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OBJECTIVE To describe celiac disease (CD) screening rates and glycemic outcomes of a gluten-free diet (GFD) in patients with type 1 diabetes who are asymptomatic for CD. RESEARCH DESIGN AND METHODS Asymptomatic patients (8–45 years) were screened for CD. Biopsy-confirmed CD participants were randomized to GFD or gluten-containing diet (GCD) to assess changes in HbA1c and continuous glucose monitoring over 12 months. RESULTS Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9–8.2%, N = 1,298] vs. 4.7% [95% CI 3.4–5.9%, N = 1,089], P = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%, P < 0.0001). Fifty-one participants were randomized to a GFD (N = 27) or GCD (N = 24). No HbA1c differences were seen between the groups (+0.14%, 1.5 mmol/mol; 95% CI −0.79 to 1.08; P = 0.76), although greater postprandial glucose increases (4-h +1.5 mmol/L; 95% CI 0.4–2.7; P = 0.014) emerged with a GFD. CONCLUSIONS CD is frequently observed in asymptomatic patients with type 1 diabetes, and clinical vigilance is warranted with initiation of a GFD.

Facial palsy can cause the impairment of eye closure and affect blink, ocular health, communication, and esthetics. Dynamic surgical procedures can restore eye closure in patients with decreased facial nerve function. There are no standardized measures of voluntary and spontaneous eye closure that are used to evaluate the outcomes of blink restoration procedures. The purpose of this systematic literature review was to identify the measures used to assess normal and abnormal eye closure and blinking in patients with facial palsy. A literature search of the PubMed database using the keyword “facial nerve/surgery” was conducted. Only English language articles that pertain to the use of facial paralysis assessment systems published in the past 20 years, which involve eyelid closure were included. There were 57 articles that used a facial paralysis classification system with an eyelid closure component: House-Brackmann Facial Nerve Grading Scale (n = 43, 67%); Sunnybrook Facial Grading Scale (n = 9); palpebral fissure heights (n = 4), and the electronic clinician-graded facial function tool (n = 3) and three additional measures were reported once. Although the Terzis and Bruno Scoring System, blink ratio, and electronic, clinician-graded facial function scale(eFACE) Clinician-Graded Scoring System were valid measures of eyelid closure, there was no one comprehensive eye assessment that demonstrated all aspects of eye closure in facial palsy, which include closure amplitude, spontaneity, and quality of life. For blink assessment, eFACE is the most comprehensive tool currently available and recommended to be used with a patient-reported quality of life supplement that captures the specific domains related to facial nerve dysfunction.

To develop a core outcome set (COS) for evaluating gastrostomy/gastrojejunostomy tube impact in children with neurological impairment.Healthcare providers/researchers and caregivers rated the importance of candidate outcomes on a 5-point Likert scale. Outcomes rated 'somewhat important' or 'very important' by most (≥85%) respondents were voted on during a consensus meeting. Outcomes that reached consensus for inclusion were ratified and assigned to Outcome Measures in Rheumatology filter core areas. The COS was validated in a separate group of caregivers.Twelve outcomes were selected from 120 candidate outcomes to form the COS. These included five 'Life Impact' outcomes, three 'Pathophysiological Manifestations' outcomes, two 'Resource Use' outcomes, one 'Growth and Development' outcome, and one 'Death' outcome.We developed an evidence-informed and consensus-based COS for use in studies of gastrostomy/gastrojejunostomy tube feeding in children with neurological impairment. Implementation of this COS will help reduce heterogeneity between studies and facilitate evidence-based decision-making.Caregivers, healthcare providers, and researchers ranked the importance of 120 outcomes. Twelve core outcomes were identified as essential to measure in future clinical research studies.CONJUNTO BÁSICO DE RESULTADOS PARA NIÑOS CON DETERIORO NEUROLÓGICO Y SONDA DE ALIMENTACIÓN: OBJETIVO: Desarrollar un conjunto básico de resultados (COS) para evaluar el impacto de la sonda de gastrostomía/gastro-yeyunostomía en niños con discapacidad neurológica. MÉTODO: Los proveedores/investigadores y cuidadores de salud calificaron la importancia de los resultados de los candidatos en una escala Likert de 5 puntos. Los resultados fueron calificados como “algo importantes” o “muy importantes” por la mayoría de los encuestados (85%) quienes votaron durante una reunión de consenso. Los resultados que llegaron a un consenso para la inclusión fueron ratificados y asignados a las medidas de resultado en las áreas centrales del filtro de reumatología. El COS fue validado en un grupo separado de cuidadores. RESULTADOS: Doce resultados fueron seleccionados de 120 candidatos para formar el COS. Estos incluyeron cinco resultados de “Impacto en la vida”, tres resultados de “Manifestaciones patológicas”, dos resultados de “uso de recursos”, un resultado de “Crecimiento y desarrollo” y un resultado de “Muerte”. INTERPRETACIÓN: Desarrollamos un COS basado en evidencia y basado en el consenso para su uso en estudios de sonda de alimentación por gastrostomía/gastro yeyunostomía en niños con discapacidad neurológica. La implementación de este COS ayudará a reducir la heterogeneidad entre los estudios y facilitará la toma de decisiones basadas en la evidencia.ITENS PRINCIPAIS PARA CRIANÇAS COM DEFICIÊNCIA NEUROLÓGICA E TUBO DE ALIMENTAÇÃO: OBJETIVO: Desenvolver um conjunto de itens principais (CIP) para avaliar o impacto do tubo de gastrostomia/gastrojejunostomia em crianças com deficiência neurológica. MÉTODO: Pesquisadores, profissionais da saúde, e cuidadores pontuaram a importância dos desfechos candidatos em uma escala Likert de 5 pontos. Os desfechos pontuados como “algo importante”ou “muito importante” pela maioria ‘(≥85%) dos respondentes foram votados durante um encontro para consenso. Os desfechos que obtiveram consenso foram ratificados e incluídos no filtro de itens principais das Medidas de Resultados em Reumatologia. O CIP foi validado em um grupo separado de cuidadores. RESULTADOS: Doze resultados foram selecionados a partir de 120 resultados candidatos para formar o CIP. Estes incluíram cinco resultados de “Impacto na vida”, três de Manifestações Patofisiológicas, um de “Crescimento e Desenvolvimento”, e um sobre “Morte”. INTERPRETAÇÃO: Desenvolvemos um CIP baseado em evidência e baseado em consenso para uso em estudos de alimentação por tubo de gastrostomia/gastrojejunostomia em crianças com deficiência neurológica. A implementation deste CIP irá ajudar a reduzir a heterogeneidade entre estudos e facilitar a tomada de decisões baseada em evidências.

Background: Celiac Disease (CD) is more common in individuals with type 1 diabetes (T1D) and is frequently asymptomatic. Despite this association, evidence as to the impact and diagnostic accuracy of CD screening is limited in asymptomatic patients with T1D. Objective: To describe CD serology and biopsy positivity rates in T1D patients screened as part of the Celiac Disease and Diabetes Dietary Intervention and Evaluation Trial (CD-DIET). Methods: Prospective data from patients, aged 8-45 years, with T1D screened at 22 sites across Ontario, Canada as part of CD-DIET were analyzed with respect to demographics, clinical symptoms and CD status. Serological and biopsy-confirmed rates of CD were evaluated. Results: Overall, 2585 patients were approached and 2386 patients completed serological testing using tissue transglutaminase antibodies. The sample included 1298 (54.4%) adults, aged 19-45 years, and 1088 (45.6%) pediatric subjects, aged 8-18 years. Mean age was 23.1 ± 10.3 years, 49.2% female, with mean duration of diabetes 12.2 ± 9.0 years. A small number of screened patients (N=45) were symptomatic for CD as per study criteria with clinical GI symptoms (n=39), osteoporosis (n=2), apthous ulcers (n=1), weight loss (n=1), and/or anemia (n=2). Overall, 140 asymptomatic patients were serologically positive for CD. A positive CD serology rate of 7.2% (94/1298) was seen in adults as compared to 4.2% (46/1088) in pediatric subjects (p=0.0064). Endoscopy was completed in 104 patients and CD was subsequently confirmed using duodenal biopsy in 54/71 adults (76.1%) and 28/33 pediatric patients (84.8%), with overall biopsy positivity rates of 4.2% and 2.6% respectively (p=0.034). Conclusions: Significant differences were observed in CD serology and biopsy positivity, with higher rates seen in adults as compared with children with T1D, which may be due to increasing risk of autoimmune co-morbidities with age as well as many adults being naïve to celiac disease screening. Disclosure F.H. Mahmud: None. A.B. Clarke: None. K.C. Joachim: None. E. Assor: None. A. Parikh: None. A. Advani: Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH. Other Relationship; Self; Boehringer Ingelheim GmbH. B.A. Perkins: Advisory Panel; Self; Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH, Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc., Abbott. Speaker's Bureau; Self; Abbott, Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Insulet Corporation. Speaker's Bureau; Self; Insulet Corporation, Dexcom, Inc.. B.R. Shah: None. C.S. Zuijdwijk: None. C. McDonald: None. D. Mack: None. D. Koltin: None. E. Hsieh: None. E.M. Szentgyorgyi: None. F. Saibil: None. G. Mukerji: None. H.A. Lochnan: Research Support; Self; Amylin Pharmaceuticals, Boston Therapeutics, Inc., Sanofi. J. Gilbert: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Sanofi. K. Bax: None. M.L. Lawson: None. M.D. Beaton: Advisory Panel; Self; Takeda Canada Inc., Janssen Pharmaceuticals, Inc., AbbVie Inc.. N.A. Saloojee: None. O. Lou: None. P.H. Gallego: None. R.L. Houlden: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., AstraZeneca, Eli Lilly and Company. R. Aronson: Other Relationship; Self; Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Sanofi, AstraZeneca. Research Support; Self; Eli Lilly and Company, Becton, Dickinson and Company, Merck & Co., Inc., Senseonics, Boehringer Ingelheim Pharmaceuticals, Inc.. S.E. Kirsch: None. W.G. Paterson: None. Z. Punthakee: Research Support; Self; Amgen, Astra Zeneca/Bristol Myers Squibb, Lexicon, Merck, NovoNordisk, Sanofi. Speaker's Bureau; Self; Abbott, Astra Zeneca/Bristol Myers Squibb, Boehringer Ingelheim/Eli Lilly, Janssen, Merck, NovoNordisk, Pfizer, Sanofi. Advisory Panel; Self; Astra Zeneca/Bristol Myers Squibb, Boehringer Ingelheim/Eli Lilly, Dexcom, Janssen, Medtronic, NovoNordisk, Pfizer, Sanofi. M.A. Marcon: None.

SummaryObjective The objective was to test whether the five-domain structure of the Measure of Processes of Care (MPOC-20) was observed in a sample of children with epilepsy and, if not, to propose adaptations to improve its utility in this population. Methods Data came from the Health-Related Quality of Life in Children with Epilepsy Study (HERQULES)—a multicenter prospective cohort study (n = 374) following children 4–12 years of age for 2 years after diagnosis. Confirmatory factor analysis (CFA) tested the applicability of the five domains/factors in a sample of children with epilepsy approximately 6 months following diagnosis (n = 311). Goodness-of-fit statistics were used to examine sources of ill model fit, and modification indices guided the model modification process where there was strong theoretical rationale for changes. Results The five-factor model described by the originators of the MPOC-20 was found to be inadmissible in children with epilepsy, with four of the five factors demonstrating high correlations (r > 0.85). Upon merging the intercorrelated factors, a two-factor solution with a mediocre fit emerged (Root Mean Square Error of Approximation (RMSEA) = 0.080, Comparative Fit Index (CFI) = 0.902, Standardized Root Mean Square Residual (SRMR) = 0.060). Modification indices identified four items as the source of poor model fit. Removing these four items and reperforming the CFA resulted in an adequate model fit and a revised 16-item MPOC (RMSEA = 0.057, CFI = 0.958, SRMR = 0.036). The two factors are “Family/Care Provider Interaction” and “Providing Information.” Significance Results suggest that the MPOC-16 better reflects family-centered care (FCC) in children with epilepsy than the original MPOC-20. The benefit of having fewer factors is that scoring is simpler and the interpretation of the results is easier. This was the first investigation of the factor structure of the MPOC-20 on a sample entirely composed of children with epilepsy. These results add to evidence that the factor structure (and how family-centered care is delivered and perceived) differs across treatment environments and treatment populations.

CONTEXT:Uncertainty exists about the impacts of feeding tubes on neurologically impaired children. Core outcome sets (COS) standardize outcome selection, definition, measurement, and reporting.OBJECTIVE:To synthesize an evidence base of qualitative data on all outcomes selected and/or reported for neurologically impaired children 0 to 18 years living with gastrostomy/gastrojejunostomy tubes.DATA SOURCES:Medline, Embase, and Cochrane Register databases searched from inception to March 2014.STUDY SELECTION:Articles examining health outcomes of neurologically impaired children living with feeding tubes.DATA EXTRACTION:Outcomes were extracted and assigned to modified Outcome Measures in Rheumatology 2.0 Filter core areas; death, life impact, resource use, pathophysiological manifestations, growth and development.RESULTS:We identified 120 unique outcomes with substantial heterogeneity in definition, measurement, and frequency of selection and/or reporting: “pathophysiological manifestation” outcomes (n = 83) in 79% of articles; “growth and development” outcomes (n = 13) in 55% of articles; “death” outcomes (n = 3) and “life impact” outcomes (n = 17) in 39% and 37% of articles, respectively; “resource use” outcomes (n = 4) in 14%. Weight (50%), gastroesophageal reflux (35%), and site infection (25%) were the most frequently reported outcomes.LIMITATIONS:We were unable to investigate effect size of outcomes because quantitative data were not collected.CONCLUSIONS:The paucity of outcomes assessed for life impact, resource use and death hinders meaningful evidence synthesis. A COS could help overcome the current wide heterogeneity in selection and definition. These results will form the basis of a consensus process to produce a final COS.

Background Evidence suggests that newborn and child health systematic reviews and meta-analyses exhibit poor quality in reporting. The “Preferred Reporting Items in Systematic Review and Meta-Analysis” (PRISMA) and PRISMA-Protocols (PRISMA-P) checklists have been developed to improve the reporting of systematic review results and protocols, respectively. We aimed to evaluate the clarity and transparency in reporting of child-centric items in child health systematic reviews (SRs) and SR protocols and to identify areas where reporting could be strengthened. Methods Two preliminary lists of potential child-centric reporting items were used to examine current reporting. The Cochrane, DARE, MEDLINE, and EMBASE libraries were searched from 2010 to 2014 for systematic reviews that included children. Each report and protocol that met the inclusion criteria had their quality of reporting assessed by their reporting of child-centric items. Quality of reporting was assessed per whether one third, one to two thirds, or more than two thirds of papers complied with potential child-centric potential modifications/extensions to PRISMA and were analyzed by the following: (i) paper type (i.e., report vs. protocol), (ii) publication type (i.e., Cochrane vs. non-Cochrane), and (iii) population type (i.e., child-only vs. mixed populations vs. family/maternal). Results Of the 414 eligible articles, 248 reports and 76 protocols were included. In 21 of 24 potential SR reporting items and 13 of 14 potential SR protocol reporting items, less than two thirds of papers met the child-centric reporting item requirements. Mixed population studies displayed significantly poorer reporting in comparison to child-only and family/maternal intervention studies for 11 potential SR reporting items (p