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INTRODUCTION: Evidence about specific carbohydrate diet (SCD) for inflammatory bowel disease (IBD) is limited. We conducted 54 single-subject, double-crossover N-of-1 trials comparing SCD with a modified SCD (MSCD) and comparing each with the participant's baseline, usual diet (UD). METHODS: Across 19 sites, we recruited patients aged 7-18 years with IBD and active inflammation. Following a 2-week baseline (UD), patients were randomized to 1 of 2 sequences of 4 alternating 8-week SCD and MSCD periods. Outcomes included fecal calprotectin and patient-reported symptoms. We report posterior probabilities from Bayesian models comparing diets. RESULTS: Twenty-one (39%) participants completed the trial, 9 (17%) completed a single crossover, and 24 (44%) withdrew. Withdrawal or early completion occurred commonly (lack of response [n = 11], adverse events [n = 11], and not desiring to continue [n = 6]). SCD and MSCD performed similarly for most individuals. On average, there was <1% probability of a clinically meaningful difference in IBD symptoms between SCD and MSCD. The average treatment difference was -0.3 (95% credible interval -1.2, 0.75). There was no significant difference in the ratio of fecal calprotectin geometric means comparing SCD and MSCD (0.77, 95% credible interval 0.51, 1.10). Some individuals had improvement in symptoms and fecal calprotectin compared with their UD, whereas others did not. DISCUSSION: SCD and MSCD did not consistently improve symptoms or inflammation, although some individuals may have benefited. However, there are inherent difficulties in examining dietary changes that complicate study design and ultimately conclusions regarding effectiveness.
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Colitis Ulcerosa , Enfermedad de Crohn , Complejo de Antígeno L1 de Leucocito , Adolescente , Teorema de Bayes , Niño , Colitis Ulcerosa/complicaciones , Colitis Ulcerosa/dietoterapia , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/dietoterapia , Dieta , Heces/química , Humanos , Inflamación/complicaciones , Inflamación/dietoterapia , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/dietoterapia , Complejo de Antígeno L1 de Leucocito/análisis , Medicina de PrecisiónRESUMEN
BACKGROUND: Survivors of childhood, adolescent and young adult (CAYA) cancer may develop treatment-induced chronic liver disease. Surveillance guidelines can improve survivors' health outcomes. However, current recommendations vary, leading to uncertainty about optimal screening. The International Late Effects of Childhood Cancer Guideline Harmonization Group has developed recommendations for the surveillance of late hepatotoxicity after CAYA cancer. METHODS: Evidence-based methods based on the GRADE framework were used in guideline development. A multidisciplinary guideline panel performed systematic literature reviews, developed evidence summaries, appraised the evidence, and formulated recommendations on the basis of evidence, clinical judgement, and consideration of benefits versus the harms of the surveillance while allowing for flexibility in implementation across different health care systems. RESULTS: The guideline strongly recommends a physical examination and measurement of serum liver enzyme concentrations (ALT, AST, gGT, ALP) once at entry into long-term follow-up for survivors treated with radiotherapy potentially exposing the liver (moderate- to high-quality evidence). For survivors treated with busulfan, thioguanine, mercaptopurine, methotrexate, dactinomycin, hematopoietic stem cell transplantation (HSCT), or hepatic surgery, or with a history of chronic viral hepatitis or sinusoidal obstruction syndrome, similar surveillance for late hepatotoxicity once at entry into LTFU is reasonable (low-quality evidence/expert opinion, moderate recommendation). For survivors who have undergone HSCT and/or received multiple red blood cell transfusions, surveillance for iron overload with serum ferritin is strongly recommended once at long-term follow-up entry. CONCLUSIONS: These evidence-based, internationally-harmonized recommendations for the surveillance of late hepatic toxicity in cancer survivors can inform clinical care and guide future research of health outcomes for CAYA cancer survivors.
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Supervivientes de Cáncer , Hepatopatías/diagnóstico , Hepatopatías/etiología , Neoplasias/terapia , Traumatismos por Radiación/diagnóstico , Enfermedad Hepática Inducida por Sustancias y Drogas/diagnóstico , Humanos , Tamizaje Masivo/métodos , Neoplasias/mortalidad , Traumatismos por Radiación/etiologíaRESUMEN
Inflammatory bowel disease (IBD) affects 3 million children and adults in the US. Treatment involves medications with considerable risk profiles. Dietary modification, such as the specific carbohydrate diet (SCD), may be helpful in treating IBD, but there is insufficient evidence of its effectiveness. N-of-1 trials are ideal for addressing this important research question. The Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease (PRODUCE) study employs a series of 50 individual N-of-1 trials that compare the SCD to a modified SCD. Treatment periods are assigned in blocks of two, with each patient completing two balanced treatment blocks. Patients are randomized to start with the SCD or modified SCD and alternate between conditions for four eight-week periods. A mobile app guides collecting and viewing data, transitioning diets, and reviewing personal results. Primary outcomes include patient reported outcomes (PROs) of stool frequency, stool consistency, pain interference, and gastrointestinal (GI) symptom severity. We examine changes in inflammation via fecal calprotectin. Participants will receive a personalized answer regarding comparative effectiveness between the SCD and a less restrictive diet option (modified SCD), as well as compared to their baseline diet. We will aggregate the results of completed N-of-1 trials across patients to estimate population level comparative effectiveness of these treatments and the effectiveness of each diet.
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AIM: To evaluate maternal hepatitis B virus (HBV) DNA as risk for perinatal HBV infection among infants of HBV-infected women in California. METHODS: Retrospective analysis among infants born to hepatitis B surface antigen (HBsAg)-positive mothers who received post vaccination serologic testing (PVST) between 2005 and 2011 in California. Demographic information was collected from the California Department of Public Health Perinatal Hepatitis B Program databaseand matched to birth certificate records. HBV DNA level and hepatitis B e antigen (HBeAg) status were obtained from three large commercial laboratories in California and provider records if available and matched to mother infant pairs. Univariate analysis compared infected and uninfected infants. Multivariate analysis was restricted to infected infants and controls with complete maternal HBV DNA results using a predefined high HBV DNA level of > 2 × 107 IU/mL, a 5:1 ratio of cases to controls and a two-sided confidence level of 95%. RESULTS: A total of 17687 infants were born to HBsAg positive mothers in California between Jan 1 2005 and Dec 31, 2011. Among 11473 infants with PVST, only 125 (1.1%) were found to be HBV infected. Among these infected infants, lapses in Advisory Committee on Immunization Practices recommended post exposure prophylaxis (PEP) occurred in only 9 infants. However, PEP errors were not significantly different between infected and uninfected infants. Among the 347 uninfected and infected infants who had maternal HBeAg and HBV DNA level, case-control analysis found HBeAg positivity (70.4% vs 28.9%, OR = 46.76, 95%CI: 6.05-361.32, P < 0.001) and a maternal HBV DNA level ≥ 2 × 107 IU/mL (92.6% vs 18.5%, OR = 54.5, 95%CI: 12.22-247.55, P < 0.001) were associated with perinatal HBV infection. In multivariate logistic regression, maternal HBV DNA level ≥ 2 × 107 IU/mL was the only significant independent predictor of perinatal HBV infection. CONCLUSION: In California, transmission is low and most infected infants receive appropriate PEP and vaccination. Maternal HBV DNA ≥ 2 × 107 IU/mL is associated with high risk of perinatal infection.
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ADN Viral/aislamiento & purificación , Virus de la Hepatitis B/inmunología , Hepatitis B Crónica/transmisión , Transmisión Vertical de Enfermedad Infecciosa , Complicaciones Infecciosas del Embarazo/epidemiología , Adulto , California/epidemiología , Estudios de Casos y Controles , Femenino , Antígenos de Superficie de la Hepatitis B/aislamiento & purificación , Antígenos e de la Hepatitis B/aislamiento & purificación , Virus de la Hepatitis B/genética , Virus de la Hepatitis B/aislamiento & purificación , Hepatitis B Crónica/epidemiología , Hepatitis B Crónica/prevención & control , Hepatitis B Crónica/virología , Humanos , Incidencia , Recién Nacido , Masculino , Madres , Profilaxis Posexposición/métodos , Embarazo , Complicaciones Infecciosas del Embarazo/sangre , Complicaciones Infecciosas del Embarazo/prevención & control , Complicaciones Infecciosas del Embarazo/virología , Estudios Retrospectivos , Factores de Riesgo , Vacunación/métodos , Adulto JovenAsunto(s)
Enfermedad de Crohn/dietoterapia , Carbohidratos de la Dieta/uso terapéutico , Nutrición Enteral/métodos , Adolescente , Sedimentación Sanguínea , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/inmunología , Deprescripciones , Heces/química , Humanos , Inflamación , Complejo de Antígeno L1 de Leucocito/inmunología , Masculino , Metotrexato/uso terapéutico , Prednisona/uso terapéuticoRESUMEN
AIM: To investigate the specific carbohydrate diet (SCD) as nutritional therapy for maintenance of remission in pediatric Crohn's disease (CD). METHODS: Retrospective chart review was conducted in 11 pediatric patients with CD who initiated the SCD as therapy at time of diagnosis or flare. Two groups defined as SCD simple (diet alone, antibiotics or 5-ASA) or SCD with immunomodulators (corticosteroids and/or stable thiopurine dosing) were followed for one year and compared on disease characteristics, laboratory values and anthropometrics. RESULTS: The mean age at start of the SCD was 11.8 ± 3.0 years (range 6.6-17.6 years) with five patients starting the SCD within 5 wk of diagnosis. Three patients maintained a strict SCD diet for the study period and the mean time for liberalization was 7.7 ± 4.0 mo (range 1-12) for the remaining patients. In both groups, hematocrit, albumin and ESR values improved while on strict SCD and appeared stable after liberalization (P-value 0.006, 0.002, 0.002 respectively). The majority of children gained in weight and height percentile while on strict SCD, with small loss in weight percentile documented with liberalization. CONCLUSION: Disease control may be attainable with the SCD in pediatric CD. Further studies are needed to assess adherence, impact on mucosal healing and growth.
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Enfermedad de Crohn/dietoterapia , Dieta Baja en Carbohidratos , Carbohidratos de la Dieta/efectos adversos , Cooperación del Paciente , Adolescente , Desarrollo del Adolescente , Antibacterianos/uso terapéutico , Niño , Desarrollo Infantil , Terapia Combinada , Enfermedad de Crohn/diagnóstico , Enfermedad de Crohn/tratamiento farmacológico , Enfermedad de Crohn/metabolismo , Carbohidratos de la Dieta/metabolismo , Femenino , Fermentación , Humanos , Factores Inmunológicos/uso terapéutico , Masculino , Inducción de Remisión , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Aumento de PesoRESUMEN
BACKGROUND: Pediatric inflammatory bowel disease (IBD), consisting of Crohn's disease (CD) and ulcerative colitis (UC), can result in significant morbidity requiring frequent health care utilization. Although it is known that the overall financial impact of pediatric IBD is significant, the direct out-of-pocket (OOP) cost burden on the parents of children with IBD has not been explored. We hypothesized that affected children with a more relapsing disease course and families in lower income strata, ineligible for need-based assistance programs, disparately absorb ongoing financial stress. METHODS: We completed a cross-sectional analysis among parents of children with IBD residing in California using an online HIPAA-secure Qualtrics survey. Multicenter recruitment occurred between December 4, 2013 and September 18, 2014 at the point-of-care from site investigators, informational flyers distributed at regional CCFA conferences, and social media campaigns equally targeting Northern, Central, and Southern California. IBD-, patient-, and family-specific information were collected from the parents of pediatric patients with IBD patients younger than 18 years of age at time of study, carry a confirmed diagnosis of CD or UC, reside in and receive pediatric gastroenterology care in California, and do not have other chronic diseases requiring ongoing medical care. RESULTS: We collected 150 unique surveys from parents of children with IBD (67 CD; 83 UC). The median patient age was 14 years for both CD and UC, with an overall 3.7 years (SD 2.8 yr) difference between survey completion and time of IBD diagnosis. Annually, 63.6%, 28.6%, and 5.3% of families had an OOP cost burden >$500, >$1000, and >5000, respectively. Approximately one-third (36.0%) of patients had emergency department (ED) visits over the past year, with 59.2% of these patients spending >$500 on emergency department copays, including 11.1% who spent >$5000. Although 43.3% contributed <$500 on procedure and test costs, 20.0% spent >$2000 in the past year. Families with household income between $50,000 and $100,000 had a statistically significant probability (80.6%) of higher annual OOP costs than families with lower income <$50,000 (20.0%; P < 0.0001) or higher income >$100,000 (64.6%; P < 0.05). Multivariate analysis revealed that clinical variables associated with uncontrolled IBD states correlated to higher OOP cost burden. Annual OOP costs were more likely to be >$500 among patients who had increased spending on procedures and tests (odds ratio [OR], 5.63; 95% confidence interval [CI], 2.73-11.63), prednisone course required over the past year (OR, 3.19; 95% CI, 1.02-9.92), at least 1 emergency department visit for IBD symptoms (OR, 2.84; 95% CI, 1.33-6.06), at least 4 or more outpatient primary medical doctor visits for IBD symptoms (OR, 2.82; 95% CI, 1.40-5.68), and history of 4 or more lifetime hospitalizations for acute IBD care (OR, 2.60; 95% CI, 1.13-5.96). CONCLUSIONS: Previously undocumented, a high proportion of pediatric IBD families incur substantial OOP cost burden. Patients who are frequently in relapsing and uncontrolled IBD states require more acute care services and sustain higher OOP cost burden. Lower middle income parents of children with IBD ineligible for need-based assistance may be particularly at risk for financial stress from OOP costs related to ongoing medical care.
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Colitis Ulcerosa/economía , Costo de Enfermedad , Enfermedad de Crohn/economía , Financiación Personal/economía , Adolescente , California , Niño , Estudios de Cohortes , Estudios Transversales , Servicio de Urgencia en Hospital/economía , Encuestas de Atención de la Salud/estadística & datos numéricos , Hospitalización/economía , Humanos , Visita a Consultorio Médico/economía , Padres , Factores SocioeconómicosAsunto(s)
Adenoma de Células Hepáticas/epidemiología , Infecciones por Citomegalovirus/epidemiología , Enfermedades Intestinales/epidemiología , Neoplasias Hepáticas/epidemiología , Adenoma de Células Hepáticas/diagnóstico , Adenoma de Células Hepáticas/cirugía , Adolescente , Comorbilidad , Infecciones por Citomegalovirus/diagnóstico , Humanos , Enfermedades Intestinales/diagnóstico , Intestino Delgado/trasplante , Neoplasias Hepáticas/diagnóstico , Neoplasias Hepáticas/cirugía , Trasplante de Hígado , Masculino , Resultado del TratamientoRESUMEN
BACKGROUND AND OBJECTIVE: Increasingly, academic hospitals have adopted hospitalist-based systems of inpatient pediatric care. Some studies comparing hospitalists with other attending physicians have suggested trainees are more satisfied with education from hospitalists. However, there are published concerns that the increased presence of hospitalists may reduce residents' autonomy. The objective of the current study was to evaluate pediatric residents' perceptions of their own autonomy after a broad ward restructuring to hospitalist-led teams. METHODS: We analyzed data from standardized attending evaluations before and after a pediatric ward restructuring at an academic tertiary care hospital. Provision of most inpatient pediatric care changed from subspecialist-led teams to hospitalist-led teams. Numerical scores from evaluations before and after the restructuring were compared quantitatively. Comments from the evaluations were analyzed qualitatively to identify key themes. RESULTS: Before the restructuring, there were 65 evaluations of 5 hospitalists and 602 evaluations of 32 subspecialists. After the restructuring, there were 188 evaluations of 8 hospitalists. Hospitalists were rated significantly higher on all teaching attributes compared with all attending physicians before the restructuring. The attending role in promoting autonomy was mentioned infrequently and reflected residents' perceived lack of autonomy before the restructuring. The primary theme after the restructuring was autonomy, specifically emphasizing resident leadership and decision-making and the appropriate balance of resident autonomy and supervision. CONCLUSIONS: Although patient complexity was unchanged, a comparison of numerical ratings and resident comments before and after the restructuring indicates that hospitalists lead teams differently from subspecialists, with more emphasis on resident decision-making and autonomy.