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1.
AIDS Behav ; 28(2): 421-428, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38085428

RESUMO

Social events and stressful settings can be catalysts for alcohol consumption. Motivational enhancement therapy (MET) and cognitive behavioral therapy (CBT) are widely used in alcohol interventions. We assessed how alcohol consumption varied across three types of days (positive/social, negative/stressful, and neutral) among hazardous alcohol users living with HIV in Vietnam. We further evaluated how those consumption patterns changed after two MET/CBT alcohol reduction interventions versus the standard of care (SOC). The 'combined' intervention offered 6 individual sessions and 3 group sessions; the 'brief' intervention offered 2 individual sessions and 2 phone calls. A 30-day timeline follow-back was administered at study visits, detailing daily drinks and events. Days were categorized as neutral, positive/social, or negative/stressful; negative binomial models and generalized estimating equations were used to estimate drinks consumed by type of day at baseline and 12 months. Prior to intervention, more drinks were consumed on positive/social days (5.2 drinks; 95% Confidence Interval [CI]:4.8, 5.7) than negative/stressful (1.5; 95% CI:1.3, 1.9) and neutral days (2.2; 95% CI: 1.9, 2.5). After the brief intervention, drinks consumed decreased on neutral days (ratio: 0.5: 95% CI: 0.4, 0.7). After the combined intervention, drinks consumed decreased on neutral days (ratio: 0.4; 95% CI: 0.3, 0.6), positive/social days (ratio: 0.6; 95% CI: 0.5, 0.7) and negative/stressful days (ratio: 0.3; 95% CI: 0.2, 0.6). No reductions in consumption were observed in the SOC group. Social/positive days had the highest alcohol consumption prior to intervention, and the combined intervention showed the greatest decrease in consumption on those days. CLINICAL TRIAL REGISTRATION: The study is registered at clinicaltrials.gov (NCT02720237).


Assuntos
Terapia Cognitivo-Comportamental , Infecções por HIV , Entrevista Motivacional , Humanos , Vietnã/epidemiologia , Infecções por HIV/epidemiologia , Consumo de Bebidas Alcoólicas/epidemiologia , Consumo de Bebidas Alcoólicas/psicologia
2.
AIDS Behav ; 27(6): 1972-1980, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-36409386

RESUMO

A three-armed drinking cessation trial in Vietnam found that both a brief and intensive version of an intervention effectively reduced hazardous drinking in people living with HIV. We used group-based trajectory modeling (GBTM) to assess the extent to which findings may vary by latent subgroups distinguished by their unique responses to the intervention. Using data on drinking patterns collected over the 12 months, GBTM identified five trajectory groups, three of which were suboptimal ["non-response" (17.2%); "non-sustained response" (15.7%), "slow response" (13.1%)] and two optimal ["abstinent" (36.4%); "fast response" (17.6%)]. Multinomial logistic regression was used to determine that those randomized to any intervention arm were less likely to be in a suboptimal trajectory group, even more so if randomized to the brief (vs. intensive) intervention. Older age and higher baseline coping skills protected against membership in suboptimal trajectory groups; higher scores for readiness to quit drinking were predictive of it. GBTM revealed substantial heterogeneity in participants' response to a cessation intervention and may help identify subgroups who may benefit from more specialized services within the context of the larger intervention.


Assuntos
Consumo de Bebidas Alcoólicas , Infecções por HIV , Humanos , Adulto , Consumo de Bebidas Alcoólicas/epidemiologia , População do Sudeste Asiático , Vietnã/epidemiologia , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Modelos Logísticos
3.
Neuromodulation ; 26(4): 850-860, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37287321

RESUMO

OBJECTIVES: Generalization (or near-transfer) effects of an intervention to tasks not explicitly trained are the most desirable intervention outcomes. However, they are rarely reported and even more rarely explained. One hypothesis for generalization effects is that the tasks improved share the same brain function/computation with the intervention task. We tested this hypothesis in this study of transcranial direct current stimulation (tDCS) over the left inferior frontal gyrus (IFG) that is claimed to be involved in selective semantic retrieval of information from the temporal lobes. MATERIALS AND METHODS: In this study, we examined whether tDCS over the left IFG in a group of patients with primary progressive aphasia (PPA), paired with a lexical/semantic retrieval intervention (oral and written naming), may specifically improve semantic fluency, a nontrained near-transfer task that relies on selective semantic retrieval, in patients with PPA. RESULTS: Semantic fluency improved significantly more in the active tDCS than in the sham tDCS condition immediately after and two weeks after treatment. This improvement was marginally significant two months after treatment. We also found that the active tDCS effect was specific to tasks that require this IFG computation (selective semantic retrieval) but not to other tasks that may require different computations of the frontal lobes. CONCLUSIONS: We provided interventional evidence that the left IFG is critical for selective semantic retrieval, and tDCS over the left IFG may have a near-transfer effect on tasks that depend on the same computation, even if they are not specifically trained. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02606422.


Assuntos
Afasia Primária Progressiva , Estimulação Transcraniana por Corrente Contínua , Humanos , Córtex Pré-Frontal , Semântica , Lobo Temporal , Afasia Primária Progressiva/diagnóstico por imagem , Afasia Primária Progressiva/terapia
4.
J Vasc Interv Radiol ; 33(12): 1492-1499, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35995120

RESUMO

PURPOSE: To determine whether celiac ganglion block can serve as a diagnostic test for dysautonomia as the cause of gastrointestinal dysmotility-related symptoms. MATERIALS AND METHODS: This was an institutional review board-approved, prospective, single-arm, registered study, from January 2020 to May 2021, and included patients aged 14-85 years with gastrointestinal symptoms of food intolerance, abdominal pain, or angina. Patients with nonneurogenic causes (ie, chronic cholecystitis, peptic ulcer disease, gastroesophageal reflux, and malabsorption syndrome) were excluded. All 15 patients underwent computed tomography-guided celiac ganglion block with 100 mg of liposomal bupivacaine. Patients filled out the dysautonomia-validated questionnaire Composite Autonomic Symptom Score 31 (COMPASS-31) before and after intervention. Differences (before vs after) were compared with the exact permutation method. RESULTS: Fifteen women (median age, 17 years; range, 14-41 years) were included. Average COMPASS-31 score improved significantly, from baseline 11 (SD ± 2.8) to 4 (SD ± 1.9) (improvement, 7 points ± 2.8; P < .001). All patients reported significant reduction in abdominal angina. Fourteen of the 15 patients (93%) reported complete resolution, and 14 of 15 (93%) reported a significant reduction in non-postprandial abdominal pain (P < .01). Only 1 patient reported no improvement. Eight of those 14 patients (57%) reported complete resolution of abdominal pain. There was a significant improvement in functional scores (vomiting, P = .01; constipation frequency, P = .02; constipation severity, P < .01; and nausea, P < .01). The rate of minor and major adverse events was 13% and 0%, respectively, per the Society of Interventional Radiology adverse event classification. CONCLUSIONS: Celiac ganglion block is a safe diagnostic tool for confirming dysautonomia as the underlying condition in patients with gastrointestinal dysmotility-related symptoms. It could provide early diagnosis, lead to definitive treatment (ganglionectomy) earlier, or obviate unnecessary surgery.


Assuntos
Gânglios Simpáticos , Disautonomias Primárias , Humanos , Feminino , Adolescente , Estudos Prospectivos , Gânglios Simpáticos/diagnóstico por imagem , Dor Abdominal/etiologia , Dor Abdominal/terapia , Tomografia Computadorizada por Raios X/efeitos adversos , Constipação Intestinal/complicações , Disautonomias Primárias/complicações
5.
Int J Mol Sci ; 23(13)2022 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-35806394

RESUMO

White matter pathology is common across a wide spectrum of neurological diseases. Characterizing this pathology is important for both a mechanistic understanding of neurological diseases as well as for the development of neuroimaging biomarkers. Although axonal calibers can vary by orders of magnitude, they are tightly regulated and related to neuronal function, and changes in axon calibers have been reported in several diseases and their models. In this study, we utilize the impact acceleration model of traumatic brain injury (IA-TBI) to assess early and late changes in the axon diameter distribution (ADD) of the mouse corticospinal tract using Airyscan and electron microscopy. We find that axon calibers follow a lognormal distribution whose parameters significantly change after injury. While IA-TBI leads to 30% loss of corticospinal axons by day 7 with a bias for larger axons, at 21 days after injury we find a significant redistribution of axon frequencies that is driven by a reduction in large-caliber axons in the absence of detectable degeneration. We postulate that changes in ADD features may reflect a functional adaptation of injured neural systems. Moreover, we find that ADD features offer an accurate way to discriminate between injured and non-injured mice. Exploring injury-related ADD signatures by histology or new emerging neuroimaging modalities may offer a more nuanced and comprehensive way to characterize white matter pathology and may also have the potential to generate novel biomarkers of injury.


Assuntos
Lesões Encefálicas Traumáticas , Substância Branca , Animais , Axônios/patologia , Lesões Encefálicas Traumáticas/patologia , Camundongos , Camundongos Endogâmicos , Tratos Piramidais/patologia , Substância Branca/patologia
6.
J Vasc Interv Radiol ; 32(8): 1203-1208.e1, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34332718

RESUMO

To evaluate outcomes in patients with right atrial (RA) hepatocellular carcinoma extension treated with transarterial chemoembolization. Eight patients were retrospectively reviewed. Follow-up visits occurred at 4-6 weeks; transarterial chemoembolization was repeated if residual tumor persisted. After transarterial chemoembolization, RA tumor volume reduction was 86% ± 19; α-fetoprotein level showed a reduction of 95%. From RA tumor diagnosis, 3-, 6-, and 12-month overall survival was 100% ± 0, 100% ± 0, and 67% ± 29, respectively. In patients with hepatocellular carcinoma invading the right atrium, transarterial chemoembolization alone or in combination with systemic therapy yields an improved imaging response and may be associated with improved survival.


Assuntos
Carcinoma Hepatocelular , Quimioembolização Terapêutica , Neoplasias Hepáticas , Carcinoma Hepatocelular/diagnóstico por imagem , Carcinoma Hepatocelular/terapia , Átrios do Coração/diagnóstico por imagem , Humanos , Neoplasias Hepáticas/diagnóstico por imagem , Neoplasias Hepáticas/terapia , Estudos Retrospectivos , Resultado do Tratamento
7.
AIDS Behav ; 25(7): 2108-2119, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33392969

RESUMO

Brief interventions to reduce frequent alcohol use among persons with HIV (PWH) are evidence-based, but resource-constrained settings must contend with competition for health resources. We evaluated the cost-effectiveness of two intervention arms compared to the standard of care (SOC) in a three-arm randomized control trial targeting frequent alcohol use in PWH through increasing the percent days abstinent from alcohol and viral suppression. We estimated incremental cost per quality-adjusted life year (QALY) gained from a modified societal perspective and a 1-year time horizon using a Markov model of health outcomes. The two-session brief intervention (BI), relative to the six-session combined intervention (CoI), was more effective and less costly; the estimated incremental cost-effectiveness of the BI relative to the SOC, was $525 per QALY gained. The BI may be cost-effective for the HIV treatment setting; the health utility gained from viral suppression requires further exploration.


Assuntos
Intervenção em Crise , Infecções por HIV , Análise Custo-Benefício , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Vietnã/epidemiologia
8.
Radiology ; 296(2): 452-459, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32515677

RESUMO

Background Percutaneous cryoablation (PCA) is an increasingly utilized treatment for stage I renal cell carcinoma (RCC), albeit without supportive level I evidence. Purpose Primary objective was to determine the 10-year oncologic outcomes of PCA for stage I RCC in a prospective manner. Secondary objectives were to compare outcomes after partial nephrectomy (PN) and radical nephrectomy (RN) from the National Cancer Database (NCDB), to determine long-term renal function, and to determine the risk of metachronous disease. Materials and Methods In this institutional review board-approved prospective observational study (2006-2013), study participants with single, sporadic, biopsy-proven RCC were included to calculate the 10-year overall survival, recurrence-free survival, and disease-specific survival after PCA. Results were compared with matched PN and RN NCDB cohorts. Overall and recurrence-free survival probabilities were estimated by using nonparametric maximum likelihood estimator. Disease-specific survival was estimated by using the redistribution-to-right method. Age at diagnosis was stratified as a risk for survival. The effect on estimated glomerular filtration rate, serum creatinine level, and the risk for hemodialysis and metachronous disease were calculated. Results One hundred thirty-four patients (46% men) with single, sporadic, biopsy-proven RCC (median size ± standard deviation, 2.8 cm ± 1.4) were included. Overall survival was 86% (95% confidence interval [CI]: 80%, 93%) and 72% (95% CI: 62%, 83%), recurrence-free survival was 85% (95% CI: 79%, 91%) and 69% (95% CI: 59%, 79%) (improved over surgery), and disease-specific survival was 94% (95% CI: 90%, 98%) at both 5 years and 10 years (similar to surgery), respectively. The 10-year risk of hemodialysis was 2.3%. Risk of metachronous RCC was 6%. Charlson/Deyo Combined Comorbidity score analysis showed decreasing overall survival with increasing comorbidity index. The PCA cohort outperformed both RN- and PN-matched subgroups in all Charlson/Deyo Combined Comorbidity score categories. Conclusion Percutaneous cryoablation yielded a 10-year disease-specific survival of 94%, equivalent to that reported after radical or partial nephrectomy. Overall survival probability after percutaneous cryoablation at 5 years and 10 years was longer than for radical or partial nephrectomy, especially for patients at higher risk (Charlson/Deyo Combined Comorbidity score ≥2). © RSNA, 2020.


Assuntos
Carcinoma de Células Renais , Criocirurgia , Neoplasias Renais , Idoso , Carcinoma de Células Renais/epidemiologia , Carcinoma de Células Renais/mortalidade , Carcinoma de Células Renais/cirurgia , Criocirurgia/efeitos adversos , Criocirurgia/mortalidade , Feminino , Taxa de Filtração Glomerular , Humanos , Neoplasias Renais/epidemiologia , Neoplasias Renais/mortalidade , Neoplasias Renais/cirurgia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
9.
AIDS Behav ; 24(9): 2555-2571, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32078077

RESUMO

We examined the prevalence of intimate partner violence (IPV) perpetration and characteristics of HIV-infected male perpetrators. The cross-sectional study was conducted in Vietnam with male antiretroviral treatment clients (N = 1099; mean age = 40.2 years). Bivariable associations were tested between psychological or physical/sexual IPV perpetration in the last 12 months and sociodemographic, psychosocial, and sexual behavioral factors using prevalence ratios. Factors significant at p < 0.10 were entered in multivariable models for each IPV outcome using a modified Poisson approach. Results showed 15.6% (N = 171/1099) reported perpetrating psychological IPV and 7.6% (N = 84/1099) perpetrating physical/sexual IPV in the last 12 months. HIV risk behaviors, including hazardous drinking and multiple sexual partners, having witnessed interparental violence as a child, and depressive symptoms were associated with perpetrating IPV. HIV interventions targeting HIV-infected men in Vietnam should intervene on IPV perpetration by addressing the co-occurring factors of sexual risk, depression, alcohol use, and child maltreatment that are correlated with IPV.


Assuntos
Antirretrovirais/uso terapêutico , Infecções por HIV/tratamento farmacológico , Violência por Parceiro Íntimo/psicologia , Adulto , Consumo de Bebidas Alcoólicas/epidemiologia , Consumo de Bebidas Alcoólicas/psicologia , Estudos Transversais , Depressão/epidemiologia , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Comportamento Sexual/psicologia , Inquéritos e Questionários , Vietnã/epidemiologia
10.
AIDS Behav ; 23(3): 609-616, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30357641

RESUMO

People who inject drugs (PWID) with HIV experience an elevated risk of death. A potentially important determinant of survival is the high burden of depression. This study examined the relationship of depressive symptoms at HIV testing with 2-year all-cause mortality among newly diagnosed HIV-positive PWID in Vietnam. At HIV testing, 141 PWID (42%) experienced severe depressive symptoms, and over the 2 years following diagnosis, 82 PWID (24%) died. Controlling for potential confounders, the 2-year risk of death among those with depressive symptoms was 9.7% (95% CI - 1.2, 20.6%) higher than the risk among those without depressive symptoms. This increased risk of mortality for PWID with depressive symptoms was relatively consistent throughout the 2-year period: at 6, 12, and 18 months, the risk difference was 12.6% (5.5-19.7%), 13.9% (4.6-23.2%), and 11.0% (0.9-21.1%), respectively. HIV diagnosis may provide an important opportunity for depression screening and treatment, subsequently improving survival in this key population.Trial registry: ClinicalTrials.gov NCT01689545.


Assuntos
Depressão/epidemiologia , Infecções por HIV/complicações , Infecções por HIV/psicologia , Abuso de Substâncias por Via Intravenosa/mortalidade , Adulto , Depressão/complicações , Depressão/psicologia , HIV , Infecções por HIV/epidemiologia , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Prevalência , Abuso de Substâncias por Via Intravenosa/complicações , Abuso de Substâncias por Via Intravenosa/psicologia , Vietnã/epidemiologia
11.
Clin Gastroenterol Hepatol ; 15(5): 746-755.e4, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-27847278

RESUMO

BACKGROUND & AIMS: There is debate over the best way to stage hepatocellular carcinoma (HCC). We attempted to validate the prognostic and clinical utility of the recently developed Hong Kong Liver Cancer (HKLC) staging system, a hepatitis B-based model, and compared data with that from the Barcelona Clinic Liver Cancer (BCLC) staging system in a North American population that underwent intra-arterial therapy (IAT). METHODS: We performed a retrospective analysis of data from 1009 patients with HCC who underwent IAT from 2000 through 2014. Most patients had hepatitis C or unresectable tumors; all patients underwent IAT, with or without resection, transplantation, and/or systemic chemotherapy. We calculated HCC stage for each patient using 5-stage HKLC (HKLC-5) and 9-stage HKLC (HKLC-9) system classifications, and the BCLC system. Survival information was collected up until the end of 2014 at which point living or unconfirmed patients were censored. We compared performance of the BCLC, HKLC-5, and HKLC-9 systems in predicting patient outcomes using Kaplan-Meier estimates, calibration plots, C statistic, Akaike information criterion, and the likelihood ratio test. RESULTS: Median overall survival time, calculated from first IAT until date of death or censorship, for the entire cohort (all stages) was 9.8 months. The BCLC and HKLC staging systems predicted patient survival times with significance (P < .001). HKLC-5 and HKLC-9 each demonstrated good calibration. The HKLC-5 system outperformed the BCLC system in predicting patient survival times (HKLC C = 0.71, Akaike information criterion = 6242; BCLC C = 0.64, Akaike information criterion = 6320), reducing error in predicting survival time (HKLC reduced error by 14%, BCLC reduced error by 12%), and homogeneity (HKLC chi-square = 201, P < .001; BCLC chi-square = 119, P < .001) and monotonicity (HKLC linear trend chi-square = 193, P < .001; BCLC linear trend chi-square = 111, P < .001). Small proportions of patients with HCC of stages IV or V, according to the HKLC system, survived for 6 months and 4 months, respectively. CONCLUSIONS: In a retrospective analysis of patients who underwent IAT for unresectable HCC, we found the HKLC-5 staging system to have the best combination of performances in survival separation, calibration, and discrimination; it consistently outperformed the BCLC system in predicting survival times of patients. The HKLC system identified patients with HCC of stages IV and V who are unlikely to benefit from IAT.


Assuntos
Neoplasias Hepáticas/diagnóstico , Neoplasias Hepáticas/patologia , Índice de Gravidade de Doença , Idoso , Embolização Terapêutica , Feminino , Humanos , Neoplasias Hepáticas/terapia , Masculino , Pessoa de Meia-Idade , América do Norte , Prognóstico , Estudos Retrospectivos
12.
Radiology ; 278(1): 275-84, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26131913

RESUMO

PURPOSE: To compare currently available non-three-dimensional methods (Response Evaluation Criteria in Solid Tumors [RECIST], European Association for Study of the Liver [EASL], modified RECIST [mRECIST[) with three-dimensional (3D) quantitative methods of the index tumor as early response markers in predicting patient survival after initial transcatheter arterial chemoembolization (TACE). MATERIALS AND METHODS: This was a retrospective single-institution HIPAA-compliant and institutional review board-approved study. From November 2001 to November 2008, 491 consecutive patients underwent intraarterial therapy for liver cancer with either conventional TACE or TACE with drug-eluting beads. A diagnosis of hepatocellular carcinoma (HCC) was made in 290 of these patients. The response of the index tumor on pre- and post-TACE magnetic resonance images was assessed retrospectively in 78 treatment-naïve patients with HCC (63 male; mean age, 63 years ± 11 [standard deviation]). Each response assessment method (RECIST, mRECIST, EASL, and 3D methods of volumetric RECIST [vRECIST] and quantitative EASL [qEASL]) was used to classify patients as responders or nonresponders by following standard guidelines for the uni- and bidimensional measurements and by using the formula for a sphere for the 3D measurements. The Kaplan-Meier method with the log-rank test was performed for each method to evaluate its ability to help predict survival of responders and nonresponders. Uni- and multivariate Cox proportional hazard ratio models were used to identify covariates that had significant association with survival. RESULTS: The uni- and bidimensional measurements of RECIST (hazard ratio, 0.6; 95% confidence interval [CI]: 0.3, 1.0; P = .09), mRECIST (hazard ratio, 0.6; 95% CI: 0.6, 1.0; P = .05), and EASL (hazard ratio, 1.1; 95% CI: 0.6, 2.2; P = .75) did not show a significant difference in survival between responders and nonresponders, whereas vRECIST (hazard ratio, 0.6; 95% CI: 0.3, 1.0; P = .04), qEASL (Vol) (hazard ratio, 0.5; 95% CI: 0.3, 0.9; P = .02), and qEASL (%) (hazard ratio, 0.3; 95% CI: 0.15, 0.60; P < .001) did show a significant difference between these groups. CONCLUSION: The 3D-based imaging biomarkers qEASL and vRECIST were tumor response criteria that could be used to predict patient survival early after initial TACE and enabled clear identification of nonresponders.


Assuntos
Carcinoma Hepatocelular/terapia , Quimioembolização Terapêutica/métodos , Diagnóstico por Imagem , Neoplasias Hepáticas/terapia , Idoso , Carcinoma Hepatocelular/patologia , Meios de Contraste/administração & dosagem , Doxorrubicina/administração & dosagem , Feminino , Gadolínio DTPA/administração & dosagem , Humanos , Neoplasias Hepáticas/patologia , Masculino , Microesferas , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
13.
AIDS Behav ; 20(1): 155-64, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25972071

RESUMO

Stigma and perceived social support can influence the decision to disclose HIV positive status, especially for people who inject drugs (PWID). In this analysis, the association between social support and HIV disclosure among 336 newly diagnosed HIV-infected PWID in Northern Vietnam was assessed. One month after diagnosis, 34.8 % of participants had not disclosed to anyone. Disclosure to anyone and to a family member specifically, was associated with baseline social support in the form of positive interactions and a history of incarceration. Disclosing to a family member was less likely among those who had unprotected sex in the previous 3 months. Disclosure to an injecting partner was more likely among those with a history of being in a drug treatment program, knowing someone on ART and believing that ART is safe. These data suggest that social support may facilitate disclosure among family members, including spouses, while disclosure to injecting partners is greater when PWID know that ART is a safe and viable option.


Assuntos
Infecções por HIV/psicologia , Autorrevelação , Estigma Social , Apoio Social , Abuso de Substâncias por Via Intravenosa/psicologia , Revelação da Verdade , Adolescente , Adulto , Discriminação Psicológica , Feminino , Infecções por HIV/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Parceiros Sexuais , Meio Social , Fatores Socioeconômicos , Abuso de Substâncias por Via Intravenosa/complicações , Vietnã , Adulto Jovem
14.
Biometrics ; 71(4): 867-74, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26237182

RESUMO

Researchers often seek robust inference for a parameter through semiparametric estimation. Efficient semiparametric estimation currently requires theoretical derivation of the efficient influence function (EIF), which can be a challenging and time-consuming task. If this task can be computerized, it can save dramatic human effort, which can be transferred, for example, to the design of new studies. Although the EIF is, in principle, a derivative, simple numerical differentiation to calculate the EIF by a computer masks the EIF's functional dependence on the parameter of interest. For this reason, the standard approach to obtaining the EIF relies on the theoretical construction of the space of scores under all possible parametric submodels. This process currently depends on the correctness of conjectures about these spaces, and the correct verification of such conjectures. The correct guessing of such conjectures, though successful in some problems, is a nondeductive process, i.e., is not guaranteed to succeed (e.g., is not computerizable), and the verification of conjectures is generally susceptible to mistakes. We propose a method that can deductively produce semiparametric locally efficient estimators. The proposed method is computerizable, meaning that it does not need either conjecturing, or otherwise theoretically deriving the functional form of the EIF, and is guaranteed to produce the desired estimates even for complex parameters. The method is demonstrated through an example.


Assuntos
Biometria/métodos , Modelos Estatísticos , Estudos de Viabilidade , Humanos
15.
Am J Geriatr Psychiatry ; 23(11): 1127-33, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26238225

RESUMO

OBJECTIVE: Agitation is a common and significant problem in Alzheimer disease (AD). In the recent Citalopram for Agitation in Alzheimer's Disease (CitAD) study, citalopram was efficacious for the treatment of AD agitation. Here we examined the time course and predictors of response to treatment. METHODS: Response in CitAD was defined as a modified Alzheimer Disease Cooperative Study Clinical Global Impression of Change (CGIC) score of 1 or 2 or a Neurobehavioral Rating Scale agitation subscale (NBRS-A) score reduction ≥ 50% from baseline. "Stable early response" was defined as meeting the aforementioned criteria at both weeks 3 and 9, "late response" was response at week 9 but not at week 3, and "unstable response" was response at week 3 but not at week 9. RESULTS: In the primary analyses, citalopram was superior to placebo on both the CGIC and the NBRS-A response measures. Little between-group differences were found in response rates in the first 3 weeks of the study (21% versus 19% on the CGIC). Citalopram patients were more likely than placebo patients to be a late responder (18% versus 8% on CGIC, Fisher's exact p = 0.09; 31% versus 15% on NBRS-A, Fisher's exact p = 0.02). Approximately half of citalopram responders (45%-56%) at end of study achieved response later in the study compared with 30%-44% of placebo responders. CONCLUSION: Treatment with citalopram for agitation in AD needs to be at least 9 weeks in duration to allow sufficient time for full response. Study duration is an important factor to consider in the design of clinical trials for agitation in AD.


Assuntos
Doença de Alzheimer/psicologia , Citalopram/uso terapêutico , Agitação Psicomotora/tratamento farmacológico , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Doença de Alzheimer/tratamento farmacológico , Método Duplo-Cego , Feminino , Humanos , Masculino , Escalas de Graduação Psiquiátrica , Fatores de Tempo , Resultado do Tratamento
16.
Int Psychogeriatr ; 27(12): 2059-67, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26305876

RESUMO

BACKGROUND: Placebo responses raise significant challenges for the design of clinical trials. We report changes in agitation outcomes in the placebo arm of a recent trial of citalopram for agitation in Alzheimer's disease (CitAD). METHODS: In the CitAD study, all participants and caregivers received a psychosocial intervention and 92 were assigned to placebo for nine weeks. Outcomes included Neurobehavioral Rating Scale agitation subscale (NBRS-A), modified AD Cooperative Study-Clinical Global Impression of Change (CGIC), Cohen-Mansfield Agitation Inventory (CMAI), the Neuropsychiatric Inventory (NPI) Agitation/Aggression domain (NPI A/A) and Total (NPI-Total) and ADLs. Continuous outcomes were analyzed with mixed-effects modeling and dichotomous outcomes with logistic regression. RESULTS: Agitation outcomes improved over nine weeks: NBRS-A mean (SD) decreased from 7.8 (3.0) at baseline to 5.4 (3.2), CMAI from 28.7 (6.7) to 26.7 (7.4), NPI A/A from 8.0 (2.4) to 4.9 (3.8), and NPI-Total from 37.3 (17.7) to 28.4 (22.1). The proportion of CGI-C agitation responders ranged from 21 to 29% and was significantly different from zero. MMSE improved from 14.4 (6.9) to 15.7 (7.2) and ADLs similarly improved. Most of the improvement was observed by three weeks and was sustained through nine weeks. The major predictor of improvement in each agitation measure was a higher baseline score in that measure. CONCLUSIONS: We observed significant placebo response which may be due to regression to the mean, response to a psychosocial intervention, natural course of symptoms, or nonspecific benefits of participation in a trial.


Assuntos
Agressão/efeitos dos fármacos , Doença de Alzheimer/psicologia , Antidepressivos de Segunda Geração/uso terapêutico , Citalopram/uso terapêutico , Efeito Placebo , Agitação Psicomotora/tratamento farmacológico , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Cuidadores/psicologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Escalas de Graduação Psiquiátrica , Índice de Gravidade de Doença , Resultado do Tratamento
17.
Biometrics ; 70(4): 1014-22, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25163648

RESUMO

We address estimation of intervention effects in experimental designs in which (a) interventions are assigned at the cluster level; (b) clusters are selected to form pairs, matched on observed characteristics; and (c) intervention is assigned to one cluster at random within each pair. One goal of policy interest is to estimate the average outcome if all clusters in all pairs are assigned control versus if all clusters in all pairs are assigned to intervention. In such designs, inference that ignores individual level covariates can be imprecise because cluster-level assignment can leave substantial imbalance in the covariate distribution between experimental arms within each pair. However, most existing methods that adjust for covariates have estimands that are not of policy interest. We propose a methodology that explicitly balances the observed covariates among clusters in a pair, and retains the original estimand of interest. We demonstrate our approach through the evaluation of the Guided Care program.


Assuntos
Algoritmos , Análise por Conglomerados , Modelos Estatísticos , Avaliação de Resultados em Cuidados de Saúde/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa , Calibragem , Simulação por Computador , Interpretação Estatística de Dados , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos
18.
Am J Geriatr Psychiatry ; 22(1): 14-24, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24314887

RESUMO

OBJECTIVE: We wanted to assess if sertraline treatment (versus placebo) or remission of depression at 12 weeks (versus nonremission) in Alzheimer patients is associated with improved caregiver well being. METHODS: We conducted a randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of sertraline for the treatment of depression in individuals with Alzheimer disease in five clinical research sites across the United States. Participants were caregivers of patients enrolled in the Depression in Alzheimer's Disease Study 2 (N = 131). All caregivers received standardized psychosocial support throughout the study. Caregiver outcome measures included depression (Beck Depression Inventory), distress (Neuropsychiatric Inventory), burden (Zarit Burden Interview), and quality of life (Medical Outcomes Study Short Form Health Survey). RESULTS: Fifty-nine percent of caregivers were spouses, 63.4% were women, and 64.1% were white. Caregivers of patients in both treatment groups had significant reductions in distress scores over the 24-week study period, but there was not a greater benefit for caregivers of patients taking sertraline. However, caregivers of patients whose depression was in remission at week 12 had greater declines in distress scores over the 24 weeks than caregivers of patients whose depression did not remit by week 12. CONCLUSION: Patient treatment with sertraline was not associated with significantly greater reductions in caregiver distress than placebo treatment. Distress but not level of depression or burden lessened for all caregivers regardless of remission status and even more so for those who cared for patients whose depression remitted. Results imply an interrelationship between caregiver distress and patient psychiatric outcomes.


Assuntos
Doença de Alzheimer/enfermagem , Doença de Alzheimer/psicologia , Cuidadores/psicologia , Depressão/tratamento farmacológico , Qualidade de Vida/psicologia , Sertralina/uso terapêutico , Estresse Psicológico , Idoso , Doença de Alzheimer/complicações , Efeitos Psicossociais da Doença , Depressão/complicações , Depressão/enfermagem , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Escalas de Graduação Psiquiátrica , Remissão Espontânea , Sertralina/efeitos adversos
19.
Stat Med ; 33(12): 2017-29, 2014 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-24408038

RESUMO

Most studies that follow subjects over time are challenged by having some subjects who dropout. Double sampling is a design that selects and devotes resources to intensively pursue and find a subset of these dropouts, then uses data obtained from these to adjust naïve estimates, which are potentially biased by the dropout. Existing methods to estimate survival from double sampling assume a random sample. In limited-resource settings, however, generating accurate estimates using a minimum of resources is important. We propose using double-sampling designs that oversample certain profiles of dropouts as more efficient alternatives to random designs. First, we develop a framework to estimate the survival function under these profile double-sampling designs. We then derive the precision of these designs as a function of the rule for selecting different profiles, in order to identify more efficient designs. We illustrate using data from the United States President's Emergency Plan for AIDS Relief-funded HIV care and treatment program in western Kenya. Our results show why and how more efficient designs should oversample patients with shorter dropout times. Further, our work suggests generalizable practice for more efficient double-sampling designs, which can help maximize efficiency in resource-limited settings.


Assuntos
Síndrome da Imunodeficiência Adquirida/mortalidade , Cooperação Internacional , Projetos de Pesquisa , Estudos de Amostragem , Análise de Sobrevida , Algoritmos , Humanos , Quênia/epidemiologia , Estados Unidos
20.
JAMA ; 311(7): 682-91, 2014 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-24549548

RESUMO

IMPORTANCE: Agitation is common, persistent, and associated with adverse consequences for patients with Alzheimer disease. Pharmacological treatment options, including antipsychotics are not satisfactory. OBJECTIVE: The primary objective was to evaluate the efficacy of citalopram for agitation in patients with Alzheimer disease. Key secondary objectives examined effects of citalopram on function, caregiver distress, safety, cognitive safety, and tolerability. DESIGN, SETTING, AND PARTICIPANTS: The Citalopram for Agitation in Alzheimer Disease Study (CitAD) was a randomized, placebo-controlled, double-blind, parallel group trial that enrolled 186 patients with probable Alzheimer disease and clinically significant agitation from 8 academic centers in the United States and Canada from August 2009 to January 2013. INTERVENTIONS: Participants (n = 186) were randomized to receive a psychosocial intervention plus either citalopram (n = 94) or placebo (n = 92) for 9 weeks. Dosage began at 10 mg per day with planned titration to 30 mg per day over 3 weeks based on response and tolerability. MAIN OUTCOMES AND MEASURES: Primary outcome measures were based on scores from the 18-point Neurobehavioral Rating Scale agitation subscale (NBRS-A) and the modified Alzheimer Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC). Other outcomes were based on scores from the Cohen-Mansfield Agitation Inventory (CMAI) and the Neuropsychiatric Inventory (NPI), ability to complete activities of daily living (ADLs), caregiver distress, cognitive safety (based on scores from the 30-point Mini Mental State Examination [MMSE]), and adverse events. RESULTS: Participants who received citalopram showed significant improvement compared with those who received placebo on both primary outcome measures. The NBRS-A estimated treatment difference at week 9 (citalopram minus placebo) was -0.93 (95% CI, -1.80 to -0.06), P = .04. Results from the mADCS-CGIC showed 40% of citalopram participants having moderate or marked improvement from baseline compared with 26% of placebo recipients, with estimated treatment effect (odds ratio [OR] of being at or better than a given CGIC category) of 2.13 (95% CI, 1.23-3.69), P = .01. Participants who received citalopram showed significant improvement on the CMAI, total NPI, and caregiver distress scores but not on the NPI agitation subscale, ADLs, or in less use of rescue lorazepam. Worsening of cognition (-1.05 points; 95% CI, -1.97 to -0.13; P = .03) and QT interval prolongation (18.1 ms; 95% CI, 6.1-30.1; P = .01) were seen in the citalopram group. CONCLUSIONS AND RELEVANCE: Among patients with probable Alzheimer disease and agitation who were receiving psychosocial intervention, the addition of citalopram compared with placebo significantly reduced agitation and caregiver distress; however, cognitive and cardiac adverse effects of citalopram may limit its practical application at the dosage of 30 mg per day. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00898807.


Assuntos
Doença de Alzheimer/complicações , Citalopram/uso terapêutico , Agitação Psicomotora/tratamento farmacológico , Agitação Psicomotora/etiologia , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Doença de Alzheimer/enfermagem , Doença de Alzheimer/fisiopatologia , Arritmias Cardíacas/induzido quimicamente , Cuidadores/psicologia , Citalopram/efeitos adversos , Cognição/efeitos dos fármacos , Método Duplo-Cego , Feminino , Humanos , Masculino , Inibidores Seletivos de Recaptação de Serotonina/efeitos adversos , Índice de Gravidade de Doença , Estresse Psicológico , Resultado do Tratamento
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