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1.
Am J Lifestyle Med ; 18(2): 156-161, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38559781

RESUMEN

This commentary critiques the Danish CHANGE trial, which evaluated 3 levels of outpatient intervention intensity, in a group of outpatients with obesity and schizophrenia. Neither adding care coordination with weekly nurse contacts alone nor combining this treatment with assertive community lifestyle coaching as compared to treatment as usual improved outcomes, which included cardiovascular disease risk calculation, cardiorespiratory fitness, weight, and self-reported behaviors such as smoking, physical activity, and diet. The CHANGE trial investigators appear strongly averse to recommending the development and implementation of lifestyle medicine programs as a major component when treating outpatients with severe mental disorders. The potential dismissal of lifestyle medicine as a component of treatment for severe mental disorders is problematic. Valuable lessons can be learned from more thoroughly analyzing secondary outcomes such as medical and psychiatric hospitalization rates and total health care cost. The CHANGE trial data analysis needs to be expanded beyond the focus on changes in weight and serum cholesterol. Insulin resistance and high refined carbohydrate intake may be major factors in determining both the medical and psychiatric clinical course of schizophrenia. Assertive community lifestyle coaching is a novel treatment modality. Evidence strongly suggests assertive community lifestyle coaching substantially decreases both psychiatric and medical hospitalization rates.

2.
BMC Health Serv Res ; 24(1): 540, 2024 Apr 27.
Artículo en Inglés | MEDLINE | ID: mdl-38678236

RESUMEN

BACKGROUND: The primary healthcare system in Pakistan focuses on providing episodic, disease-based care. Health care for low-middle income communities is largely through a fee-for-service model that ignores preventive and health-promotive services. The growing burden of cardiovascular illnesses requires restructuring of the primary health care system allowing a community-to-clinic model of care to improve patient- and community-level health indicators. METHODS: We propose a model that integrates a Patient-Centered Medical Home (PCMH) with a Community-Based Health Information System (CBHIS) using hypertension (HTN) as an example. This protocol describes the integration and evaluation of the PCMH-CBHIS infrastructure through a population-based, observational, longitudinal study in a low-middle income, urban community in Pakistan. Participants are being enrolled in CBHIS and will be followed longitudinally over two years for HTN outcomes. A mixed-methods approach is adopted to evaluate the process of integrating PCMH with CBHIS. This involves building partnerships with the community through formal and informal meetings, focus group discussions, and a household health assessment survey (HAS). Community members identified with HTN are linked to PCMH for disease management. A customized electronic medical record system links community-level data with patient-level data to track changes in disease burden. The RE-AIM evaluation framework will be used to monitor community and individual-level metrics to guide implementation assessment, the potential for generalization, and the effectiveness of the PCMH in improving HTN-related health outcomes. Ethical clearance has been obtained from the Ethics Review Committee at Aga Khan University (2022-6723-20985). DISCUSSION: This study will evaluate the value of restructuring the primary care health system by ensuring systematic community engagement and measurement of health indicators at the patient- and community-level. While HTN is being used as a prototype to generate evidence for the effectiveness of this model, findings from this initiative will be leveraged towards strengthening the management of other acute and chronic conditions in primary care settings. If effective, the model can be used in Pakistan and other LMICs and resource-limited settings.


Asunto(s)
Hipertensión , Atención Dirigida al Paciente , Humanos , Atención Dirigida al Paciente/organización & administración , Hipertensión/terapia , Estudios Longitudinales , Pakistán , Servicios de Salud Comunitaria/organización & administración , Atención Primaria de Salud/organización & administración , Mejoramiento de la Calidad/organización & administración , Masculino , Femenino
3.
BMJ Case Rep ; 17(2)2024 Feb 22.
Artículo en Inglés | MEDLINE | ID: mdl-38388200

RESUMEN

Measurement of graft dysfunction following kidney transplant through creatinine is well known to be impacted by many different factors. We report here a clinical scenario demonstrating the importance of dual measurement of glomerular filtration rate (GFR) based on creatinine and cystatin C while also examining within-subject variability of both tests.


Asunto(s)
Lesión Renal Aguda , Alimentos , Trasplante de Riñón , Humanos , Lesión Renal Aguda/sangre , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Biomarcadores , Creatinina , Cistatina C , Tasa de Filtración Glomerular , Alimentos/efectos adversos
4.
J Clin Oncol ; 42(5): 562-570, 2024 Feb 10.
Artículo en Inglés | MEDLINE | ID: mdl-37988638

RESUMEN

PURPOSE: Standard therapy for locally advanced non-small-cell lung cancer (LA-NSCLC) is concurrent chemoradiotherapy followed by adjuvant durvalumab. For biomarker-selected patients with LA-NSCLC, we hypothesized that sequential pembrolizumab and risk-adapted radiotherapy, without chemotherapy, would be well-tolerated and effective. METHODS: Patients with stage III NSCLC or unresectable stage II NSCLC and an Eastern Cooperative Oncology Group performance status of 0-1 were eligible for this trial. Patients with a PD-L1 tumor proportion score (TPS) of ≥50% received three cycles of induction pembrolizumab (200 mg, once every 21 days), followed by a 20-fraction course of risk-adapted thoracic radiotherapy (55 Gy delivered to tumors or lymph nodes with metabolic volume exceeding 20 cc, 48 Gy delivered to smaller lesions), followed by consolidation pembrolizumab to complete a 1-year treatment course. The primary study end point was 1-year progression-free survival (PFS). Secondary end points included response rates after induction pembrolizumab, overall survival (OS), and adverse events. RESULTS: Twenty-five patients with a PD-L1 TPS of ≥50% were enrolled. The median age was 71, most patients (88%) had stage IIIA or IIIB disease, and the median PD-L1 TPS was 75%. Two patients developed disease progression during induction pembrolizumab, and two patients discontinued pembrolizumab after one infusion because of immune-related adverse events. Using RECIST criteria, 12 patients (48%) exhibited a partial or complete response after induction pembrolizumab. Twenty-four patients (96%) received definitive thoracic radiotherapy. The 1-year PFS rate is 76%, satisfying our efficacy objective. One- and 2-year OS rates are 92% and 76%, respectively. The most common grade 3 adverse events were colitis (n = 2, 8%) and esophagitis (n = 2, 8%), and no higher-grade treatment-related adverse events have occurred. CONCLUSION: Pembrolizumab and risk-adapted radiotherapy, without chemotherapy, are a promising treatment approach for patients with LA-NSCLC with a PD-L1 TPS of ≥50%.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Humanos , Anciano , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/radioterapia , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/radioterapia , Radioinmunoterapia/efectos adversos , Antígeno B7-H1/metabolismo , Supervivencia sin Progresión
5.
Int J Mol Sci ; 24(14)2023 Jul 24.
Artículo en Inglés | MEDLINE | ID: mdl-37511598

RESUMEN

Trichomoniasis, caused by Trichomonas vaginalis (TV), is the most common non-viral sexually transmitted infection (STI) worldwide, affecting over 174 million people annually and is frequently associated with reproductive co-morbidities. However, its detection can be time-consuming, subjective, and expensive for large cohort studies. This case-control study, conducted at the Mount Sinai Adolescent Health Center in New York City, involved 36 women with prevalent TV infections and 36 controls. The objective was to examine Internal Transcribed Spacer region-1 (ITS1) amplicon-derived communities for the detection of prevalent TV infections with the same precision as clinical microscopy and the independent amplification of the TV-specific TVK3/7 gene. DNA was isolated from clinician-collected cervicovaginal samples and amplified using ITS1 primers in a research laboratory. Results were compared to microscopic wet-mount TV detection of concurrently collected cervicovaginal samples and confirmed against TV-specific TVK3/7 gene PCR. The area under the receiver operating characteristics curve (AUC) for diagnosing TV using ITS1 communities was 0.92. ITS1 amplicons displayed an intra-class correlation coefficient (ICC) of 0.96 (95% CI: 0.93-0.98) compared to TVK3/7 PCR fragment testing. TV cases showed an increased risk of bacterial vaginosis (BV) compared to the TV-negative controls (OR = 8.67, 95% CI: 2.24-48.54, p-value = 0.0011), with no significant differences regarding genital yeast or chlamydia infections. This study presents a bioinformatics approach to ITS1 amplicon next-generation sequencing that is capable of detecting prevalent TV infections. This approach enables high-throughput testing for TV in stored DNA from large-scale epidemiological studies.


Asunto(s)
Vaginitis por Trichomonas , Trichomonas vaginalis , Adolescente , Femenino , Humanos , Trichomonas vaginalis/genética , Vaginitis por Trichomonas/diagnóstico , Estudios de Casos y Controles , Reacción en Cadena de la Polimerasa/métodos , Técnicas de Amplificación de Ácido Nucleico , Prevalencia
6.
ASAIO J ; 69(11): 977-983, 2023 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-37499684

RESUMEN

The use of intra-aortic balloon pump (IABP) has decreased in recent years due to negative outcome studies in cardiogenic shock complicating acute myocardial infarction, despite its favorable adverse-event profile. Acute hemodynamic response studies have identified potential super-responders with immediate improvements in cardiac index (CI) in heart failure patients. This single-center retrospective study aimed to predict CI and mean arterial pressure (MAP) changes throughout the entire duration of IABP support. The study analyzed 336 patients who received IABP between 2016 and 2022. Linear mixed-effect regression models were used to predict CI and MAP improvement during IABP support. The results showed that CI and MAP increases during the first days of support, and changes during IABP support varied with time and were associated with baseline parameters. Longitudinal CI change was associated with body surface area, baseline CI, baseline pulmonary artery pulsatility index, baseline need for pressors, and diabetes. Longitudinal MAP change was associated with baseline MAP, baseline heart rate, need for pressors, or inotropes. The study recommends considering these parameters when deciding if IABP is the most appropriate form of support for a specific patient. Further prospective studies are needed to validate the findings.


Asunto(s)
Insuficiencia Cardíaca , Infarto del Miocardio , Humanos , Estudios Retrospectivos , Choque Cardiogénico/cirugía , Infarto del Miocardio/complicaciones , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/complicaciones , Hemodinámica/fisiología
7.
Pediatr Nephrol ; 38(12): 4165-4173, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37422606

RESUMEN

BACKGROUND: Metabolic acidosis is a risk factor for faster kidney function decline in chronic kidney disease (CKD) and in adult kidney transplant recipients (KTRs). We hypothesized that metabolic acidosis would be highly prevalent and associated with worse allograft function in pediatric KTRs. METHODS: Pediatric KTRs at Montefiore Medical Center from 2010 to 2018 were included. Metabolic acidosis was defined as serum bicarbonate < 22 mEq/L or receiving alkali therapy. Regression models were adjusted for demographic factors and donor/recipient characteristics. RESULTS: Sixty-three patients were identified with a median age at transplant of 10.5 (interquartile range (IQR) 4.4-15.2) years and post-transplant follow-up of 3 (IQR 1-5) years. Baseline serum bicarbonate was 21.7 ± 2.4 mEq/L, serum bicarbonate < 22 mEq/L was present in 28 (44%), and 44% of all patients were receiving alkali therapy. The prevalence of acidosis ranged from 58 to 70% during the first year of follow-up. At baseline, each 1-year higher age at transplant and every 10 ml/min/1.73 m2 higher eGFR were associated with 0.16 mEq/L (95% CI: 0.03-0.3) and 0.24 mEq/L (95% CI: 0.01-0.5) higher serum bicarbonate, respectively. Older age at transplant was associated with lower odds of acidosis (OR: 0.84; 95% CI: 0.72-0.97). During follow-up, metabolic acidosis was independently associated with 8.2 ml/min/1.73 m2 (95% CI 4.4-12) lower eGFR compared to not having acidosis; furthermore, eGFR was significantly lower among KTRs with unresolved acidosis compared with resolved acidosis. CONCLUSIONS: Among pediatric KTRs, metabolic acidosis was highly prevalent in the first year post-transplantation and was associated with lower eGFR during follow-up. A higher resolution version of the Graphical abstract is available as Supplementary information.


Asunto(s)
Acidosis , Trasplante de Riñón , Insuficiencia Renal Crónica , Adulto , Humanos , Niño , Preescolar , Adolescente , Trasplante de Riñón/efectos adversos , Bicarbonatos , Acidosis/epidemiología , Acidosis/etiología , Insuficiencia Renal Crónica/epidemiología , Insuficiencia Renal Crónica/cirugía , Insuficiencia Renal Crónica/complicaciones , Receptores de Trasplantes , Álcalis
8.
J Neurosurg Pediatr ; 32(3): 285-293, 2023 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-37243563

RESUMEN

OBJECTIVE: Venous thromboembolism (VTE) chemoprophylaxis in pediatric patients with traumatic brain injury (TBI) requires balancing the risk of progression of intracranial bleeding versus the risk of VTE. The identification of VTE risk factors requires analysis of a very large data set. This case-control study aimed to identify VTE risk factors in pediatric patients with TBI in order to develop a TBI-specific association model that can be used for VTE risk stratification in this population. METHODS: The study included patients (aged 1-17 years) from the 2013-2019 US National Trauma Data Bank who were admitted for TBI in order to identify risk factors for VTE. Stepwise logistic regression was used to develop an association model. RESULTS: Of 44,128 study participants, 257 (0.58%) developed VTE. Risk factors associated with VTE included age (OR 1.045, 95% CI 1.010-1.080), body mass index (OR 1.034, 95% CI 1.013-1.055), Injury Severity Score (OR 1.049, 95% CI 1.039-1.059), blood product administration (OR 1.436, 95% CI 1.008-2.046), presence of a central venous catheter (OR 3.333, 95% CI 2.431-4.571), and development of ventilator-associated pneumonia (OR 3.650, 95% CI 2.469-5.396). Based on this model, the predicted VTE risk in pediatric patients with TBI ranged from 0% to 16.8%. CONCLUSIONS: A model that includes age, body mass index, Injury Severity Score, blood transfusion, use of a central venous catheter, and ventilator-associated pneumonia can help to risk stratify pediatric patients with TBI from the standpoint of implementation of VTE chemoprophylaxis.


Asunto(s)
Lesiones Traumáticas del Encéfalo , Neumonía Asociada al Ventilador , Tromboembolia Venosa , Humanos , Niño , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Estudios de Casos y Controles , Neumonía Asociada al Ventilador/complicaciones , Lesiones Traumáticas del Encéfalo/complicaciones , Lesiones Traumáticas del Encéfalo/epidemiología , Factores de Riesgo
9.
Int J Inj Contr Saf Promot ; 30(3): 352-361, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36905635

RESUMEN

Spousal physical violence (PV) against women is considered to be major health issue in developing countries. Lifetime physical violence is a composite outcome consists of hit, kick, beat, slap and threatened with weapon, perpetrated by the husband. The study aims to examine changes in prevalence and specific risk factors for PV from 1998 to 2016 in India. This study analyzed data from a cross sectional epidemiological survey in 1998-1999, NFHS-3 (2005-2006) and NFHS-4 (2015-2016) data. There was a significant decline of about 10% (95% CI: 8.8%-11.1%) in PV. Major risk factors for change in PV were husband's use of alcohol, illiteracy and socio-economic status of the household. The Protection of Women from Domestic Violence Act may have played a role in reducing the PV. Even though there was a decline in PV, actions have to be implemented from the root level to ensure women empowerment.


Asunto(s)
Maltrato Conyugal , Humanos , Femenino , Maltrato Conyugal/prevención & control , Abuso Físico , Prevalencia , Estudios Transversales , Factores de Riesgo , India/epidemiología
10.
JCO Oncol Pract ; 19(6): e904-e915, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-37001038

RESUMEN

PURPOSE: Incremental delays in time to treatment initiation (TTI) have been shown to cause a proportional, increased independent risk of disease-specific mortality for breast cancer, colorectal cancer (CRC), head and neck cancer (HNC), non-small-cell lung cancer (NSCLC), and pancreatic cancer. Studies suggest that delays are associated with racial and socioeconomic disparities. We evaluated associations between patient factors and TTI to identify those associated with delay. MATERIALS AND METHODS: This is a retrospective cohort study at an urban community-based academic center of patients diagnosed with or referred for curative-intent treatment of breast cancer, CRC, HNC, NSCLC, and pancreatic cancer from January 2019 to December 2021. Variables of interest included Charlson Comorbidity Index (CCI) score, insurance type, language preference, and inpatient admission 30 days before diagnosis. Factors associated with TTI delay, defined as TTI ≥ 30 days, were assessed using multivariable logistic regression. RESULTS: Among 2,543 patients (69% female), the mean age was 63.4 years and the median TTI was 25 days (IQR, 6-44). Within multivariable models, patients treated as outpatient and not admitted 30 days before diagnosis experienced statistically significant greater delay for CRC (odds ratio [OR], 2.82; 95% CI, 1.71 to 4.66) and NSCLC (OR, 2.11; 95% CI, 1.31 to 3.39). Higher CCI score was associated with delay for HNC (OR, 2.63; 95% CI, 1.04 to 6.66) and NSCLC (OR, 1.75; 95% CI, 1.14 to 2.71). For breast cancer, uninsured and Spanish-speaking patients (OR, 1.79; 95% CI, 1.21 to 2.67) experienced increased TTI. CONCLUSION: Care coordination/compliance (eg, inpatient 30 days before diagnosis), clinical (eg, medical comorbidities), and socioeconomic (eg, uninsured status) predictors for delayed TTI were identified and may inform delay minimizing interventions. Our data support evidence that TTI delays are associated with demographic and socioeconomic disparities. Existing disparities are likely exacerbated by delays that disproportionately affect patients with care coordination/compliance issues, multiple comorbidities, and lower socioeconomic status.


Asunto(s)
Neoplasias de la Mama , Carcinoma de Pulmón de Células no Pequeñas , Neoplasias de Cabeza y Cuello , Neoplasias Pulmonares , Neoplasias Pancreáticas , Humanos , Femenino , Persona de Mediana Edad , Masculino , Tiempo de Tratamiento , Estudios Retrospectivos , Población Urbana , Neoplasias Pancreáticas
11.
Appl Clin Inform ; 14(2): 365-373, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36822226

RESUMEN

BACKGROUND: Residents of the Bronx suffer marked health disparities due to socioeconomic and other factors. The coronavirus disease 2019 pandemic worsened these health outcome disparities and health care access disparities, especially with the abrupt transition to online care. OBJECTIVES: This study classified electronic health literacy (EHL) among patients at an urban, academic hospital in the Bronx, and assessed for associations between EHL levels and various demographic characteristics. METHODS: We designed a cross-sectional, observational study in adults 18 years or older presenting to the Montefiore Einstein Center for Cancer Care (MECCC) Department of Radiation Oncology or the Montefiore Department of Medicine in the Bronx. We assessed EHL using the eHealth Literacy Scale (eHEALS) survey, a previously validated tool, and our newly developed eHealth Literacy Objective Scale-Scenario Based (eHeLiOS-SB) tool. RESULTS: A total of 97 patients recruited from the MECCC and Department of Medicine participated in this study. There was a statistically significant association between age and EHL as assessed by both eHEALS and eHeLiOS-SB, with older adults having lower EHL scores. Additionally, a question designed to assess general attitudes toward digital health technologies found that most participants had a positive attitude toward such applications. CONCLUSION: Many patients, especially older adults, may require additional support to effectively navigate telehealth. Further research is warranted to optimize telemedicine strategies in this potentially-marginalized population and ultimately to create telehealth practices accessible to patients of all ages and demographics.


Asunto(s)
COVID-19 , Alfabetización en Salud , Telemedicina , Humanos , Anciano , Estudios Transversales , COVID-19/epidemiología , Electrónica , Encuestas y Cuestionarios , Hospitales , Internet
12.
Nat Commun ; 13(1): 233, 2022 01 11.
Artículo en Inglés | MEDLINE | ID: mdl-35017496

RESUMEN

Bacterial vaginosis (BV) is a highly prevalent condition that is associated with adverse health outcomes. It has been proposed that BV's role as a pathogenic condition is mediated via bacteria-induced inflammation. However, the complex interplay between vaginal microbes and host immune factors has yet to be clearly elucidated. Here, we develop molBV, a 16 S rRNA gene amplicon-based classification pipeline that generates a molecular score and diagnoses BV with the same accuracy as the current gold standard method (i.e., Nugent score). Using 3 confirmatory cohorts we show that molBV is independent of the 16 S rRNA region and generalizable across populations. We use the score in a cohort without clinical BV states, but with measures of HPV infection history and immune markers, to reveal that BV-associated increases in the IL-1ß/IP-10 cytokine ratio directly predicts clearance of incident high-risk HPV infection (HR = 1.86, 95% CI: 1.19-2.9). Furthermore, we identify an alternate inflammatory BV signature characterized by elevated TNF-α/MIP-1ß ratio that is prospectively associated with progression of incident infections to CIN2 + (OR = 2.81, 95% CI: 1.62-5.42). Thus, BV is a heterogeneous condition that activates different arms of the immune response, which in turn are independent risk factors for HR-HPV clearance and progression. Clinical Trial registration number: The CVT trial has been registered under: NCT00128661.


Asunto(s)
Infecciones por Papillomavirus/virología , Vagina/microbiología , Vagina/virología , Vaginosis Bacteriana/microbiología , Adolescente , Adulto , Alphapapillomavirus/genética , Bacterias , Citocinas , Femenino , Humanos , Interleucina-1beta/metabolismo , Metagenómica , Medicina Molecular , Neoplasias/epidemiología , Infecciones por Papillomavirus/tratamiento farmacológico , Factores de Riesgo , Vaginosis Bacteriana/tratamiento farmacológico , Adulto Joven
13.
JPGN Rep ; 2(2)2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-34723254

RESUMEN

OBJECTIVES: The relationship between vitamin D deficiency (VDD) and pediatric nonalcoholic fatty liver disease (NAFLD) remains uncertain due to conflicting results and few studies with histologic endpoints. We therefore used multiple imaging and histologic NAFLD endpoints to more comprehensively assess the association between VDD and NAFLD in a large pediatric population. METHODS: Data were obtained from an ongoing pediatric NAFLD study in Bronx, NY. Briefly, overweight and obese children aged 2-18 years with alanine aminotransferase (ALT) levels ≥ 35 U/L were serially enrolled. Liver biopsy was obtained in accordance with clinical guidelines. All participants had liver imaging, namely, controlled attenuation parameter (CAP; Echosens, France) to assess steatosis and, to assess fibrosis, vibration controlled transient elastography (VCTE; FibroScan™, Echosens, France) and acoustic radiation force impulse (ARFI; Philips, Netherlands) imaging. Levels of 25-hydroxyvitamin D were measured serologically. RESULTS: N=276 (88%) of 315 participants had 25-OH vitamin D results, of whom 241 (87%) were Hispanic, 199 (72%) were male, and 92 (33%) underwent liver biopsy. VDD was univariately associated with high waist circumference (p=0.004), high-density lipoprotein level (p=0.01), season (p=0.009), and CAP score (p=0.01). In multivariate analysis, only waist circumference (p=0.0002) and biopsy inflammation grade (p=0.03) were associated with VDD, though the latter had not approximated statistical significance in univariate analysis (p=0.56). There was no association between VDD and hepatic steatosis, ballooning, NAFLD Activity Score, ARFI or VCTE elasticity scores. CONCLUSIONS: VDD was not associated with NAFLD defined by imaging and histologic endpoints, except for a possible relation with histologic inflammation grade.

14.
Ann Allergy Asthma Immunol ; 126(4): 367-377.e5, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33418053

RESUMEN

BACKGROUND: Allergic sensitization to environmental allergens in the first years of life is a strong predictor of asthma morbidity in children. Allergy immunotherapy can improve asthma and allergy outcomes, but its efficacy in inner-city, atopic children of less than 4 years of age with recurrent wheezing has not yet been established. OBJECTIVE: To determine whether subcutaneous allergy immunotherapy improves asthma in a population of US inner-city children when started at less than 4 years of age. METHODS: In a randomized controlled, open-label phase I-II single-center trial in the Bronx, New York, 58 children with recurrent wheezing or physician-diagnosed asthma were randomized to receive asthma standard of care treatment with or without a 3-year course of multiple allergen subcutaneous immunotherapy. RESULTS: A total of 23 children in the control group and 27 children in the immunotherapy group began the study. A total of 20 of 27 children commencing immunotherapy completed at least 2 years of immunotherapy. There was no difference in asthma medication and symptom scores between the treatment or control groups over time. Similarly, naso-ocular symptoms and allergy medication use were similar in both groups over time. Nevertheless, asthma-related quality of life improved in the immunotherapy group compared with the control group (P = .03). CONCLUSION: With the exception of asthma-related quality of life, allergy immunotherapy was ineffective in improving asthma outcomes in this population of inner-city children of less than 4 years of age. These findings suggest that the effects of allergy immunotherapy depend on population-specific factors and highlight the importance of precise predictors of immunotherapy efficacy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01028560.


Asunto(s)
Asma/inmunología , Asma/terapia , Hipersensibilidad/inmunología , Hipersensibilidad/terapia , Alérgenos/inmunología , Preescolar , Desensibilización Inmunológica/métodos , Femenino , Humanos , Hipersensibilidad Inmediata/inmunología , Hipersensibilidad Inmediata/terapia , Masculino , New York , Calidad de Vida , Ruidos Respiratorios/inmunología
15.
Lupus Sci Med ; 6(1): e000348, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31649825

RESUMEN

OBJECTIVE: A common problem in clinical trials is missing data due to participant dropout and loss to follow-up, an issue which continues to receive considerable attention in the clinical research community. Our objective was to examine and compare current and alternative methods for handling missing data in SLE trials with a particular focus on multiple imputation, a flexible technique that has been applied in different disease settings but not to address missing data in the primary outcome of an SLE trial. METHODS: Data on 279 patients with SLE randomised to standard of care (SoC) and also receiving mycophenolate mofetil (MMF), azathioprine or methotrexate were obtained from the Lupus Foundation of America-Collective Data Analysis Initiative Database. Complete case analysis (CC), last observation carried forward (LOCF), non-responder imputation (NRI) and multiple imputation (MI) were applied to handle missing data in an analysis to assess differences in SLE Responder Index-5 (SRI-5) response rates at 52 weeks between patients on SoC treated with MMF versus other immunosuppressants (non-MMF). RESULTS: The rates of missing data were 32% in the MMF and 23% in the non-MMF groups. As expected, the NRI missing data approach yielded the lowest estimated response rates. The smallest and least significant estimates of differences between groups were observed with LOCF, and precision was lowest with the CC method. Estimated between-group differences were magnified with the MI approach, and imputing SRI-5 directly versus deriving SRI-5 after separately imputing its individual components yielded similar results. CONCLUSION: The potential advantages of applying MI to address missing data in an SLE trial include reduced bias when estimating treatment effects, and measures of precision that properly reflect uncertainty in the imputations. However, results can vary depending on the imputation model used, and the underlying assumptions should be plausible. Sensitivity analysis should be conducted to demonstrate robustness of results, especially when missing data proportions are high.

16.
Contemp Clin Trials ; 75: 51-58, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-30401631

RESUMEN

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is strongly associated with obesity and is the most common liver disease in the developed world. In children with suspected NAFLD, present guidelines suggest consideration of alternative diagnoses via extensive blood testing, though the yield of this work up is unknown. Furthermore, the gold standard diagnostic test for NAFLD remains liver biopsy, making the development of non-invasive tests critically important. OBJECTIVES: Our objectives are: 1) to determine the accuracy of elastography and multiple serum biomarkers - each assessed individually and as algorithms (including those previously tested in adults) - for the diagnosis of nonalcoholic steatohepatitis (NASH) and early fibrosis in children and (2) to examine the utility of extensive testing for rare alternative diagnoses in overweight or obese children with elevated alanine aminotransferase (ALT) suspected to have NAFLD. DESIGN: This is an ongoing, cross-sectional study in children 2-18 years of age with up to 2 years of prospective follow up. Eligible patients are asymptomatic, overweight or obese, and have an ALT ≥35 U/L upon enrollment. Two forms of elastography are obtained serially along with anthropometric data and routine laboratory tests. Elastography and serum biomarkers are also performed immediately prior to any clinically-indicated biopsy. METHODS: Between April 2015 and April 2018, 193 children have been enrolled in this ongoing study and 71 have undergone liver biopsy. Here we carefully report the rationale, methodology, and preliminary data for this study.


Asunto(s)
Hígado/diagnóstico por imagen , Enfermedad del Hígado Graso no Alcohólico/diagnóstico , Adolescente , Alanina Transaminasa/sangre , Biomarcadores/sangre , Biopsia , Niño , Preescolar , Estudios Transversales , Diagnóstico por Imagen de Elasticidad , Femenino , Humanos , Hígado/patología , Masculino , Enfermedad del Hígado Graso no Alcohólico/sangre , Enfermedad del Hígado Graso no Alcohólico/complicaciones , Enfermedad del Hígado Graso no Alcohólico/diagnóstico por imagen , Obesidad Infantil/complicaciones , Índice de Severidad de la Enfermedad , Ultrasonografía
17.
Anesth Essays Res ; 12(2): 452-458, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29962615

RESUMEN

BACKGROUND: Adductor canal blocks (ACBs) have become a popular technique for postoperative pain control in total knee arthroplasty patients. Proximal and distal ACB have been compared previously, but important postoperative outcomes have yet to be assessed. AIMS: The primary objective of this study is to compare postoperative analgesia between proximal and distal ACB. Secondary outcomes include functional mobility, length of stay (LOS), and adverse events. SETTINGS AND DESIGN: This study was a single-center, assessor-blinded, randomized trial. SUBJECTS AND METHODS: Fifty-seven patients were randomly assigned to receive a proximal (n = 28) or distal (n = 29) ACB. A 20 mL bolus of 5 mg/mL ropivacaine was injected at the respective location followed by 2.0 mg/mL ropivacaine infusion for 24 h. STATISTICAL ANALYSIS: The primary outcome was intra- and postoperative 24-h opioid consumption in intravenous (IV) morphine equivalents. Secondary outcomes include percentage change in timed "Up and Go" (TUG) times, LOS, and average postoperative pain scores. Continuous variables were compared using Student's t-test. RESULTS: The mean (±standard deviation) 24-h intra-and postoperative opioid consumption showed no difference between the proximal and distal groups (39.72 ± 23.6 and 41.28 ± 19.6 mg IV morphine equivalents, respectively, P = 0.793). There was also no significant difference in the median [minimum, maximum] percentage change in TUG times relative to preoperative performance comparing proximal and distal ACB (334.0 [131, 1084] %-change and 458.5 [169, 1696] %-change, respectively, P = 0.130). In addition, there were no differences in postoperative pain scores or LOS. CONCLUSIONS: ACB performed at either proximal or distal locations shows no difference in postoperative pain measured by opioid consumption or pain scores. Better TUG performance seen in the proximal group was not statistically significant but might represent a clinically important difference in functional mobility.

18.
Oncol Nurs Forum ; 45(4): 496-507, 2018 07 02.
Artículo en Inglés | MEDLINE | ID: mdl-29947356

RESUMEN

OBJECTIVES: To assess the prevalence of supportive care needs (SCNs) and distress and to describe relationships among these and patient characteristics for ethnically diverse older adults with advanced or recurrent cancer. SAMPLE & SETTING: Cross-sectional survey in five outpatient oncology clinics in an urban academic medical center involving 100 participants receiving cancer care in an economically challenged community. METHODS & VARIABLES: The supportive care framework for cancer care guided this study, and participants completed the SCN Survey Short Form 34 and the Distress Thermometer. Study variables are cancer diagnosis, gender, helping to raise children, number of comorbid diseases, race or ethnicity, treatment status, and zip code. RESULTS: Clinically meaningful distress was found in about a third of patients. Distress was not affected by race or ethnicity. Many ethnically diverse older patients with advanced or recurrent cancer report distress and SCNs; those with high distress are more likely to report multiple SCNs. IMPLICATIONS FOR NURSING: Nursing assessment of patient SCNs and distress is integral to establishing individualized patient-centered care plans and to delivering optimal care.


Asunto(s)
Enfermedad Crónica/psicología , Etnicidad/psicología , Etnicidad/estadística & datos numéricos , Evaluación de Necesidades/estadística & datos numéricos , Neoplasias/psicología , Apoyo Social , Estrés Psicológico , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Persona de Mediana Edad , Encuestas y Cuestionarios , Estados Unidos
19.
Support Care Cancer ; 26(9): 3307-3313, 2018 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-29671062

RESUMEN

OBJECTIVE: To analyze nutritional factors and compliance with dietary recommendations for associations with overall survival (OS) and progression-free survival (PFS) in patients receiving definitive RT for laryngeal and oropharyngeal cancers. MATERIALS/METHODS: We identified 352 patients with non-metastatic laryngeal (146) and oropharyngeal (206) cancer treated with definitive RT between 2004 and 2013. Disease and patient characteristics, treatment information, sarcopenia based on muscle areas at L3 level on CT, compliance with the nutritional program, and clinical outcomes data were tabulated. Descriptive statistics, Kaplan-Meier survival analysis, and log rank tests were performed, and Cox regression models were used to examine predictors of OS and PFS. RESULTS: The median follow-up for the entire cohort was 22.86 months. The actuarial rates for OS were 91, 86, and 73% at years 1, 2, and 5, respectively. Of patients with abdominal CT prior to starting RT, 70.9% (112/158) were sarcopenic with a median muscle mass index of 48.2 (range 30.4-70.9) for males and 35.9 (range 24.6-53.2) for females. The majority (85.8%) of patients met with a dietitian during their course of RT and 62.6% of these patients were compliant with the nutritional program. Compliance with the nutritional program resulted in 27% (HR 0.73, 95% CI 0.43-1.26) protection from death (did not reach significance) and 31% (HR 0.69, 95% CI 0.50-0.94) significant protection from disease progression. Higher pretreatment BMI was associated with a lower risk of death (HR 0.94, 95% CI 0.90-0.99) and disease progression (HR 0.96, 95% CI 0.93-0.99). CONCLUSION: Laryngeal and oropharyngeal cancer patients treated with definitive RT who are compliant with regular dietetic counseling and contact appear to have improved outcomes. TRIAL REGISTRATION: Not applicable.


Asunto(s)
Cooperación del Paciente/psicología , Carcinoma de Células Escamosas de Cabeza y Cuello/dietoterapia , Carcinoma de Células Escamosas de Cabeza y Cuello/radioterapia , Dieta , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Carcinoma de Células Escamosas de Cabeza y Cuello/patología
20.
Yale J Biol Med ; 89(3): 277-284, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27698612

RESUMEN

Human body sites represent ecological niches for microorganisms, each providing variations in microbial exposure, nutrient availability, microbial competition, and host immunological responses. In this study, we investigated the oral, anal, and cervical microbiomes from the same 20 sexually active adolescent females, using culture-independent, next-generation sequencing. DNA from each sample was amplified for the bacterial 16S rRNA gene and sequenced on an Illumina platform using paired-end reads. Across the three anatomical niches, we found significant differences in bacterial community composition and diversity. Overall anal samples were dominated with Prevotella and Bacteriodes, oral samples with Streptococcus and Prevotella, and cervical samples with Lactobacillus. The microbiomes of a few cervical samples clustered with anal samples in weighted principal coordinate analyses, due in part to a higher proportion of Prevotella in those samples. Additionally, cervical samples had the lowest alpha diversity. Our results demonstrate the occurrence of distinct microbial communities across body sites within the same individual.


Asunto(s)
Canal Anal/microbiología , Moco del Cuello Uterino/microbiología , Boca/microbiología , Adolescente , Adulto , Niño , Biología Computacional , Femenino , Humanos , Microbiota/fisiología , Análisis de Secuencia de ADN , Adulto Joven
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