carried out between September 2014 and May 2016. Group 1: Parents of children with FDDs according to the Rome III criteria completed the Child Behavior Checklist and the VvGK (Dutch questionnaire based on the American Disruptive Behavior Disorder rating scale). Patients with ADHD subarea scores ≥70 on the Child Behavior Checklist and/or ≥16 on the VvGK were referred for further psychiatric evaluation. Group 2: Parents of children treated for ADHD at a specialized ADHD outpatient clinic completed a standardized questionnaire regarding their child's defecation pattern. RESULTS: In group 1 (282 children with FDDs), 10.3% (7.1%-13.5% bias-corrected and accelerate confidence interval) were diagnosed with ADHD. Group 2 consisted of 198 children with ADHD, 22.7% (17.6-28.8 bias-corrected and accelerate confidence interval) fulfilled the Rome III criteria for an FDD. Children with both an FDD and ADHD reported urinary incontinence significantly more often compared to children with an FDD or ADHD alone: 57.1% in FDD + ADHD versus 22.8% in FDD alone (P < 0.001) and 31.1% in ADHD + FDD versus 7.8% in ADHD alone (P < 0.001). CONCLUSIONS: Approximately 10.3% of children with FDDs had ADHD and 22.7% of children with a known diagnosis of ADHD fulfilled the Rome III criteria for an FDD. This observation suggests that screening for behavioral disorders and FDDs should be incorporated into the diagnostic workup of these groups of children.

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 child's 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.

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.

Screening for autism identifies behavioral disorders in children functional defecation disorders.

UNLABELLED: This study prospectively assessed whether positive screening surveys for autism spectrum disorders (ASDs) in children with functional defecation disorders (FDDs) accurately identify ASD. Parents of children (4-12 years) who met Rome III criteria for functional constipation (FC), FC with fecal incontinence (FI) and functional nonretentive FI (FNRFI) completed two ASD screening surveys. Children with positive screens were referred for psychological evaluation, and a year later, follow-up surveys were conducted. Of the 97 study participants, 30.9 % were diagnosed with FC, 62.9 % with FC with FI, and 6.2 % with FNRFI. ASD surveys were positive for 27 children (27.8 %). New DSM diagnoses were made in 10 out of the 15 children that completed further evaluation. Two (2.1 %) met criteria for ASD, and 12 (12.4 %) met criteria for other behavioral disorders. Average SRS and SCQ-L scores were higher in subjects with FC with FI as compared to FC alone and in those who reported no improvement versus those who reported improvement 1 year later. CONCLUSION: While positive ASD screening surveys did not correctly identify ASD in the majority, it did help to identify other unrecognized behavioral disorders in children with FDD. High screening scores were more common in children with FC with FI and in children with poorer responses to current medical treatments. WHAT IS KNOWN: •A prior study found that 29 % of children with FDD scored positive on ASD screening questionnaires. •Whether positive screens correctly identify ASD in children with FDD is unknown. What is New: •This study shows that positive ASD screens do not correctly identify ASD in children with FDD. However, the use of ASD screening questionnaires can identify previously unrecognized and untreated behavioral/developmental disorders in children with FDD. •High screening scores are more common in children with FC with FI and in children with poorer responses to current medical treatments.

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.

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.

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.

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.

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

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.