Complication rates of dilation and evacuation and labor induction in second-trimester abortion for fetal indications: A retrospective cohort study.

OBJECTIVE: To compare complication rates of dilation and evacuation (D&E) to mifepristone and misoprostol labor induction for second trimester abortion for fetal indications. STUDY DESIGN: We performed a retrospective cohort study comparing complication rates with D&E and labor induction abortion for fetal indications at 14 weeks 0 days through 23 weeks and 6 days gestation between January 1, 2009, and August 31, 2017. We extracted demographic, procedural, and outcome data, focusing specifically on complications of maternal hemorrhage, infection, emergency department visit, hospital readmission, retained tissue requiring dilation and curettage (D&C), manual placental removal, or thromboembolism. We compared complication rates between the D&E and induction groups using univariate and multivariate analyses. RESULTS: We included outcomes from 75 (48%) D&E and 81 (52%) labor induction abortions. We identified any complication in 1 (1%) and 7 (7%) of patients, respectively (p = 0.12). The only complication in the D&E group was hemorrhage with an estimated blood loss of 1000 mL not requiring transfusion. Labor induction complications included retained tissue requiring manual removal (n = 2) or D&C (n = 1) and hemorrhage (n = 2). CONCLUSION: There was no difference in complication rates between the D&E group and the labor induction group. IMPLICATIONS: This study compared outcomes between D&E and labor induction using mifepristone and misoprostol for second trimester abortion. Our complication rate for labor induction using mifepristone and misoprostol, and particularly our rate of retained placenta requiring D&C, was lower than what has been previously reported for second trimester labor induction termination using other methods. This study suggests there is a benefit for the routine use of mifepristone with misoprostol for second trimester labor induction. Additionally, the low rate of major complications in this study for both D&E and labor induction further validates the safety of both procedures for second trimester abortion.

Cardiac Magnetic Resonance Imaging (MRI) in Children is Safe with Most Pacemaker Systems, Including Those with Epicardial Leads.

Magnetic resonance imaging (MRI) of patients with pacemakers remains concerning because of possible magnetic field effects on the device. Many pacemaker models are labeled as non-conditional, or contraindicated for MRI, or do not have any specific safety guidelines listed. This study describes our experience with pacemaker function and adverse events in pediatric and young adult patients after clinically indicated MRI scanning at 1.5 Tesla (T). We hypothesized that generator battery voltage, pacemaker lead threshold, and lead impedance would not be altered by MRI. This was a retrospective review of Children's Wisconsin clinical MRI data for all patients with pacemakers scanned between January 1, 2010 and March 31, 2018. Pacemakers were interrogated by the Electrophysiology Team before and immediately after MRI and at outpatient follow up. Twenty-one patients underwent forty-four MRI scans. No significant immediate changes were seen in any pacemaker parameter for any manufacturer/model/lead at the time of MRI. At first clinical follow up post MRI, (median 4.4 months, range 0.2-12.3), battery voltage was reduced (2.78 V pre-MRI versus 2.77 V at follow up, p = 0.02), but there were no other significant changes. No adverse events were noted. Pediatric patients with pacemakers, including those with epicardial leads, can be scanned at 1.5 T safely without alteration in pacemaker function. Using appropriate precautions, pediatric patients with pacemakers can be imaged with MRI.

Comparing mental health disorders among sex trafficked children and three groups of youth at high-risk for trafficking: A dual retrospective cohort and scoping review.

BACKGROUND: Individuals at high-risk for trafficking are often subject to preexisting complex trauma that only intensifies during the trafficking experience. This greatly increases their risk of mental illness, although the actual prevalence of mental health disorders in children who are sex trafficked remains unclear. OBJECTIVE: To examine the prevalence of mental health diagnoses among a sample of youth identified as being sex trafficked, and to discuss these rates in relation to other high-risk groups reported in the literature. PARTICIPANTS AND SETTING: 143 female and male child trafficking victims in Wisconsin. METHODS: We retrospectively reviewed individual medical records, identifying mental health diagnoses and behaviors. The results were compared to summarized prevalence data for mental health disorders in sex trafficked, runaway children, juvenile offenders, and foster care children identified via a scoping review. RESULTS: We observed significantly higher rates of ADHD (52.4%, p < 0.0001), bipolar disorder (26.6%, p < 0.0001), and PTSD (19.6%, p < 0.05 to p < 0.0001) in our sample of trafficked youth compared to all high-risk groups, as well as for depression (45.5%), anxiety (19.6%), conduct disorder (19.6%), ODD (25.9%), and psychosis (14.0%) relative to multiple groups individually. CONCLUSIONS: The complex trauma suffered by child survivors of sex trafficking can impart numerous effects with overlapping symptomatology of many mental health disorders. Survivors' adaptive responses to complex trauma may lead to improper diagnosis and treatment of mental health disorders at the expense of prompt access to trauma-focused therapies. Alternative diagnoses and treatments of this complex dysfunction are discussed.

Efficacy of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial.

BACKGROUND & AIMS: Auricular neurostimulation therapy, in which a noninvasive device delivers percutaneous electrical nerve field stimulation (PENFS) to the external ear, is effective in pediatric patients with functional abdominal pain disorders. Preclinical studies showed that PENFS modulates central pain pathways and attenuates visceral hyperalgesia. We evaluated the efficacy of PENFS in adolescents with irritable bowel syndrome (IBS). METHODS: We analyzed data from pediatric patients with IBS who participated in a double-blind trial at a tertiary care gastroenterology clinic from June 2015 through November 2016. Patients were randomly assigned to groups that received PENFS (n = 27; median age, 15.3 y; 24 female) or a sham stimulation (n = 23; median age, 15.6 y; 21 female), 5 days/week for 4 weeks. The primary endpoint was number of patients with a reduction of 30% or more in worst abdominal pain severity after 3 weeks. Secondary endpoints were reduction in composite abdominal pain severity score, reduction in usual abdominal pain severity, and improvement in global symptom based on a symptom response scale (-7 to +7; 0 = no change) after 3 weeks. RESULTS: Reductions of 30% or more in worst abdominal pain were observed in 59% of patients who received PENFS vs 26% of patients who received the sham stimulation (P = .024). The patients who received PENFS had a composite pain median score of 7.5 (interquartile range [IQR], 3.6-14.4) vs 14.4 for the sham group (IQR, 4.5-39.2) (P = .026) and a usual pain median score of 3.0 (IQR, 3.0-5.0) vs 5.0 in the sham group (IQR, 3.0-7.0) (P = .029). A symptom response scale score of 2 or more was observed in 82% of patients who received PENFS vs 26% of patients in the sham group (P ≤ .001). No significant side effects were reported. CONCLUSIONS: Auricular neurostimulation reduces abdominal pain scores and improves overall wellbeing in adolescents with IBS. PENFS is a noninvasive treatment option for pediatric patients with functional bowel disorders. ClinicalTrials.gov no: NCT02367729.

Single-center experience suggests donor lymphocyte infusion may promote long-term survival in children with high-risk acute lymphoblastic leukemia.

BACKGROUND: Donor lymphocyte infusion (DLI) is often used to treat leukemic relapse after hematopoietic cell transplantation (HCT). However, the relationship between outcomes and distinct DLI cellular composition has not been previously reported. Additionally, there are limited published data on efficacy in pediatrics. We evaluated whether DLI cellular content and development of graft-versus-host disease (GVHD) impacted disease and influenced overall survival (OS) in children receiving DLI for recurrent leukemia. METHODS: We performed an Institutional Review Board-approved, retrospective study investigating all consecutive DLIs given to patients at the Children's Hospital of Wisconsin between 1980 and 2018. Analyses were conducted using Mann-Whitney, Fisher exact, and chi-square tests. RESULTS: Thirty patients ≤20 years old with hematologic malignancies (myeloid [AML/MDS/CML/JMML], n = 23; lymphoid [ALL], n = 7) received DLI to treat post-transplant relapse. We found no significant difference in OS or development of GVHD based on CD3, CD4, CD8, CD56, or CD19 DLI cellular composition. With a median follow-up of 0.69 (range, 0.04-16.61) years, OS at five years was 32% ± 9%.  The lymphoid group had a five-year survival rate at 71% ± 17% compared with the myeloid group at 22% ± 9%, although not statistically significant (P = 0.11).  The development of GVHD did not affect OS (P = 0.62). CONCLUSION: Here, we report a single-center, long-term experience of pediatric DLIs. Surprisingly, many children with ALL were able to achieve durable remissions. Although cellular composition did not have a significant effect on GVHD or OS in our small study, engineering DLI products to maximize specific effector cell populations could be one strategy to improve efficacy.

Adolescent Inpatients With Eating Disorders: Comparison Between Acute and Chronic Malnutrition States on a Refeeding Protocol.

This study is a comparison of eating disorder patient outcomes on similar nutrition regimens regardless of degree of malnutrition. Acuity of symptoms in chronically and acutely malnourished patients were analyzed to determine the influence the duration of malnutrition has on refeeding syndrome. Patient outcomes did not differ based on chronicity of malnutrition and are compatible with previous studies in terms of weight gain, medical stabilization, and rate of electrolyte imbalance.

Nausea exacerbates symptom burden, quality of life, and functioning in adolescents with functional abdominal pain disorders.

BACKGROUND: Nausea frequently co-exists with functional abdominal pain disorders (FAPDs) and may be linked to a higher disease burden. This study aimed to prospectively compare multisystem symptoms, quality of life, and functioning in FAPDs with and without nausea. METHODS: Adolescents ages 11-18 years fulfilling Rome III criteria for a FAPD were grouped by the presence or absence of chronic nausea. Subjects completed validated instruments assessing nausea (Nausea Profile Questionnaire = NPQ), quality of life (Patient-Reported Outcome Measurement Information System), functioning (Functional Disability Inventory), and anxiety (State-Trait Anxiety Inventory for Children). Group comparisons were performed for instruments, multisystem symptoms, school absences, and clinical diagnoses. KEY RESULTS: A total of 112 subjects were included; 71% reported chronic nausea. Patients with Nausea compared to No Nausea had higher NPQ scores (P ≤ 0.001), worse quality of life (P = 0.004), and greater disability (P = 0.02). State and trait anxiety scores were similar (P = 0.57, P = 0.25). A higher NPQ score correlated with poorer quality of life, more disability, and higher anxiety. Specific comorbidities were more common in Nausea vs No Nausea group: dizziness (81% vs 41%; P ≤ 0.001), concentrating difficulties (68% vs 27%; P ≤ 0.001), chronic fatigue (58% vs 20%; P = 0.01), and sleep disturbances (73% vs 48%; P = 0.02). The Nausea group reported more school absences (P = 0.001) and more commonly met criteria for functional dyspepsia (P = 0.034). CONCLUSION AND INFERENCES: Nausea co-existing with FAPDs is associated with a higher extra-intestinal symptom burden, worse quality of life, and impaired functioning in children. Assessing and targeting nausea therapeutically is essential to improve outcomes in FAPDs.

Ancillary Benefit of Increased HPV Immunization Rates Following a CBPR Approach to Address Immunization Disparities in Younger Siblings.

Increasing HPV vaccination rates may decrease the disproportionately high HPV-associated disease incidence and mortality in African Americans (AA) and lower socioeconomic individuals. Data from a community-based participatory research (CBPR) study addressing immunization disparities among 19-35 month old children was analyzed to identify ancillary benefits in HPV immunization rates for adolescent siblings. Sub-study analysis inclusion criteria: AA (N = 118), 13-17 years old, younger sibling enrolled in parent study, and enrolled ≥ 9 months. Parent/caregiver interventions included: a web-based immunization toolkit with information on age-appropriate vaccines; a multimedia community outreach campaign; and reminder mailings. HPV up-to-date (UTD) status was defined as Wisconsin Immunization Registry (WIR) documentation of at least three HPV vaccines. McNemar's test compared pre/post intervention HPV status. Two dependent proportions testing compared the proportion of adolescents that became UTD in the study cohort, City of Milwaukee, and State of Wisconsin. Parents/caregivers perceived that 92% of adolescents were HPV-UTD, while only 24% had a WIR-verified HPV-UTD status. Baseline UTD status of the younger siblings 19-35 month old 4:3:1:3:3:1:4 antigen series was 63%, which increased to 86% at study completion. Adolescent's HPV-UTD immunization status increased from 30 (25%) at enrollment to 54 (46%) at study completion [p = 0.004]. A statistically significant larger proportion of adolescents became HPV-UTD in the study cohort (20%) compared to the City of Milwaukee [14%, p = 0.042] and the State of Wisconsin [14%, p = 0.046]. A culturally-tailored CBPR approach targeting parents/caregivers of younger AA children can have significant ancillary benefit to increase HPV immunization rates in adolescent siblings.

Occult drug exposure in young children evaluated for physical abuse: An opportunity for intervention.

BACKGROUND: Although screening for drug exposure is an important consideration in the evaluation of suspected child maltreatment, limited data are available on the frequency of drug exposure in children with suspected physical abuse. OBJECTIVE: To examine occult drug and pharmaceutical exposure in young children with suspected physical abuse. PARTICIPANTS AND SETTING: Children ages 2 weeks -59 months evaluated for physical abuse by a tertiary referral center Child Protection Team. METHODS: Cross-sectional study of young children diagnosed with high, intermediate, or low concern for physical abuse and tested for occult drug exposure from 2013-2017. Chart review was performed to determine adherence to recommended testing and drug test results with comparison between groups. RESULTS: Occult drug exposures were found in 5.1% (CI 3.6-7.8) of 453 children tested: 6.0% (CI 3.6-10.0) of 232 children with high concern for physical abuse, 5.0% (CI 2.7-9.3) of 179 children with intermediate concern, and 0% of 42 children with low concern. As adherence to protocol-based screening improved during the second half of the study, so did the overall rate of detection of occult drug exposures (7.9%, CI 5.2-11.9) in 252 children with intermediate or high concern for physical abuse. Most exposures were to cocaine, although non-prescribed pharmaceutical exposures were also detected. CONCLUSIONS: Up to 7.9% of young children suspected of being physically abused also had an occult drug exposure. Given the adverse health consequences associated with exposure to a drug-endangered environment, screening for occult drug exposure should be considered in the evaluation of young children with intermediate or high concern for physical abuse.

Life-Threatening Allergies: Using a Patient-Engaged Approach.

BACKGROUND: Adolescents at risk for anaphylaxis are a growing concern. Novel training methods are needed to better prepare individuals to manage anaphylaxis in the community. INTRODUCTION: Didactic training as the sole method of anaphylaxis education has been shown to be ineffective. We developed a smartphone-based interactive teaching tool with decision support and epinephrine auto-injector (EAI) training to provide education accessible beyond the clinic. METHODS: This study consisted of two parts: (1) Use of food allergy scenarios to assess the decision support's ability to improve allergic reaction management knowledge. (2) An assessment of our EAI training module on participant's ability to correctly demonstrate the use of an EAI by comparing it to label instructions. RESULTS: Twenty-two adolescents were recruited. The median (range) baseline number of correct answers on the scenarios before the intervention was 9 (3-11). All subjects improved with decision support, increasing to 11 (9-12) (p < .001). The median (range) demonstration score was 6 (5-6) for the video training module group and 4.5 (3-6) for the label group (p < 0.001). DISCUSSION: Results suggest that the use of this novel m-health application can improve anaphylaxis symptom recognition and increase the likelihood of choosing the appropriate treatment. In addition, performing EAI steps in conjunction with the video training resulted in more accurate medication delivery with fewer missed steps compared to the use of written instructions alone. CONCLUSION: The results suggest that mobile health decision support technology for anaphylaxis emergency preparedness may support traditional methods of training by providing improved access to anaphylaxis training in the community setting.

Identification of molecular signatures of cystic fibrosis disease status with plasma-based functional genomics.

Although cystic fibrosis (CF) is attributed to dysfunction of a single gene, the relationships between the abnormal gene product and the development of inflammation and progression of lung disease are not fully understood, which limits our ability to predict an individual patient's clinical course and treatment response. To better understand CF progression, we characterized the molecular signatures of CF disease status with plasma-based functional genomics. Peripheral blood mononuclear cells (PBMCs) from healthy donors were cultured with plasma samples from CF patients ( n = 103) and unrelated, healthy controls ( n = 31). Gene expression levels were measured with an Affymetrix microarray (GeneChip Human Genome U133 Plus 2.0). Peripheral blood samples from a subset of the CF patients ( n = 40) were immunophenotyped by flow cytometry, and the data were compared with historical data for age-matched healthy controls ( n = 351). Plasma samples from another subset of CF patients ( n = 56) and healthy controls ( n = 16) were analyzed by multiplex enzyme-linked immunosorbent assay (ELISA) for numerous cytokines and chemokines. Principal component analysis and hierarchical clustering of induced transcriptional data revealed disease-specific plasma-induced PBMC profiles. Among 1,094 differentially expressed probe sets, 51 genes were associated with pancreatic sufficient status, and 224 genes were associated with infection with Pseudomonas aeruginosa. The flow cytometry and ELISA data confirmed that various immune modulators are relevant contributors to the CF molecular signature. This study provides strong evidence for distinct molecular signatures among CF patients. An understanding of these molecular signatures may lead to unique molecular markers that will enable more personalized prognoses, individualized treatment plans, and rapid monitoring of treatment response.

Children and adolescents with sickle cell disease have worse cold and mechanical hypersensitivity during acute painful events.

Sickle cell disease (SCD) pain associates with cold temperature and touch. Patients and murine models with SCD have baseline thermal and mechanical pain. In SCD mice, the baseline hypersensitivity is exacerbated by experimental vaso-occlusive crises. We hypothesized that patients with SCD will similarly experience increased hypersensitivity to thermal and mechanical stimuli during acute painful events compared with baseline health. We conducted a prospective study of 24 patients with SCD aged 7 to 19 years. Patients underwent quantitative sensory testing to thermal (cold/heat) and mechanical stimuli on the thenar eminence of the nondominant hand (glabrous skin) and the lateral dorsum of the foot (hairy skin) during baseline health and within 48 hours of hospitalization for acute pain. Primary outcomes were changes in: (1) cold pain threshold (°C), (2) heat pain threshold (°C), and (3) mechanical pain threshold (g). Median age was 10.5 (interquartile range [IQR] 9-14.8) years, 67% were females, and 92% were on hydroxyurea. Patients with SCD had increased cold pain sensitivity in the hand during hospitalization compared with baseline (25.2°C [IQR 18.4-27.5°C] vs 21.3°C [IQR 4.9-26.2°C]; P = 0.011) and increased mechanical pain sensitivity in the foot during hospitalization (0.32 g [IQR 0.09-1.1 g] vs 1.7 g [IQR 0.4-8.3 g]; P = 0.003). There were no differences in heat pain sensitivity. The increased cold (P = 0.02) and mechanical (P = 0.0016) pain sensitivity during hospitalization persisted after adjusting for age, sex, hydroxyurea use, opioid consumption, and numeric pain score. Thus, cold and mechanical pain is significantly worse during an acute SCD painful event as compared to baseline health in patients with SCD.

Clinical course and significance of nontuberculous mycobacteria and its subtypes in cystic fibrosis.

BACKGROUND: Nontuberculous mycobacteria (NTM) infections in patients with cystic fibrosis (CF) is increasing globally. However, the related epidemiology, comorbidities, and clinical impact of NTM infection remains unclear in the progress of CF lung disease and patient survival. METHODS: We performed a retrospective, case-control, cohort study (10 years), comparing NTM culture-positive CF patients (N = 28) to matched controls (N = 26). NTM positive patients were divided in to two groups of slow-growing (N = 17) and rapid- growing NTM (N = 8). Three patients were positive for both slow and rapid NTM. For independent group comparisons, a non-parametric Mann-Whitney test (Kruskal-Wallis test for more than two groups) was used to compare the continuous variables, and a Fisher's exact test was used for the categorical variables. Paired comparisons were performed using a Wilcoxon signed-rank test. RESULTS: The prevalence of NTM isolation was 8%. The age at CF diagnosis was significantly lower in the slow-growing NTM group compared to the rapidly growing NTM group (P = 0.04). The median percent predicted forced expiratory flow of 25% - 75% (FEF25-75) was significantly higher before NTM acquisition in slow-growing (P = 0.013) and rapidly growing NTM group (P = 0.028). The slow-growing NTM group received significantly more penicillin/beta lactamase (P = 0.010) and rifampin (P = 0.042) following isolation. Macrolide use was significantly higher after isolation in both the slow-growing NTM (P = 0.018) and rapidly growing NTM groups (P = 0.042). CONCLUSIONS: An earlier CF diagnosis was associated with a higher isolation of slow-growing NTM and greater antimicrobial use after infection. NTM acquisition is associated with a worsening of FEF25-75. Thus, both the early diagnosis and treatment of an NTM infection in patients with CF may positively impact lung function.

Cardiopulmonary Exercise Testing for Surgical Risk Stratification in Adults with Congenital Heart Disease.

Adult congenital heart disease (ACHD) patients often require repeat cardiothoracic surgery, which may result in significant morbidity and mortality. Currently, there are few pre-operative risk assessment tools available. In the general adult population, pre-operative cardiopulmonary exercise testing (CPET) has a predictive value for post-operative morbidity and mortality following major non-cardiac surgery. The utility of CPET for risk assessment in ACHD patients requiring cardiothoracic surgery has not been evaluated. Retrospective chart review was conducted on 75 ACHD patients who underwent CPET less than 12 months prior to major cardiothoracic surgery at Children's Hospital of Wisconsin. Minimally invasive procedures, cardiomyopathy, acquired heart disease, single ventricle physiology, and heart transplant patients were excluded. Demographic information, CPET results, and peri-operative surgical data were collected. The study population was 56% male with a median age of 25 years (17-58). Prolonged post-operative length of stay correlated with increased ventilatory efficiency slope (VE/[Formula: see text] slope) (P = 0.007). Prolonged intubation time correlated with decreased peak HR (P = 0.008), decreased exercise time (P = 0.002), decreased heart rate response (P = 0.008) and decreased relative peak oxygen consumption (P = 0.034). Post-operative complications were documented in 59% of patients. While trends were noted between post-operative complications and some measurements of exercise capacity, none met statistical significance. Future studies may further define the relationship between exercise capacity and post-operative morbidity in ACHD patients.

Implementation of a quality improvement project for universal genetic testing in women with ovarian cancer.

OBJECTIVE: The National Comprehensive Cancer Network recommends all women with ovarian cancer be offered genetic testing. Despite a decade of endorsement, many oncology practitioners have yet to make this a part of routine practice. Referral to genetic counseling and completion of genetic testing among patients at substantial risk of germline mutations are significantly lacking, adversely affecting patient care and squandering an opportunity to maximize cancer prevention efforts. This project determined the impact and feasibility of implementing a basic model for universal referral to genetic counseling and completion of genetic testing in women with a diagnosis of ovarian cancer in an academic gynecology oncology practice with access to electronic health records (EHRs). METHODS: Patients diagnosed with ovarian cancer from January 2008 to November 2013 were retrospectively reviewed to determine the baseline referral rate for genetic counseling and testing completion in our practice. Implementation of a process change model combining provider training, patient education, enhanced electronic health record documentation and improved patient appointment scheduling strategies were implemented. We then prospectively collected data on all newly diagnosed ovarian cancer patients that had not already undergone genetic testing presenting from December 1, 2013 to November 30, 2016. RESULTS: Genetic referral rates, genetic counseling and testing completion rates were markedly improved. Pre-implementation our genetic testing rate was 27% and post implementation our testing rate was 82% (p-value≤0.001). CONCLUSIONS: Low cost interventions that target education of both providers and patients regarding the importance of genetic testing along with utilization of the EHR and streamlined patient appointment services can significantly increase rates of genetic testing completion.

Safety of peripherally inserted central catheters during pregnancy: a retrospective study.

PURPOSE: We investigated the incidence of complications associated with peripherally inserted central line catheters, inserted using a standardized technique, during pregnancy and the postpartum period. MATERIALS AND METHODS: A retrospective case series was performed that included all pregnant and postpartum women who received peripherally inserted central catheters (PICCs) at a single institution between 2006 and 2014. Patient demographics and data on infectious, mechanical and thrombotic complications were collected. Some patients required more than one line insertion during the same pregnancy. In these instances, only the first line placement for each subject was included in the analysis of complications. RESULTS: One hundred and forty-six catheters were inserted in 112 pregnant and postpartum patients. The total incidence of complications was 17% (19/112). Specific complications included infection (n = 4, 3.6%), mechanical (n = 5, 4.4%), deep venous thrombosis (n = 2, 1.8%) and other (n = 8, 7.1%). Demographics of the complication and no complication groups were similar. CONCLUSIONS: In contrast with previous studies, we report a complication rate associated with peripheral line use in pregnant and postpartum women that appears similar to that in non-pregnant populations.

Outcomes after fecal diversion for colonic and perianal Crohn disease in children.

BACKGROUND: Temporary fecal diversion by means of an ileostomy or colostomy has been used in the surgical management of refractory colonic and perianal Crohn disease (CD). The aims of our study were to evaluate the outcomes after fecal diversion in pediatric patients with colonic and perianal CD. METHODS: The records of patients who underwent fecal diversion for colonic and perianal CD at Children's Hospital of Wisconsin between July 2000 and June 2014 were reviewed retrospectively. Patient demographics, medication use, onset and extent of disease, response to fecal diversion, rate of stoma reversal and relapse rate after stoma reversal were recorded. RESULTS: We identified 28 consecutive patients (20 females, 8 males; median age 13.9years) undergoing fecal diversion for refractory colonic (n=21) and perianal CD (n=7). Median duration of follow-up after fecal diversion was 2.26years (range, 0.79-10.2years). The response to fecal diversion was sustained clinical remission in 13/28 (46%), temporary clinical remission in 10/28 (36%), no change in 5/28 (18%). Intestinal continuity was restored in 14/28 (50%) patients; however, 3 (21%) required permanent stoma after reconnection. Classification tree analysis identified that female patients without perianal CD had higher rates of stoma reversal (p=0.008). CONCLUSIONS: Fecal diversion can induce remission in pediatric patients with refractory colonic and perianal CD. Restoration of intestinal continuity was achieved in about 39%. Female patients without perianal CD carried no risk of a permanent stoma. LEVEL OF EVIDENCE: Level III study.

Pediatric sleep and autonomic complaints.

OBJECTIVES: Little is known about the relationship between autonomic dysfunction and sleep disturbances. This study aimed to identify patterns of sleep disturbances and autonomic dysfunction in children. METHODS: A retrospective chart review of 14 children who underwent sleep and autonomic testing was performed. Subjects were divided into three groups based on sudomotor Composite Autonomic Severity Score Scale score and postural tachycardia syndrome criteria. Sleep quality, sleep architecture, and number of comorbidities were analyzed. RESULTS: There were no statistically significant differences between groups in measures of sleep quality, sleep architecture, and number of comorbidities. CONCLUSION: Patients with postural tachycardia syndrome and autonomic dysfunction experience multiple sleep-related complaints. The low power of our study did not allow firm conclusions, but there is no pattern to these abnormalities.

Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial.

BACKGROUND: Development of safe and effective therapies for paediatric abdominal pain-related functional gastrointestinal disorders is needed. A non-invasive, US Food and Drug Administration-cleared device (Neuro-Stim, Innovative Health Solutions, IN, USA) delivers percutaneous electrical nerve field stimulation (PENFS) in the external ear to modulate central pain pathways. In this study, we evaluated the efficacy of PENFS in adolescents with abdominal pain-related functional gastrointestinal disorders. METHODS: In this randomised, sham-controlled trial, we enrolled adolescents (aged 11-18 years) who met Rome III criteria for abdominal pain-related functional gastrointestinal disorders from a single US outpatient gastroenterology clinic. Patients were randomly assigned (1:1) with a computer-generated randomisation scheme to active treatment or sham (no electrical charge) for 4 weeks. Patients were stratified by sex and presence or absence of nausea. Allocation was concealed from participants, caregivers, and the research team. The primary efficacy endpoint was change in abdominal pain scores. We measured improvement in worst abdominal pain and composite pain score using the Pain Frequency-Severity-Duration (PFSD) scale. Participants with less than 1 week of data and those with organic disease identified after enrolment were excluded from the modified intention-to-treat population. This trial has been completed and is registered with ClinicalTrials.gov, number NCT02367729. FINDINGS: Between June 18, 2015, and Nov 17, 2016, 115 children with abdominal pain-related functional gastrointestinal disorders were enrolled and assigned to either PENFS (n=60) with an active device or sham (n=55). After exclusion of patients who discontinued treatment (n=1 in the PENFS group; n=7 in the sham group) and those who were excluded after randomisation because they had organic disease (n=2 in the PENFS group; n=1 in the sham group), 57 patients in the PENFS group and 47 patients in the sham group were included in the primary analysis. Patients in the PENFS group had greater reduction in worst pain compared with sham after 3 weeks of treatment (PENFS: median score 5·0 [IQR 4·0-7·0]; sham: 7·0 [5·0-9·0]; least square means estimate of change in worse pain 2·15 [95% CI 1·37-2·93], p<0·0001). Effects were sustained for an extended period (median follow-up 9·2 weeks [IQR 6·4-13·4]) in the PENFS group: median 8·0 (IQR 7·0-9·0) at baseline to 6·0 (5·0-8·0) at follow-up versus sham: 7·5 (6·0-9·0) at baseline to 7·0 (5·0-8·0) at follow-up (p<0·0001). Median PFSD composite scores also decreased significantly in the PENFS group (from 24·5 [IQR 16·8-33.3] to 8·4 [3·2-16·2]) compared with sham (from 22·8 [IQR 8·4-38·2] to 15·2 [4·4-36·8]) with a mean decrease of 11·48 (95% CI 6·63-16·32; p<0·0001) after 3 weeks. These effects were sustained at extended follow-up in the PENFS group: median 24·5 (IQR 16·8-33·3) at baseline to 12 (3·6-22·5) at follow-up, compared with sham: 22·8 (8·4-38·2) at baseline to 16·8 (4·8-33·6) at follow-up (p=0·018). Ten patients reported side-effects (three of whom discontinued the study): ear discomfort (n=6; three in the PENFS group, three in the sham group), adhesive allergy (n=3; one in the PENFS group, two in the sham group), and syncope due to needle phobia (n=1; in the sham group). There were no serious adverse events. INTERPRETATION: Our results show that PENFS with Neuro-Stim has sustained efficacy for abdominal pain-related functional gastrointestinal disorders in adolescents. This safe and effective approach expands treatment options and should be considered as a non-pharmacological alternative for these disorders. FUNDING: American Neurogastroenterology and Motility Society.