Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 99
Filtrar
1.
Artigo em Inglês | MEDLINE | ID: mdl-33164065

RESUMO

OBJECTIVE: Real-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a scoping review of database-specific RWD applications within clinical trial contexts, synthesizing prominent uses and themes. MATERIALS AND METHODS: Querying 3 biomedical literature databases, research articles using electronic health records, administrative claims databases, or clinical registries either within a clinical trial or in tandem with methodology related to clinical trials were included. Articles were required to use at least 1 US RWD source. All abstract screening, full-text screening, and data extraction was performed by 1 reviewer. Two reviewers independently verified all decisions. RESULTS: Of 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims, and 26 used registries. Our synthesis was driven by the general life cycle of a clinical trial, culminating into 3 major themes: trial process tasks (51 articles); dissemination strategies (6); and generalizability assessments (34). Despite a diverse set of diseases studied, <10% of trials using RWD for trial process tasks evaluated medications or procedures (5/51). All articles highlighted data-related challenges, such as missing values. DISCUSSION: Database-specific RWD have been occasionally leveraged for various clinical trial tasks. We observed underuse of RWD within conducted medication or procedure trials, though it is subject to the confounder of implicit report of RWD use. CONCLUSION: Enhanced incorporation of RWD should be further explored for medication or procedure trials, including better understanding of how to handle related data quality issues to facilitate RWD use.

2.
JAMA Netw Open ; 3(11): e2025134, 2020 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-33175177

RESUMO

Importance: Adults who belong to racial/ethnic minority groups are more likely than White adults to receive a diagnosis of chronic disease in the United States. Objective: To evaluate which health indicators have improved or become worse among Black and Hispanic middle-aged and older adults since the Minority Health and Health Disparities Research and Education Act of 2000. Design, Setting, and Participants: In this repeated cross-sectional study, a total of 4 856 326 records were extracted from the Behavioral Risk Factor Surveillance System from January 1999 through December 2018 of persons who self-identified as Black (non-Hispanic), Hispanic (non-White), or White and who were 45 years or older. Exposure: The 1999 legislation to reduce racial/ethnic health disparities. Main Outcomes and Measures: Poor health indicators and disparities including major chronic diseases, physical inactivity, uninsured status, and overall poor health. Results: Among the 4 856 326 participants (2 958 041 [60.9%] women; mean [SD] age, 60.4 [11.8] years), Black adults showed an overall decrease indicating improvement in uninsured status (ß = -0.40%; P < .001) and physical inactivity (ß = -0.29%; P < .001), while they showed an overall increase indicating deterioration in hypertension (ß = 0.88%; P < .001), diabetes (ß = 0.52%; P < .001), asthma (ß = 0.25%; P < .001), and stroke (ß = 0.15%; P < .001) during the last 20 years. The Black-White gap (ie, the change in ß between groups) showed improvement (2 trend lines converging) in uninsured status (-0.20%; P < .001) and physical inactivity (-0.29%; P < .001), while the Black-White gap worsened (2 trend lines diverging) in diabetes (0.14%; P < .001), hypertension (0.15%; P < .001), coronary heart disease (0.07%; P < .001), stroke (0.07%; P < .001), and asthma (0.11%; P < .001). Hispanic adults showed improvement in physical inactivity (ß = -0.28%; P = .02) and perceived poor health (ß = -0.22%; P = .001), while they showed overall deterioration in hypertension (ß = 0.79%; P < .001) and diabetes (ß = 0.50%; P < .001). The Hispanic-White gap showed improvement in coronary heart disease (-0.15%; P < .001), stroke (-0.04%; P < .001), kidney disease (-0.06%; P < .001), asthma (-0.06%; P = .02), arthritis (-0.26%; P < .001), depression (-0.23%; P < .001), and physical inactivity (-0.10%; P = .001), while the Hispanic-White gap worsened in diabetes (0.15%; P < .001), hypertension (0.05%; P = .03), and uninsured status (0.09%; P < .001). Conclusions and Relevance: This study suggests that Black-White disparities increased in diabetes, hypertension, and asthma, while Hispanic-White disparities remained in diabetes, hypertension, and uninsured status.

3.
J Alzheimers Dis ; 2020 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-33164939

RESUMO

BACKGROUND: Mid-life obesity is associated with cognitive impairment, though the relationship for late-life obesity is equivocal, and may depend on the anthropometric measure. OBJECTIVE: We examined the relationship between adiposity and cognition across age categories, cognitive domains, and by measures of obesity in a multi-ethnic population-based cohort. METHODS: The study included 1,179 Northern Manhattan Study participants with obesity measures at baseline (44% overweight, 30% obese), an initial neuropsychological assessment conducted within 7 years (mean age = 70), and a second cognitive assessment conducted on average 6 years later. Z-scores were derived for cognitive domains (episodic and semantic memory, executive function, processing speed) and averaged to calculate global cognition. Body mass index (BMI) and waist:hip ratio (WHR) were examined in relation to cognitive performance and change over time, stratified by age, using linear regression models adjusting for vascular risk factors. RESULTS: Among those age<65 years at baseline, greater WHR was associated with worse global cognitive performance at initial assessment and directly associated with decline in performance between assessments. The association with initial performance was strongest for non-Hispanic Whites (beta = -0.155/standard deviation, p = 0.04), followed by non-Hispanic Black/African Americans (beta = -0.079/standard deviation, p = 0.07), and Hispanics (beta = -0.055/standard deviation, p = 0.03). The associations were most apparent for the domains of processing speed and executive function. There was no association for BMI among those <65 years. Among those age ≥65, there was no association for BMI or WHR with cognitive performance at initial assessment nor decline over time. CONCLUSION: Our results support the detrimental effect of mid-life rather than later life obesity, particularly abdominal adiposity, on cognitive impairment and decline.

4.
Neurol Genet ; 6(4): e462, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32754642

RESUMO

Objective: We investigated whether APOE ϵ4 is an effect modifier of the association between infectious burden (IB) and poor cognition in a multiethnic cohort, the Northern Manhattan Study. Methods: IB was assessed by a quantitative weighted index of exposure to common pathogens associated with vascular risk, infectious burden index (IBI), and by serology for individual infections. Cognition was assessed by completion of the Mini-Mental State Examination at baseline and a full neuropsychological test battery after a median follow-up of approximately 6 years. Adjusted linear and logistic regressions estimated the association between IBI and cognition, with a term included for the interaction between APOE ϵ4 and IBI. Results: Among those with full neuropsychological test results (n = 569), there were interactions between IBI and APOE ϵ4 (p = 0.07) and herpes simplex virus 1 (HSV-1) and APOE ϵ4 (p = 0.02) for processing speed. IBI was associated with slower processing speed among non-ϵ4 carriers (ß = -0.08 per SD change in IBI, 95% confidence interval [CI] -0.16 to -0.01), but not among APOE ϵ4 carriers (ß = 0.06 per SD change in IBI, 95% CI -0.08 to 0.19). HSV-1 positivity was associated with slower processing speed among non-ϵ4 carriers (ß = -0.24, 95% CI -0.45 to -0.03), but not among APOE ϵ4 carriers (ß = 0.27, 95% CI -0.09 to 0.64). Conclusions: Potential effect modification by the APOE ϵ4 allele on the relationship of infection, and particularly viral infection, to cognitive processing speed warrants further investigation.

5.
Brain Imaging Behav ; 2020 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32740887

RESUMO

High dimensional neuroimaging datasets and machine learning have been used to estimate and predict domain-specific cognition, but comparisons with simpler models composed of easy-to-measure variables are limited. Regularization methods in particular may help identify regions-of-interest related to domain-specific cognition. Using data from the Northern Manhattan Study, a cohort study of mostly Hispanic older adults, we compared three models estimating domain-specific cognitive performance: sociodemographics and APOE ε4 allele status (basic model), the basic model and MRI markers, and a model with only MRI markers. We used several machine learning methods to fit our regression models: elastic net, support vector regression, random forest, and principal components regression. Model performance was assessed with the RMSE, MAE, and R2 statistics using 5-fold cross-validation. To assess whether prediction models with imaging biomarkers were more predictive than prediction models built with randomly generated biomarkers, we refit the elastic net models using 1000 datasets with random biomarkers and compared the distribution of the RMSE and R2 in models using these random biomarkers to the RMSE and R2 from observed models. Basic models explained ~ 31-38% of the variance in domain-specific cognition. Addition of MRI markers did not improve estimation. However, elastic net models with only MRI markers performed significantly better than random MRI markers (one-sided P < .05) and yielded regions-of-interest consistent with previous literature and others not previously explored. Therefore, structural brain MRI markers may be more useful for etiological than predictive modeling.

6.
BMJ Open ; 10(6): e036056, 2020 06 07.
Artigo em Inglês | MEDLINE | ID: mdl-32513886

RESUMO

OBJECTIVE: To describe individual patient preferences for Personalised Trials and to identify factors and conditions associated with patient preferences. DESIGN: Each participant was presented with 18 conjoint questions via an online survey. Each question provided two choices of Personalised Trials that were defined by up to eight attributes, including treatment types, clinician involvement, study logistics and trial burden on a patient. SETTING: Online survey of adults with at least two common chronic conditions in the USA. PARTICIPANTS: A nationally representative sample of 501 individuals were recruited from the Chronic Illness Panel by Harris Poll Online. Participants were recruited from several sources, including emails, social media and telephone recruitment of the target population. MAIN OUTCOME MEASURES: The choice of Personalised Trial design that the participant preferred with each conjoint question. RESULTS: There was large variability in participants' preferences for the design of Personalised Trials. On average, they preferred certain attributes, such as a short time commitment and no cost. Notably, a population-level analysis correctly predicted 62% of the conjoint responses. An empirical Bayesian analysis of the conjoint data, which supported the estimation of individual-level preferences, improved the accuracy to 86%. Based on estimates of individual-level preferences, patients with chronic pain preferred a long study duration (p≤0.001). Asthma patients were less averse to participation burden in terms of data-collection frequency than patients with other conditions (p=0.002). Patients with hypertension were more cost-sensitive (p<0.001). CONCLUSION: These analyses provide a framework for elucidating individual-level preferences when implementing novel patient-centred interventions. The data showed that patient preference in Personalised Trials is highly variable, suggesting that individual differences must be accounted for when marketing Personalised Trials. These results have implications for advancing precise interventions in Personalised Trials by indicating when rigorous scientific principles, such as frequent monitoring, is feasible in a substantial subset of patients.

7.
Stat Methods Med Res ; 29(11): 3205-3217, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32368950

RESUMO

This paper presents a new model-based generalized functional clustering method for discrete longitudinal data, such as multivariate binomial and Poisson distributed data. For this purpose, we propose a multivariate functional principal component analysis (MFPCA)-based clustering procedure for a latent multivariate Gaussian process instead of the original functional data directly. The main contribution of this study is two-fold: modeling of discrete longitudinal data with the latent multivariate Gaussian process and developing of a clustering algorithm based on MFPCA coupled with the latent multivariate Gaussian process. Numerical experiments, including real data analysis and a simulation study, demonstrate the promising empirical properties of the proposed approach.

8.
Cerebrovasc Dis Extra ; 10(1): 21-27, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32289771

RESUMO

INTRODUCTION: Low cerebral blood flow can affect cognition in patients with high-grade asymptomatic internal carotid artery stenosis. Current clinical algorithms use stroke risk to determine which patients should undergo revascularization without considering cognitive decline. Although correlations between low-flow and cognitive impairment have been reported, it is not known whether a threshold exists below which such a correlation expresses itself. Such information would be critical in treatment decisions about whether to intervene in patients with high-grade carotid artery stenosis who are at risk for cognitive decline. OBJECTIVE: To determine how reduced blood flow correlates with lower cognitive scores. METHODS: Patients with ≥80% unilateral internal carotid artery stenosis with no history of stroke were recruited from inpatient and outpatient practices at a single, large, comprehensive stroke center. Patients underwent bilateral insonation of middle cerebral arteries with standard 2-Hz probes over the temporal windows with transcranial Doppler. Cognitive assessments were performed by an experienced neuropsychologist using a cognitive battery comprising 14 standardized tests with normative samples grouped by age. Z-scores were generated for each test and averaged to obtain a composite Z-score for each patient. Multivariable linear regression examined associations between mean flow velocity (MFV) and composite Z-score, adjusting for age, education, and depression. The Davies test was used to determine if there was a breakpoint for a non-zero difference in slope of a segmented relationship over the range of composite Z-score values. RESULTS: Forty-two patients with unilateral high-grade internal carotid artery stenosis without stroke were enrolled (26 males, age = 74 ± 9 years, education = 16 ± 3 years). Average composite Z-score was -0.31 SD below the age-specific normative mean (range -2.8 to +1.2 SD). In linear regression adjusted for age, education, and depression, MFV correlated with cognitive Z-score (ß = 0.308, p = 0.043). A single breakpoint in the range of composite Z-scores was identified at 45 cm/s. For MFV <45 cm/s, Z-score decreased 0.05 SD per cm/s MFV (95% CI: 0.01-0.10). For MFV >45 cm/s, Z-score change was nonsignificant (95% CI: -0.07 to 0.05). CONCLUSIONS: In high-grade, asymptomatic carotid artery stenosis, cognitive impairment correlated linearly with lower flow in the hemisphere fed by the occluded internal carotid artery, but only below a threshold of MFV = 45 cm/s. Identifying a hemodynamic threshold for cognitive decline using a simple, noninvasive method may influence revascularization decision-making in otherwise "asymptomatic" carotid disease.


Assuntos
Estenose das Carótidas/diagnóstico por imagem , Circulação Cerebrovascular , Cognição , Disfunção Cognitiva/diagnóstico por imagem , Hemodinâmica , Artéria Cerebral Média/diagnóstico por imagem , Ultrassonografia Doppler Transcraniana , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças Assintomáticas , Velocidade do Fluxo Sanguíneo , Estenose das Carótidas/complicações , Estenose das Carótidas/fisiopatologia , Estenose das Carótidas/psicologia , Disfunção Cognitiva/etiologia , Disfunção Cognitiva/fisiopatologia , Disfunção Cognitiva/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Artéria Cerebral Média/fisiopatologia , Valor Preditivo dos Testes , Fatores de Risco , Índice de Gravidade de Doença , Adulto Jovem
9.
Biometrics ; 2020 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-32150282

RESUMO

This paper considers the clustering problem of physical step count data recorded on wearable devices. Clustering step data give an insight into an individual's activity status and further provide the groundwork for health-related policies. However, classical methods, such as K-means clustering and hierarchical clustering, are not suitable for step count data that are typically high-dimensional and zero-inflated. This paper presents a new clustering method for step data based on a novel combination of ensemble clustering and binning. We first construct multiple sets of binned data by changing the size and starting position of the bin, and then merge the clustering results from the binned data using a voting method. The advantage of binning, as a critical component, is that it substantially reduces the dimension of the original data while preserving the essential characteristics of the data. As a result, combining clustering results from multiple binned data can provide an improved clustering result that reflects both local and global structures of the data. Simulation studies and real data analysis were carried out to evaluate the empirical performance of the proposed method and demonstrate its general utility.

10.
J Cancer Surviv ; 14(3): 393-403, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32130627

RESUMO

PURPOSE: To identify distinct trajectories of total moderate-to-vigorous physical activity (MVPA) and sedentary behavior following a breast cancer diagnosis and their correlates. METHODS: The analysis examined 3000 female breast cancer survivors within Kaiser Permanente Northern California between 2006 and 2013. Self-reported time spent on total MVPA and sedentary behaviors were assessed at baseline (mean = 1.8 months post-diagnosis) and at 6 and 24 months follow up. Trajectory groups were identified using group-based trajectory modeling and K-means for longitudinal data analysis. Trajectory groups were named by baseline activity level (high, medium, or low) and direction of change (increaser, decreaser, or maintainer). RESULTS: Trajectory analyses identified three MVPA trajectories [high decreaser (7%), medium decreaser (35%), low maintainer (58%)] and four sedentary behavior trajectories [high maintainer (18%), high decreaser (27%), low increaser (24%), and low maintainer (31%)]. Women with higher education (ORs: 1.63-4.37), income (OR: 1.37), dispositional optimism (ORs: 1.60-1.86), and social support (OR: 1.33) were more likely to be high or medium decreasers of MVPA (all P < 0.05). High maintainers and high decreasers of sedentary behavior were more likely to have higher education (OR: 1.84) and social support (ORs: 1.42-1.86), but lower income (OR: 0.66; all P < 0.05). CONCLUSIONS: In the 24 months following breast cancer diagnosis, 42% of survivors decreased MVPA and 73% maintained or increased time on sedentary behavior. Socioeconomic status and stress coping at diagnosis predicted subsequent PA trajectory. IMPLICATIONS FOR CANCER SURVIVORS: It is important to prioritize exercise intervention and counseling during early stage of breast cancer survivorship, especially in survivors who are at high risk of becoming physically inactive post-diagnosis.


Assuntos
Neoplasias da Mama/terapia , Exercício Físico/fisiologia , Comportamento Sedentário , Idoso , Neoplasias da Mama/diagnóstico , Feminino , Humanos , Pessoa de Meia-Idade
11.
Stroke ; 51(4): 1064-1069, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32078475

RESUMO

Background and Purpose- An excess incidence of strokes among blacks versus whites has been shown, but data on disparities related to Hispanic ethnicity remain limited. This study examines race/ethnic differences in stroke incidence in the multiethnic, largely Caribbean Hispanic, NOMAS (Northern Manhattan Study), and whether disparities vary by age. Methods- The study population included participants in the prospective population-based NOMAS, followed for a mean of 14±7 years. Multivariable-adjusted Cox proportional hazards models were constructed to estimate the association between race/ethnicity and incident stroke of any subtype and ischemic stroke, stratified by age. Results- Among 3298 participants (mean baseline age 69±10 years, 37% men, 24% black, 21% white, 52% Hispanic), 460 incident strokes accrued (400 ischemic, 43 intracerebral hemorrhage, 9 subarachnoid hemorrhage). The most common ischemic subtype was cardioembolic, followed by lacunar infarcts, then cryptogenic. The greatest incidence rate was observed in blacks (13/1000 person-years), followed by Hispanics (10/1000 person-years), and lowest in whites (9/1000 person-years), and this order was observed for crude incidence rates until age 75. By age 85, the greatest incidence rate was in Hispanics. Blacks had an increased risk of stroke versus whites overall in multivariable models that included sociodemographics (hazard ratio, 1.51 [95% CI, 1.13-2.02]), and stratified analyses showed that this disparity was driven by women of age ≥70. The increased rate of stroke among Hispanics (age/sex-adjusted hazard ratio, 1.48 [95% CI, 1.13-1.93]) was largely explained by education and insurance status (a proxy for socieoeconomic status; hazard ratio after further adjusting for these variables, 1.17 [95% CI, 0.85-1.62]) but remained significant for women age ≥70. Conclusions- This study provides novel data regarding the increased stroke risk among Caribbean Hispanics in this elderly population. Results highlight the need to create culturally tailored campaigns to reach black and Hispanic populations to reduce race/ethnic stroke disparities and support the important role of low socioeconomic status in driving an elevated risk among Caribbean Hispanics.


Assuntos
Grupo com Ancestrais do Continente Africano/etnologia , Isquemia Encefálica/etnologia , Grupo com Ancestrais do Continente Europeu/etnologia , Disparidades em Assistência à Saúde/etnologia , Hispano-Americanos , Acidente Vascular Cerebral/etnologia , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/economia , Estudos de Coortes , Grupos de Populações Continentais/etnologia , Grupos Étnicos , Feminino , Seguimentos , Disparidades em Assistência à Saúde/economia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Cidade de Nova Iorque/etnologia , Estudos Prospectivos , Fatores de Risco , Classe Social , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/economia
12.
J Gerontol A Biol Sci Med Sci ; 75(8): 1508-1515, 2020 Jul 13.
Artigo em Inglês | MEDLINE | ID: mdl-31944231

RESUMO

BACKGROUND: How cerebrovascular disease and neurodegeneration affect each other to impact cognition is not yet known. We aimed to test whether Alzheimer's disease-signature (AD) cortical thickness mediates the association between cholinergic white matter lesion load and change in domain-specific cognition. METHODS: Clinically stroke-free participants from the Northern Manhattan Study with both regional white matter hyperintensity volume (WMHV) and gray matter measurements were included (N = 894). Tract-specific WMHVs were quantified through FSL using the Johns Hopkins University white matter tract atlas. We used Freesurfer 5.1 to estimate regional cortical thickness. We fit structural equation models, including multiple indicator latent change score models, to examine associations between white matter hyperintensity volume (WMHV) in cholinergic tracts, AD-signature region cortical thickness (CT), and domain-specific cognition. RESULTS: Our sample (N = 894) had a mean (SD) age = 70 (9) years, years of education = 10 (5), 63% women, and 67% Hispanics/Latinos. Greater cholinergic WMHV was significantly related to worse processing speed at baseline (standardized ß = -0.17, SE = 0.05, p = .001) and over time (standardized ß = -0.28, SE = 0.09, p = .003), with a significant indirect effect of AD-signature region CT (baseline: standardized ß = -0.02, SE = 0.01, p = .023; change: standardized ß = -0.03, SE = 0.02, p = .040). CONCLUSIONS: Cholinergic tract WMHV is associated with worse processing speed, both directly and indirectly through its effect on AD-signature region CT.

13.
Stroke ; 51(2): 372-378, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31910743

RESUMO

Background and Purpose- Few studies have examined the separate contributions of systolic blood pressure and diastolic blood pressures (DBP) on subclinical cerebrovascular disease, especially using the 2017 American College of Cardiology/American Heart Association Blood Pressure Guidelines. Furthermore, associations with region-specific white matter hyperintensity volume (WMHV) are underexplored. Methods- Using data from the NOMAS (Northern Manhattan Study), a prospective cohort study of stroke risk and cognitive aging, we examined associations between systolic blood pressure and DBP, defined by the 2017 American College of Cardiology/American Heart Association guidelines, with regional WMHV. We used a linear mixed model approach to account for the correlated nature of regional brain measures. Results- The analytic sample (N=1205; mean age 64±8 years) consisted of 61% women and 66% Hispanics/Latinos. DBP levels were significantly related to WMHV differentially across regions (P for interaction<0.05). Relative to those with DBP 90+ mm Hg, participants with DBP <80 mm Hg had 13% lower WMHV in the frontal lobe (95% CI, -21% to -3%), 11% lower WMHV in the parietal lobe (95% CI, -19% to -1%), 22% lower WMHV in the anterior periventricular region (95% CI, -30% to -14%), and 16% lower WMHV in the posterior periventricular region (95% CI, -24% to -6%). Participants with DBP 80 to 89 mm Hg also exhibited about 12% (95% CI, -20% to -3%) lower WMHV in the anterior periventricular region and 9% (95% CI, -18% to -0.4%) lower WMHV in the posterior periventricular region, relative to participants with DBP 90≥ mm Hg. Post hoc pairwise t tests showed that estimates for periventricular WMHV were significantly different from estimates for temporal WMHV (Holms stepdown-adjusted P<0.05). Systolic blood pressure was not strongly related to regional WMHV. Conclusions- Lower DBP levels, defined by the 2017 American College of Cardiology/American Heart Association guidelines, were related to lower white matter lesion load, especially in the periventricular regions relative to the temporal region.


Assuntos
Pressão Sanguínea , Diástole , Hipertensão/fisiopatologia , Substância Branca/diagnóstico por imagem , Idoso , Pressão Arterial , Encéfalo/diagnóstico por imagem , Estudos de Coortes , Feminino , Lobo Frontal/diagnóstico por imagem , Humanos , Modelos Lineares , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Tamanho do Órgão , Lobo Parietal/diagnóstico por imagem , Estudos Prospectivos , Sístole , Lobo Temporal/diagnóstico por imagem , Substância Branca/patologia
14.
Neuromodulation ; 23(3): 366-372, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31667947

RESUMO

OBJECTIVE: Repetitive transcranial magnetic stimulation (rTMS) can cause potentially useful changes in brain functional connectivity (FC), but the number of treatment sessions required is unknown. We applied the continual reassessment method (CRM), a Bayesian, adaptive, dose-finding procedure to a rTMS paradigm in an attempt to answer this question. MATERIALS AND METHODS: The sample size was predetermined at 15 subjects and the cohort size was set with three individuals (i.e., five total cohorts). In a series of consecutive daily sessions, we delivered rTMS to the left posterior parietal cortex and measured resting-state FC with fMRI in a predefined hippocampal network in the left hemisphere. The session number for each successive cohort was determined by the CRM algorithm. We set a response criterion of a 0.028 change in FC between the hippocampus and the parietal cortex, which was equal to the increase seen in 87.5% of participants in a previous study using five sessions. RESULTS: A ≥criterion change was observed in 9 of 15 participants. The CRM indicated that greater than four sessions are required to produce the criterion change reliably in future studies. CONCLUSIONS: The CRM can be adapted for rTMS dose finding when a reliable outcome measure, such as FC, is available. The minimum effective dose needed to produce a criterion increase in FC in our hippocampal network of interest at 87.5% efficacy was estimated to be greater than four sessions. This study is the first demonstration of a Bayesian, adaptive method to explore a rTMS parameter.

15.
Breast Cancer Res Treat ; 179(1): 229-240, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31599394

RESUMO

PURPOSE: To identify distinct diet trajectories after breast cancer (BC) diagnosis, and to examine the characteristics associated with diet trajectories. METHODS: We analyzed 2865 Pathways Study participants who completed ≥ 2 food frequency questionnaires at the time of BC diagnosis (baseline), and at 6 and 24 months after baseline. Trajectory groups of fruit and vegetable (F/V) intake, % calories from dietary fat, and alcohol intake over 24 months were identified using group-based trajectory modeling. Associations between diet trajectories and sociodemographic, psychosocial, and clinical factors were analyzed using multinomial logistic regression. RESULTS: Analyses identified 3 F/V trajectory groups, 4 dietary fat groups, and 3 alcohol groups. All 3 F/V trajectory groups reported slightly increased F/V intake post-diagnosis (mean increase = 0.2-0.5 serving/day), while 2 groups (48% of participants) persistently consumed < 4 servings/day of F/V. Dietary fat intake did not change post-diagnosis, with 45% of survivors maintaining a high-fat diet (> 40% of calories from fat). While most survivors consumed < 1 drink/day of alcohol at all times, 21% of survivors had 1.4-3.0 drinks/day at baseline and temporarily decreased to 0.1-0.5 drinks/day at 6 months. In multivariable analysis, diet trajectory groups were significantly associated with education (ORs: 1.93-2.49), income (ORs: 1.32-2.57), optimism (ORs: 1.93-2.49), social support (OR = 1.82), and changes in physical well-being (ORs: 0.58-0.61) and neuropathy symptoms after diagnosis (ORs: 1.29-1.66). CONCLUSIONS: Pathways Study participants reported slightly increasing F/V and decreasing alcohol intake after BC diagnosis. Nearly half of survivors consumed insufficient F/V and excessive dietary fat. It is important to prioritize nutrition counseling and education in BC survivors.


Assuntos
Consumo de Bebidas Alcoólicas/epidemiologia , Neoplasias da Mama/diagnóstico , Gorduras na Dieta/administração & dosagem , Fibras na Dieta/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/psicologia , Feminino , Frutas/química , Comportamentos Relacionados com a Saúde , Humanos , Pessoa de Meia-Idade , Verduras/química
16.
JAMA Intern Med ; 2019 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-31633746

RESUMO

Importance: Patients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials. Objective: To determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care. Design, Setting, and Participants: A 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis. Interventions: Patients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500). Main Outcomes and Measures: The primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records. Results: A total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, -0.06 [0.20]; screen and notify, -0.06 [0.20]; no screen, -0.06 [0.18]; P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days; P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups. Conclusions and Relevance: In patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms. Trial Registration: ClinicalTrials.gov identifier: NCT01993017.

17.
Contemp Clin Trials ; 85: 105830, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31470107

RESUMO

This article proposes a method to overcome limitations in current methods that address multiple comparisons of adaptive interventions embedded in sequential multiple assignment randomized trial (SMART) designs. Because a SMART typically consists of numerous adaptive interventions, inferential procedures based on pairwise comparisons of all may suffer a substantial loss in power after accounting for multiplicity. Meanwhile, traditional methods for multiplicity adjustments in comparing non-adaptive interventions require prior knowledge of correlation structures, which can be difficult to postulate when analyzing SMART data of adaptive interventions. To address the multiplicity issue, we propose a likelihood-based omnibus test that compares all adaptive interventions simultaneously, and apply it as a gate-keeping test for further decision making. Specifically, we consider a selection procedure that selects the adaptive intervention with the best observed outcome only when the proposed omnibus test reaches a pre-specified significance level, so as to control false positive selection. We derive the asymptotic distribution of the test statistic on which a sample size formula is based. Our simulation study confirms that the asymptotic approximation is accurate with a moderate sample size, and shows that the proposed test outperforms existing multiple comparison procedures in terms of statistical power. The simulation results also suggest that our selection procedure achieves a high probability of selecting a superior adaptive intervention. The application of the proposed method is illustrated with a real dataset from a depression management study.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Interpretação Estatística de Dados , Humanos , Funções Verossimilhança , Modelos Estatísticos , Distribuição Aleatória , Projetos de Pesquisa , Resultado do Tratamento
18.
Contemp Clin Trials ; 84: 105826, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31419605

RESUMO

BACKGROUND: Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients. METHODS: The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2-12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months. RESULTS: A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms. CONCLUSIONS: Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01993017).


Assuntos
Síndrome Coronariana Aguda/complicações , Depressão/diagnóstico , Depressão/etiologia , Programas de Rastreamento/métodos , Atenção Primária à Saúde/métodos , Síndrome Coronariana Aguda/psicologia , Fatores Etários , Idoso , Algoritmos , Antidepressivos/uso terapêutico , Análise Custo-Benefício , Aconselhamento/métodos , Depressão/terapia , Feminino , Nível de Saúde , Humanos , Masculino , Programas de Rastreamento/economia , Saúde Mental , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Atenção Primária à Saúde/economia , Qualidade de Vida , Encaminhamento e Consulta , Fatores Sexuais , Método Simples-Cego , Fatores Socioeconômicos
19.
Neurology ; 93(8): e791-e803, 2019 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-31341005

RESUMO

OBJECTIVE: To examine associations between measures of obesity in middle to early-old age with later-life MRI markers of brain aging. METHODS: We analyzed data from the Northern Manhattan MRI Sub-Study (n = 1,289). Our exposures of interest were body mass index (BMI), waist circumference (WC), waist-to-hip ratio, and plasma adiponectin levels. Our outcomes of interest were total cerebral volume (TCV), cortical thickness, white matter hyperintensity volume (WMHV), and subclinical brain infarcts (SBI). Using multivariable linear and logistic regression models adjusted for sociodemographics, health behaviors, and vascular risk factors, we estimated ß coefficients (or odds ratios) and 95% confidence intervals (CIs) and tested interactions with age, sex, and race/ethnicity. RESULTS: On average at baseline, participants were aged 64 years and had 10 years of education; 60% were women and 66% were Caribbean Hispanic. The mean (SD) time lag between baseline and MRI was 6 (3) years. Greater BMI and WC were significantly associated with thinner cortices (BMI ß [95% CI] -0.089 [-0.153, -0.025], WC ß [95% CI] -0.103 [-0.169, -0.037]) in fully adjusted models. Similarly, compared to those with BMI <25, obese participants (BMI ≥30) exhibited smaller cortical thickness (ß [95% CI] -0.207 [-0.374, -0.041]). These associations were particularly evident for those aged <65 years. Similar but weaker associations were observed for TCV. Most associations with WMHV and SBI did not reach statistical significance. CONCLUSIONS: Adiposity in early-old age is related to reduced global gray matter later in life in this diverse sample. Future studies are warranted to elucidate causal relationships and explore region-specific associations.


Assuntos
Adiponectina/sangue , Envelhecimento/sangue , Envelhecimento/patologia , Encéfalo/patologia , Obesidade/sangue , Obesidade/patologia , Idoso , Atrofia/patologia , Biomarcadores/sangue , Tamanho Corporal , Infarto Encefálico/complicações , Infarto Encefálico/patologia , Feminino , Humanos , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Neuroimagem , Obesidade/complicações , Substância Branca/patologia
20.
J Am Heart Assoc ; 8(13): e010406, 2019 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-31238767

RESUMO

Background Previous cross-sectional studies have shown conflicting results regarding the effects of television viewing and occupational sitting on cardiovascular disease ( CVD ) risk factors. The purpose of this study was to compare the association of both television viewing and occupational sitting with CVD events and all-cause mortality in blacks. Methods and Results Participants included 3592 individuals enrolled in the Jackson Heart Study, a community-based study of blacks residing in Jackson, Mississippi. Television viewing (<2, 2-4, and >4 h/day) and occupational sitting (never/seldom, sometimes, often/always) were self-reported. Over a median follow-up of 8.4 years, there were 129 CVD events and 205 deaths. The highest category of television viewing (>4 h/day) was associated with a greater risk for a composite CVD events/all-cause mortality end point compared with the lowest category (<2 h/day; hazard ratio, 1.49; 95% CI , 1.13-1.97). In contrast, the highest category of occupational sitting (often/always) was not associated with risk for a composite CVD events/all-cause mortality end point compared with the lowest category (never/seldom; hazard ratio, 0.90; 95% CI , 0.69-1.18). Moderate-to-vigorous physical activity moderated the association of television viewing with CVD events/all-cause mortality such that television viewing was not associated with greater risk among those with high moderate-to-vigorous physical activity levels. Conclusions Television viewing was associated with greater risk of CVD events and all-cause mortality, while occupational sitting had no association with these outcomes. These findings suggest that minimizing television viewing may be more effective for reducing CVD and mortality risk in blacks compared with reducing occupational sedentary behavior.


Assuntos
Afro-Americanos , Doença das Coronárias/epidemiologia , Mortalidade , Ocupações/estatística & dados numéricos , Comportamento Sedentário , Acidente Vascular Cerebral/epidemiologia , Televisão/estatística & dados numéricos , Adulto , Doenças Cardiovasculares/epidemiologia , Causas de Morte , Exercício Físico , Feminino , Humanos , Atividades de Lazer , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Fatores de Risco , Autorrelato , Fatores de Tempo
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA