RESUMO
INTRODUCTION AND OBJECTIVES: The prevalence of alcohol, tobacco, and coffee use and association with liver health among North Americans with Chronic Hepatitis B (CHB) infection has not been well described. MATERIALS AND METHODS: The Hepatitis B Research Network includes an observational study of untreated CHB adults enrolled at 21 sites in the United States and Canada. Alcohol use was categorized as none, moderate, and at-risk based on the definition from the National Institute on Alcohol Abuse and Alcoholism; tobacco use as never, current and former; coffee use as none, 1-2 cups/day, and ≥3 cups/day. Linear regression and linear mixed models were used to associate lifestyle behaviors with ALT and FIB-4 values. RESULTS: 1330 participants met eligibility: 53% males, 71% Asian and the median age was 42 years (IQR: 34-52). Median ALT was 33U/L (IQR: 22-50), 37% had HBV DNA <103IU/mL, 71% were HBeAg negative, and 65% had a FIB-4 <1.45. At baseline, 8% of participants were at-risk alcohol drinkers, 11% were current smokers and 92% drank <3 cups of coffee/day. Current tobacco and 'at-risk' alcohol use, were significantly associated with elevated ALT levels in univariable analyses, however, these associations were not statistically significant when controlling for sociodemographic and HBV characteristics. CONCLUSIONS: In this large diverse cohort of untreated CHB participants, at-risk alcohol use, current tobacco use and limited coffee consumption did not have an association with high ALT and FIB-4 values. In contrast, significant associations were found between the frequency of these lifestyle behaviors and sociodemographic factors.
Assuntos
Consumo de Bebidas Alcoólicas/epidemiologia , Café , Hepatite B Crônica/epidemiologia , Cirrose Hepática/epidemiologia , Fumar Tabaco/epidemiologia , Adolescente , Adulto , África/etnologia , Idoso , Alanina Transaminase/sangue , Ásia/etnologia , Povo Asiático , População Negra , Canadá/epidemiologia , DNA Viral/sangue , Feminino , Antígenos E da Hepatite B/sangue , Hepatite B Crônica/sangue , Humanos , Cirrose Hepática/sangue , Masculino , Pessoa de Meia-Idade , Prevalência , Índice de Gravidade de Doença , Estados Unidos/epidemiologia , População Branca , Adulto JovemRESUMO
OBJECTIVE: To describe the methodology, challenges, and baseline characteristics of a prevention development trial entitled "Reducing Pain, Preventing Depression." METHODS: A sequential multiple assignment randomized trial (SMART) compared sequences of cognitive behavioral therapy (CBT) and physical therapy for knee pain and prevention of depression and anxiety. Participants were randomized to CBT, physical therapy, or enhanced usual care and followed for 12 months for new-episode depression or anxiety. Participants were age ≥ 60 with knee osteoarthritis and subsyndromal depression, defined as 9-item Patient Health Questionnaire (PHQ-9) score ≥1 (which included the endorsement of one of the cardinal symptoms of depression [low mood or anhedonia]) and no diagnosis of major depressive disorder per the Structured Clinical Interview for DSM-IV. Depression and anxiety severity and characterization of new episodes were assessed with the PHQ-9, Generalized Anxiety Disorder-7, and the PRIME-MD. Knee pain was characterized with the Western Ontario McMaster Arthritis Index. Response was defined as at least "Very Much Better" on a Patient Global Impression of Change. RESULTS: At baseline there were 99 patients with an average age of 71; 61.62% were women and 81.8% white. The average PHQ-9 was 5.6 and average Generalized Anxiety Disorder-7, was 3.2. Most were satisfied with the interventions and study procedures. The challenges and solutions described here will also be used in a confirmatory clinical trial of efficacy. CONCLUSION: A SMART design for depression and anxiety prevention, using both CBT and physical therapy, appears to be feasible and acceptable to participants. The methodologic innovations of this project may advance the field of late-life depression and anxiety prevention.
Assuntos
Ansiedade/prevenção & controle , Terapia Cognitivo-Comportamental/métodos , Depressão/prevenção & controle , Osteoartrite do Joelho/psicologia , Dor/psicologia , Idoso , Manual Diagnóstico e Estatístico de Transtornos Mentais , Emoções , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ontário , Satisfação do Paciente , Modelos de Riscos Proporcionais , Escalas de Graduação Psiquiátrica , Índice de Gravidade de Doença , Estresse PsicológicoRESUMO
Sequentially randomized designs are commonly used in biomedical research, particularly in clinical trials, to assess and compare the effects of different treatment regimes. In such designs, eligible patients are first randomized to one of the initial therapies, then patients with some intermediate response (e.g. without progressive diseases) are randomized to one of the maintenance therapies. The goal is to evaluate dynamic treatment regimes consisting of an initial therapy, the intermediate response, and a maintenance therapy. In this article, we demonstrate the use of pattern-mixture model (commonly used for analyzing missing data) for estimating the effects of treatment regimes based on familiar survival analysis techniques such as Nelson-Aalen and parametric models. Moreover, we demonstrate how to use estimates from pattern-mixture models to test for the differences across treatment regimes in a weighted log-rank setting. We investigate the properties of the proposed estimators and test in a Monte Carlo simulation study. Finally we demonstrate the methods using the long-term survival data from the high risk neuroblastoma study.