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1.
Clin Trials ; 20(6): 714-717, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37269077

RESUMO

INTRODUCTION: Failure to provide effortful performance on cognitive testing is not uncommon for participants in clinical trials and can significantly impact sensitivity to treatment effect. Whether poor effort on cognitive testing might relate to other behaviors of interest is unknown. In the current investigation, we examined whether effort on baseline cognitive testing in a randomized controlled trial to enhance resiliency in US Army Officers predicted subsequent success in Ranger school. METHODS: Baseline data on six cognitive tests were obtained from 237 US Army Officers entering a military training program prior to attempting Ranger School. Participation was voluntary and the Army was not informed of test scores. "Poor effort" was defined by chance-level accuracy or extreme outlier scores. Logistic regression examined likelihood of Ranger success according to the number of tests with poor effort. RESULTS: Overall, 170 (72%) participants provided good effort on all tests. For these participants, 47% were successful in Ranger, versus 32% with poor effort on one test and 14% with poor effort on two tests. Logistic regression analysis found poor effort on baseline testing predicted reduced likelihood of Ranger success, ß =-.486, p = .005. DISCUSSION: A substantial number of participants exhibited poor effort on testing, and poor effort was predictive of failure in Ranger school. Findings highlight the importance of assessing effort in clinical trials involving cognitive outcomes and suggest application of cognitive effort testing in trials where other motivated behavior is targeted. REGISTRATION: Clinical Trials.gov NCT02908932.


Assuntos
Militares , Humanos , Militares/psicologia , Ensaios Clínicos como Assunto , Testes Neuropsicológicos , Instituições Acadêmicas
2.
Am J Perinatol ; 39(11): 1159-1165, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35235958

RESUMO

OBJECTIVE: While antenatal corticosteroids (ACS) administered in the late preterm period have been shown to reduce respiratory morbidity, this finding was demonstrated in a well-designed randomized controlled trial (the Antenatal Betamethasone for Women at Risk for Late Preterm Delivery [ALPS]) with strict inclusion/exclusion criteria that may differ from clinical practice. The aim of this study was to investigate whether there has been indication creep since use of late preterm ACS became standard of care. STUDY DESIGN: Retrospective cohort study of pregnant women who received late preterm ACS between 2016 and 2019 were identified and separated into epochs of 2016 to 2017 and 2018 to 2019 based on year of exposure. The primary outcome was rate of inappropriate ACS exposure, defined as nonadherence to the inclusion/exclusion criteria of the ALPS trial. Secondary outcomes were rates of nonoptimal ACS exposure (delivery >7 days from ACS or term delivery). Logistic regression was used to generate adjusted odds ratios (aORs) between epochs for the primary outcome adjusting for confounders. RESULTS: There were 660 women who received late preterm ACS during the study period with 229 (34.6 %) deemed inappropriate exposures. The most common reason for inappropriate treatment was preterm premature rupture of membrane (PPROM; 29.0%) with exclusionary cervical examination or contraction frequency. No difference was observed in inappropriate ACS exposure between epochs (aOR = 0.83, 95% confidence interval [CI]: 0.59-1.2). However, there was a reduction in nonoptimal exposure over time (aOR = 0.67, 95% CI: 0.47-0.97) . Women receiving inappropriate ACS were more likely to deliver at term if indicated for maternal/fetal status (50.0 vs. 19.5%, p < 0.001) and preterm labor (66.0 vs. 41.9%; p = 0.015). Further, inappropriate exposure in preterm labor had higher rates of exposure latency >7 days (62.3 vs. 39.1%, p = 0.006) with a longer latency to delivery (3 vs. 16 days; p < 0.001). CONCLUSION: Over one-third of women received late preterm ACS for an indication that could be classified as indication creep. Depending on indication, inappropriate administration is associated with higher rates of nonoptimal exposure. KEY POINTS: · There is potential for indication creep of ACS administration.. · One third of late preterm ACS exposures in our study were inappropriate.. · Utilizing clinical criteria can aid in identifying patients who best benefit from late preterm ACS..


Assuntos
Trabalho de Parto Prematuro , Nascimento Prematuro , Síndrome do Desconforto Respiratório do Recém-Nascido , Corticosteroides , Betametasona , Feminino , Humanos , Recém-Nascido , Gravidez , Estudos Retrospectivos
3.
J Stroke Cerebrovasc Dis ; 30(8): 105815, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34052785

RESUMO

BACKGROUND: Geographical and racial disparities in stroke outcomes are especially prominent in the Southeastern United States, which represents a region more heavily burdened with stroke compared to the rest of the country. While stroke is eminently preventable, particularly via blood pressure control, fewer than one third of patients with a stroke have their blood pressure controlled ≥ 75% of the time, and low consistency of blood pressure control is linked to higher stroke risk. OBJECTIVE: To demonstrate that a mHealth technology-centered, integrated approach can effectively improve sustained blood pressure control among stroke patients (half of whom will be Black). DESIGN: The Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor is a prospective randomized controlled trial, which will include a cohort of 200 patients with a stroke, encountered at two major safety net health care systems in South Carolina. The intervention comprises utilization of a Vaica electronic pill tray & blue-toothed UA-767Plus BT blood pressure device and a dedicated app installed on patients' smart phones for automatic relay of data to a central server. Providers will follow care protocols based on expert consensus practice guidelines to address optimal blood pressure management. STUDY OUTCOMES: Primary outcome is systolic blood pressure at 12-months, which is the major modifiable step to stroke event rate reduction. Secondary endpoints include control of other stroke risk factors, medication adherence, functional status, and quality of life. DISCUSSION: We anticipate that a successful intervention will serve as a scalable model of effective chronic blood pressure management after stroke, to bridge racial and geographic disparities in stroke outcomes in the United States. TRIAL REGISTRATION: ClinicalTrials.gov - NCT03401489.


Assuntos
Pressão Sanguínea/efeitos dos fármacos , Hipertensão/tratamento farmacológico , Provedores de Redes de Segurança , Prevenção Secundária , Autocuidado , Acidente Vascular Cerebral/prevenção & controle , Telemedicina , Adolescente , Adulto , Negro ou Afro-Americano , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Hipertensão/diagnóstico , Hipertensão/etnologia , Hipertensão/fisiopatologia , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Aplicativos Móveis , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores de Risco , Smartphone , South Carolina , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etnologia , Fatores de Tempo , Resultado do Tratamento , População Branca , Adulto Jovem
4.
N Engl J Med ; 377(8): 733-744, 2017 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-28834483

RESUMO

BACKGROUND: The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here. METHODS: We randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment group among all participants and among participants stratified according to physical and cognitive function. RESULTS: Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood-pressure care was high in both treatment groups, and we found no significant difference in adherence to blood-pressure medications. CONCLUSIONS: Patient-reported outcomes among participants who received intensive treatment, which targeted a systolic blood pressure of less than 120 mm Hg, were similar to those among participants who received standard treatment, including among participants with decreased physical or cognitive function. (Funded by the National Institutes of Health; SPRINT ClinicalTrials.gov number, NCT01206062 .).


Assuntos
Anti-Hipertensivos/administração & dosagem , Doenças Cardiovasculares/prevenção & controle , Hipertensão/tratamento farmacológico , Medidas de Resultados Relatados pelo Paciente , Idoso , Anti-Hipertensivos/efeitos adversos , Pressão Sanguínea/efeitos dos fármacos , Quimioterapia Combinada , Feminino , Nível de Saúde , Humanos , Hipertensão/complicações , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Avaliação de Resultados da Assistência ao Paciente , Satisfação do Paciente
5.
J Sex Med ; 17(2): 238-248, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31862174

RESUMO

INTRODUCTION: The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown. AIM: To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension. METHODS: We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg). MAIN OUTCOME MEASURE: The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years. RESULTS: At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = -1.17; 95% CI = -1.92, -0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity. CLINICAL IMPLICATIONS: The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude. STRENGTH & LIMITATIONS: Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed. CONCLUSION: In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238-248.


Assuntos
Pressão Sanguínea/efeitos dos fármacos , Disfunção Erétil/fisiopatologia , Hipertensão/tratamento farmacológico , Ereção Peniana/fisiologia , Idoso , Etnicidade , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Autorrelato , Sístole
6.
J Nutr ; 149(8): 1404-1412, 2019 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-31132112

RESUMO

BACKGROUND: Nutrients are added to the diet through fortification/enrichment and dietary supplements (DSs). Meeting the US Dietary Reference Intakes (DRIs) varies by nutrient and population subsegments. OBJECTIVE: The aim of this study was to assess the relative role of naturally occurring, enriched/fortified, and DS sources of 15 micronutrients with reference to the DRIs. METHODS: We used the NHANES 2009-2012 (≥2 y old, n = 16,975) data, the ILSI North America Fortification database, and the National Cancer Institute usual intake method. RESULTS: Prevalence of nutrient intake from naturally occurring sources below the Estimated Average Requirement (EAR) varied from 5% for vitamin B-12 to 100% for vitamin D, with ≥40% of the population below the EAR for 8 of the 14 nutrients (ages ≥2 y). With enrichment/fortification, the percentage below the EAR decreased to the following for vitamins A (35%), C (34%), and B-6 (7%), folate (8%), thiamin (5%), riboflavin (3%), niacin (1%), and iron (2%). Nutrients from DSs further improved intakes related to the EAR for 12 nutrients (ages ≥2 y). For 9-18-y-olds, the percentages of nutrient intakes below the EAR were 14-50% higher than for 2-8-y-olds. The Tolerable Upper Intake Level (UL) was exceeded among children aged 2-8 y for folate (41.7%), niacin (10.1%), and zinc (39.9%), whereas among ages ≥2 y and 9-18 y no prevalence of intakes over the UL exceeded 10%. CONCLUSIONS: Fortification/enrichment constitutes a meaningful contribution to reducing the percentage of individuals with less than the EAR for their demographic. These data underscore the need to encourage better dietary patterns to improve the intake of nutrients at risk of low intake.


Assuntos
Bebidas , Dieta , Suplementos Nutricionais , Alimentos Fortificados , Inquéritos Nutricionais , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Estados Unidos
7.
J Sex Med ; 16(2): 235-247, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30655182

RESUMO

INTRODUCTION: Erectile function, an important aspect of quality of life, is gaining increased research and clinical attention in older men with hypertension. AIM: To assess the cross-sectional association between blood pressure measures (systolic blood pressure [SBP]; diastolic blood pressure [DBP]; and pulse pressure [PP]) and (i) sexual activity and (ii) erectile function in hypertensive men. METHODS: We performed analyses of 1,255 male participants in a larger randomized clinical trial of 9,361 men and women with hypertension aged ≥50 years. MAIN OUTCOME MEASURES: The main outcome measures were self-reported sexual activity (yes/no) and erectile function using the 5-item International Index of Erectile Function (IIEF-5). RESULTS: 857 participants (68.3%) reported being sexually active during the previous 4 weeks. The mean (SD) IIEF-5 score for sexually active participants was 18.0 (5.8), and 59.9% of the sample reported an IIEF-5 score <21, suggesting erectile dysfunction (ED). In adjusted logistic regression models, neither SBP (adjusted odds ratio = 0.998; P = .707) nor DBP (adjusted odds ratio = 1.001; P = .929) was significantly associated with sexual activity. In multivariable linear regression analyses in sexually active participants, lower SBP (ß = -0.04; P = .025) and higher DBP (ß = 0.05; P = .029) were associated with better erectile function. In additional multivariable analyses, lower PP pressure was associated with better erectile function (ß = -0.04; P = .02). CLINICAL IMPLICATIONS: Blood pressure is an important consideration in the assessment of erectile function in men with hypertension. STRENGTHS & LIMITATIONS: Assessments of blood pressure and clinical and psychosocial variables were performed using rigorous methods in this multi-ethnic and geographically diverse sample. However, these cross-sectional analyses did not include assessment of androgen or testosterone levels. CONCLUSIONS: Erectile dysfunction was highly prevalent in this sample of men with hypertension, and SBP, DBP, and PP were associated with erectile function in this sample. Foy CG, Newman JC, Berlowitz DR, et al. Blood Pressure, Sexual Activity, and Erectile Function in Hypertensive Men: Baseline Findings from the Systolic Blood Pressure Intervention Trial (SPRINT). J Sex Med 2019;16:235-247.


Assuntos
Disfunção Erétil/epidemiologia , Hipertensão , Idoso , Pressão Sanguínea , Estudos Transversais , Disfunção Erétil/fisiopatologia , Disfunção Erétil/psicologia , Humanos , Masculino , Saúde do Homem , Pessoa de Meia-Idade , Razão de Chances , Ereção Peniana , Comportamento Sexual , Estados Unidos/epidemiologia
8.
Paediatr Child Health ; 23(8): e163-e169, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30842698

RESUMO

OBJECTIVE: To evaluate predictive validity and establish cut-off scores on the Bayley-III at age 21 months that best predict Intelligence Quotient (IQ) scores <70 or <80) at 3 years in a high-risk preterm cohort. METHOD: Bayley-III evaluations at 21 months corrected age and intellectual assessments, primarily with the WPPSI-III, at 3 years corrected age were conducted with 520 infants born less than 29 weeks gestational age or less than 1250 g birth weight. Receiver Operator Characteristic (ROC) curves were used to establish Bayley-III Cognitive Composite cut-off scores that maximized Sensitivity and Specificity in predicting low IQ. Similar analyses were performed using the Language Composite, and a research derived mean Cognitive-Language Composite. RESULTS: A regression model for the association between 21-month Bayley-III Cognitive Composite and 3-year IQ scores was significant (P<0.0001, Adjusted R2=0.36). The ROC area under the Curve was 0.90 for the Cognitive Composite predicting IQ<70. The cut-off score that maximized Sensitivity and Specificity for predicting 3-year IQ<70 was a Cognitive Composite of <80. The ROC Area under the Curve was 0.80 for Cognitive Composites predicting IQ<80 and a Cognitive Composite cut-off score of <90 maximized Sensitivity and Specificity. CONCLUSION: In this high-risk preterm cohort, there was a strong association between the Bayley-III Cognitive Composite at 21 months and IQ at 3 years. A Cognitive Composite cut-off score of <80 optimized classification of IQ<70 at 3 years, and a Cognitive Composite cut-off score of <90 optimized classification of IQ<80.

9.
Muscle Nerve ; 54(1): 31-5, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-26579702

RESUMO

INTRODUCTION: The association between musculoskeletal injuries and carpal tunnel syndrome (CTS) has not been investigated in a large, population-based study. METHODS: Latino manual laborers were recruited as part of a study of work-related health conditions. Each had a clinical examination, completed a hand diagram, and had nerve conduction studies. RESULTS: A total of 512 individuals completed all testing. An association was found between rotator cuff syndrome and CTS, with an adjusted odds ratio of 2.25 (P = 0.01) for the right arm, 2.08 (P = 0.03) for the left arm, and 1.84 (P = 0.03) for all individuals. Associations between epicondylitis and CTS did not reach statistical significance. CONCLUSIONS: Individuals with rotator cuff syndrome have a higher prevalence of CTS. Further investigations will be needed to examine for causation and to determine if 1 condition typically occurs first and leads to the other. Muscle Nerve 54: 31-35, 2016.


Assuntos
Síndrome do Túnel Carpal/diagnóstico , Síndrome do Túnel Carpal/epidemiologia , Doenças Musculoesqueléticas/diagnóstico , Doenças Musculoesqueléticas/epidemiologia , Doenças Profissionais/diagnóstico , Doenças Profissionais/epidemiologia , Adulto , Índice de Massa Corporal , Planejamento em Saúde Comunitária , Feminino , Hispânico ou Latino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Autorrelato
10.
J Sex Med ; 13(9): 1333-1346, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27555505

RESUMO

INTRODUCTION: Sexual function, an important component of quality of life, is gaining increased research and clinical attention in older women with hypertension. AIM: To assess the association between systolic blood pressure (SBP) and other variables, and sexual activity and sexual dysfunction in hypertensive women. METHODS: Baseline analysis of 635 women participants of a larger randomized clinical trial of 9361 men and women. MAIN OUTCOME MEASURES: Self-reported sexual activity (yes/no), and sexual function using the Female Sexual Function Inventory (FSFI). RESULTS: 452 participants (71.2%) reported having no sexual activity during the previous 4 weeks. The mean (SD) FSFI score for sexually active participants was 25.3 (6.0), and 52.6% of the sample reported a FSFI score ≤26.55 designating sexual dysfunction. In logistic regression models, SBP was not significantly associated with sexual activity (AOR = 1.002; P > .05). Older age (AOR = 0.95, P < .05), and lower education (AOR for < high school vs college degree = 0.29, P < .05) were associated with lower odds of being sexually active, as was living alone versus living with others (AOR = 0.56, P < .05). Higher weekly alcohol consumption was associated with increased odds of being sexually active (AOR = 1.39; P < .05). In logistic regression models among sexually active participants, SBP was not associated with sexual dysfunction (AOR = 1.01; P > .05). Higher depressive symptoms from the Patient Health Questionnaire-9 (PHQ-9) was associated with higher odds of sexual dysfunction (AOR = 1.24, P < .05), as was increased number of physical comorbidities (AOR = 1.25, P < .05). Diuretic use was associated with lower odds of being sexually active in participants with chronic kidney disease (AOR = 0.33, P < .05). CONCLUSION: Younger age, higher education, living with others, and higher weekly alcohol consumption were significantly associated with higher odds of being sexually active in a sample of middle-aged and older women with hypertension. Increased depressive symptoms and increased physical comorbidities were significantly associated with increased odds of sexual dysfunction. SBP was not significantly associated with sexual activity or sexual dysfunction.


Assuntos
Hipertensão/complicações , Qualidade de Vida , Disfunções Sexuais Fisiológicas/etiologia , Disfunções Sexuais Psicogênicas/etiologia , Adulto , Idoso , Pressão Sanguínea , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Comportamento Sexual , Disfunções Sexuais Fisiológicas/diagnóstico , Disfunções Sexuais Psicogênicas/diagnóstico
11.
Clin Trials ; 12(3): 189-98, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25733676

RESUMO

BACKGROUND/AIMS: Suicide is a major public health concern, yet there are very few randomized clinical trials that have been conducted to reduce suicidal ideation in patients at risk of suicide. We describe the rationale and refinements of such a trial that is designed to assess the effect of a hypnotic medication on suicidal ideation in adult outpatients currently experiencing suicidal ideation. METHODS: "Reducing Suicidal Ideation Through Insomnia Treatment" is a multi-site randomized clinical trial that includes three recruiting sites and one data management site. This 4-year study is in its second year of recruitment. The purpose of the study is to compare hypnotic medication versus placebo as an add-on treatment to a selective serotonin reuptake inhibitor as a means of reducing suicidal ideation in depressed adult outpatients with insomnia and suicidal ideation. The safety features of the study follow the 2001 National Institutes of Health guidelines for studies that include patients at risk of suicide. RESULTS: In total, 584 potential participants have undergone telephone screening; 67% of these failed the phone screen, most often due to an absence of expressed suicidal ideation (26% of the telephone screen fails). A total of 115 people appeared for a face-to-face baseline assessment, and 40 of these had completed a taper off of their ineffective psychotropic medications before the baseline assessments. In all, 64% of those who completed baseline assessments failed to proceed to randomization, most commonly because of no clinically significant suicidal ideation (51% of those excluded at baseline). One participant was offered and accepted voluntary psychiatric hospitalization in lieu of study participation. Thus far, 40 participants have been randomized into the study and 88.7% of scheduled visits have been attended, with 93.8% adherence to the selective serotonin reuptake inhibitor and 91.6% adherence to the randomized hypnotic versus placebo. None of the randomized participants have required hospitalization or had a suicide attempt. CONCLUSION: By carefully considering the inclusion and exclusion criteria and other safety features, the safe conduct of randomized clinical trials in suicidal adult patients is possible, including the inclusion of participants who have undergone a prescribed tapering off of psychotropic medications prior to baseline assessment.


Assuntos
Transtorno Depressivo Maior/complicações , Transtorno Depressivo Maior/tratamento farmacológico , Hipnóticos e Sedativos/uso terapêutico , Projetos de Pesquisa , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Ideação Suicida , Adulto , Quimioterapia Combinada , Feminino , Humanos , Hipnóticos e Sedativos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Seleção de Pacientes , Inibidores Seletivos de Recaptação de Serotonina/administração & dosagem , Fatores Socioeconômicos , Estados Unidos
12.
Muscle Nerve ; 50(4): 517-22, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24449488

RESUMO

INTRODUCTION: The aim of this study was to determine whether there is an association between flexor digitorum and lumbrical muscle intrusion into the carpal tunnel and carpal tunnel syndrome (CTS). METHODS: Five hundred thirteen manual laborers (1026 wrists) were evaluated with ultrasound to determine whether those with CTS had more muscle intrusion into the carpal tunnel than those without CTS. One hundred ninety of the participants without CTS at baseline (363 wrists) were followed over 1 year to determine whether muscle intrusion at baseline predicted the development of CTS. RESULTS: Participants with CTS had more muscle within the carpal tunnel with the wrist in the neutral (P=0.026) and flexed (P=0.018) positions than those without CTS. Baseline muscle intrusion did not predict development of CTS at 1 year. CONCLUSIONS: Muscle intrusion into the carpal tunnel is associated with CTS, but muscle intrusion alone does not predict the development of CTS over the course of a year.


Assuntos
Ossos do Carpo/patologia , Síndrome do Túnel Carpal/etiologia , Músculo Esquelético/patologia , Músculo Esquelético/fisiopatologia , Adulto , Ossos do Carpo/ultraestrutura , Síndrome do Túnel Carpal/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Peso Corporal Ideal , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Ultrassonografia , Punho/inervação , Adulto Jovem
13.
Am J Ind Med ; 57(5): 605-14, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24343776

RESUMO

BACKGROUND: Manual labor employment occurs in environments with exposures likely to impact skin-related quality of life (SRQOL). OBJECTIVES: The objectives of this paper are to (1) document the dimensions of SRQOL, (2) examine its association with skin symptoms, and (3) identify the predictors of SRQOL in Latino manual workers. METHODS: A population-based survey of 733 Latino manual workers obtained Dermatology Life Quality Index (DLQI) and skin symptoms in the prior year. RESULTS: Two-thirds of workers were employed in production. Skin symptoms in prior year were reported by 23%. Impaired SRQOL was reported by 23%. In multivariate analyses, reduced SRQOL was associated with age, occupation, childhood indigenous language use, and experience of skin symptoms in the prior year. CONCLUSIONS: Despite overall high SRQOL exposures in some immigrant occupational groups produce reduce SRQOL. This rural, immigrant population faces significant obstacles to obtaining dermatological care; efforts are needed to improve their SRQOL.


Assuntos
Doenças dos Trabalhadores Agrícolas/epidemiologia , Indústria da Construção , Dermatite Ocupacional/epidemiologia , Emigrantes e Imigrantes/estatística & dados numéricos , Indústria de Processamento de Alimentos , Hispânico ou Latino/estatística & dados numéricos , Qualidade de Vida , Adolescente , Adulto , Fatores Etários , Feminino , Humanos , Masculino , Fatores de Risco , Adulto Jovem
14.
Am J Ind Med ; 57(3): 362-9, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23996875

RESUMO

OBJECTIVE: To determine the incidence of carpal tunnel syndrome (CTS) over 1 year in Latino poultry processing workers. METHODS: Symptoms and nerve conduction studies were used to identify Latino poultry processing workers (106 wrists) and Latinos in other manual labor occupations (257 wrists) that did not have CTS at baseline, and these individuals were then evaluated in the same manner 1 year later. RESULTS: Based on wrists, the 1-year incidence of CTS was higher in poultry processing workers than non-poultry manual workers (19.8% vs. 11.7%, P = 0.022). Poultry workers had a higher odds (1.89; P = 0.089) of developing CTS over 1 year compared to non-poultry manual workers. DISCUSSION: Latino poultry processing workers have an incidence of CTS that is possibly higher than Latinos in other manual labor positions. Latino poultry workers' high absolute and relative risk of CTS likely results from the repetitive and strenuous nature of poultry processing work.


Assuntos
Síndrome do Túnel Carpal/epidemiologia , Hispânico ou Latino/estatística & dados numéricos , Doenças Profissionais/epidemiologia , Adulto , Estudos de Casos e Controles , Feminino , Indústria de Processamento de Alimentos/estatística & dados numéricos , Humanos , Incidência , Masculino , Condução Nervosa , North Carolina/epidemiologia , Adulto Jovem
15.
South Med J ; 107(6): 374-9, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24945173

RESUMO

OBJECTIVES: Latino immigrant workers experience elevated rates of skin disease that result from their working and living conditions. Working in manual occupations exposes workers to a variety of challenges, including occlusive shoes, vigorous physical activity, and wet conditions. These challenges predispose workers to fungal infection. The objectives of this article are to examine the comorbidity of tinea pedis and onychomycosis and to identify possible risk factors among Latino immigrant poultry and nonpoultry workers in western North Carolina. METHODS: Data were obtained from a cross-sectional study conducted between June 2009 and November 2010 in rural western North Carolina among 518 manual Latino immigrant workers to assess their occupational injuries. Participants completed a face-to-face interview and a dermatologic examination. RESULTS: Nearly one-third of the participants (32%) were diagnosed as having onychomycosis and more than one-third (37.8%) were diagnosed as having tinea pedis. There was a greater prevalence of tinea pedis in men than women (71.3% vs 28.7%, respectively). Of the 518 participants, 121 (23.5%) had both conditions. Participants who reported the use of occlusive shoes as "always" or "most of the time" had a higher prevalence of comorbid onychomycosis and tinea pedis than the rest of the group. CONCLUSIONS: Comorbidity of tinea pedis and onychomycosis is common among immigrant Latino men and women who perform manual labor. Further studies confirming the presence and type of dermatophyte should be conducted.


Assuntos
Emigrantes e Imigrantes/estatística & dados numéricos , Hispânico ou Latino/estatística & dados numéricos , Indústria de Embalagem de Carne/estatística & dados numéricos , Doenças Profissionais/epidemiologia , Onicomicose/epidemiologia , Tinha dos Pés/epidemiologia , Adolescente , Adulto , Animais , Comorbidade , Estudos Transversais , Feminino , Humanos , Masculino , North Carolina/epidemiologia , Doenças Profissionais/etiologia , Onicomicose/etiologia , Aves Domésticas , Fatores de Risco , Fatores Sexuais , Tinha dos Pés/etiologia , Adulto Jovem
16.
J Perinatol ; 44(3): 428-433, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37932405

RESUMO

OBJECTIVE: Determine recurrent neonatal acute kidney injury (rAKI) incidence, risk factors, and associated outcomes. STUDY DESIGN: Single-center retrospective cohort of neonates admitted to the NICU 1/1/20-6/30/21. Comparisons were made between those with no AKI, single AKI episode (sAKI), and rAKI. Multivariable linear and logistic regression models were used to assess associations between rAKI and length of mechanical ventilation (LMV), length of hospitalization stay (LOS), mortality, and hypertension (HTN) at discharge. RESULTS: The incidence of AKI in the cohort of 869 infants was 19%: 705 (81%) no AKI, 100 (12%) sAKI, 64 (7%) rAKI. Both sAKI and rAKI were independently associated with longer LMV and LOS. sAKI was independently associated with almost 4x higher odds of mortality than rAKI. CONCLUSION: In this single center cohort of neonates, sAKI independently predicts mortality, however rAKI is independently associated with increased LMV and LOS suggesting rAKI is clinically important and warrants further study.


Assuntos
Injúria Renal Aguda , Unidades de Terapia Intensiva Neonatal , Recém-Nascido , Lactente , Humanos , Incidência , Estudos Retrospectivos , Tempo de Internação , Fatores de Risco , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/terapia
17.
J Perinatol ; 2024 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-38783049

RESUMO

OBJECTIVE: The relationship between adrenal insufficiency (AI), post-natal steroids (PNS) and neonatal acute kidney injury (AKI) remains understudied. We investigated associations between PNS and AKI in very low birthweight (VLBW) neonates, hypothesizing PNS is associated with reduced AKI. STUDY DESIGN: We conducted a single-center retrospective review of VLBW infants comparing those with and without PNS exposure. Associations between PNS exposure and AKI were evaluated using generalized linear mixed-modeling adjusted for confounders. RESULT: Of 567 neonates, 97 (17.1%) were exposed to PNS and 130 (22.9%) experienced AKI. Infants with PNS had lower gestational age, birthweight, Apgar scores, and experienced more AI versus those without PNS (all p < 0.05). PNS was associated with AKI (aRR 1.72, 95% CI 1.09-2.72) though hydrocortisone alone was not. CONCLUSION: PNS exposure, but not hydrocortisone alone, is associated with increased AKI in VLBW neonates. Further analysis is needed to investigate the role of AI and AKI.

18.
Mil Med ; 189(3-4): e766-e772, 2024 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-37738176

RESUMO

INTRODUCTION: Narcissism has been studied for its role in leadership using various versions of the Narcissistic Personality Inventory (NPI). Narcissism is described as having a "dark and negative" side as well as a "positive or bright" side. The bright side of narcissism, in particular, has been studied for its role in leadership. In studies among military personnel in Finland and Hungary, the NPI has been associated with positive leadership traits. We assessed if measures of narcissistic personality were predictive of entrance to and graduation from the Army Ranger Course among United States (U.S.) Army personnel. MATERIALS AND METHODS: We included the NPI as one of the measures in the Ranger Resilience and Improved Performance on Phospholipid-bound Omega-3's (RRIPP-3) study. RRIPP-3 was a double-blind, placebo-controlled dietary supplement intervention trial at Fort Benning, GA, that enrolled 555 officers when they entered the U.S. Army Infantry Basic Officer Leadership Course (IBOLC) with the intention to complete the U.S. Ranger School. RRIPP-3 volunteer participants consumed eight dietary supplements daily containing 2.3 g of omega-3 (krill oil) or macadamia nut oil (control) over a 20-week period. Blood spot samples were collected to monitor intake compliance. Cognitive functioning, resilience, and mood were assessed at approximately 14 and 16 weeks. Dietary intake was also assessed. The 40-item, forced-choice NPI was included to assess if three factors of narcissism: Leadership/Authority, Grandiose/Exhibitionism, and Entitlement/Exploitativeness measures of narcissistic personality were associated with entrance to and graduation from the Army Ranger Course. RESULTS: Of the 555 soldiers enrolled in RRIPP-3, there were no statistically significant differences in the total NPI scores comparing U.S. Army IBOLC officers who enrolled (n = 225) versus did not enroll (n = 330, p = .649) or graduated (n = 95; versus did not graduate [n = 460, p = .451]) from the Ranger Course. None of the three-factor NPI subscales differed statistically comparing either enrollment in (p = .442, .510, and .589, respectively) or graduation from the Ranger Course (p = .814, .508, and .813, respectively). CONCLUSIONS: Although narcissism has been positively associated with military trainee success in other countries, we did not find an association between narcissism and trainee success among U.S. Army trainees, and accordingly the level of narcissism did not predict trainee success or failure.


Assuntos
Militares , Humanos , Liderança , Narcisismo , Transtornos da Personalidade/psicologia , Inventário de Personalidade , Estados Unidos , Método Duplo-Cego
19.
J Neuromuscul Dis ; 11(2): 389-410, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38250781

RESUMO

Background: Dysphagia is common in adults living with neuromuscular disease (NMD). Increased life expectancy, secondary to improvements in standards of care, requires the recognition and treatment of dysphagia with an increased priority. Evidence to support the establishment of healthcare pathways is, however, lacking. The experiences of people living with NMD (pplwNMD) and their caregivers are valuable to guide targeted, value-based healthcare. Objective: To generate preliminary considerations for neuromuscular dysphagia care and future research in the United Kingdom, based on the experiences of those living with, or caring for, people with NMD. Methods: Two surveys (one for adults living with NMD and dysphagia, and a second for caregivers) were co-designed with an advisory group of people living with NMD. Surveys were electronically distributed to adults living with NMD and their caregivers between 18th May and 26th July 2020. Distribution was through UK disease registries, charity websites, newsletters, and social media. Results: Adults living with NMD receive little information or education that they are likely to develop swallowing difficulties. Most respondents report wanting this information prior to developing these difficulties. Difficulties with swallowing food and medication are common in this group, and instrumental assessment is considered a helpful assessment tool. Both adults living with NMD and caregivers want earlier access to neuromuscular swallowing specialists and training in how best to manage their difficulties. Conclusions: Improvement is needed in the dysphagia healthcare pathway for adults living with NMD to help mitigate any profound physical and psychological consequences that may be caused by dysphagia. Education about swallowing difficulties and early referral to a neuromuscular swallowing specialist are important to pplwNMD and their caregivers. Further research is required to better understand the experiences of pplwNMD and their caregivers to inform the development of dysphagia healthcare pathways.


Assuntos
Transtornos de Deglutição , Doenças Neuromusculares , Adulto , Humanos , Transtornos de Deglutição/etiologia , Cuidadores , Doenças Neuromusculares/complicações , Reino Unido , Inquéritos e Questionários
20.
J Perinatol ; 43(11): 1413-1419, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37479886

RESUMO

OBJECTIVE: To determine the association of maternal pre-pregnancy body mass index (BMI) and neurodevelopmental impairment (NDI) at 18-24 months corrected age (CA) in infants born < 29 weeks gestation. STUDY DESIGN: Infants born between 2005 and 2015 at < 29 weeks gestation were included. BMI was categorized into BMI1 [18.5-24.9 kg/m2], BMI2 [25-29.9 kg/m2], BMI3 [ ≥ 30 kg/m2]. Primary outcome was death or NDI (Bayley-III scores < 85, cerebral palsy, hearing or visual impairment). Univariate and multivariate analysis were used. RESULTS: There were 315 infants in BMI1, 235 in BMI2, and 147 in BMI3 groups. Adjusted odds ratio (aOR) of death or NDI in BMI2 vs. BMI1 and BMI3 vs BMI1 groups were 1.33 (95% CI 0.86-2.06) and 0.76 (95% CI 0.47-1.22). Adjusted odds ratio of Bayley-III language composite < 85 was 2.06 (95% CI 1.28-3.32). CONCLUSION: Pre-pregnancy BMI was not associated with death or NDI in extremely preterm infants. Infants born to overweight mothers had higher odds of low language scores.


Assuntos
Paralisia Cerebral , Transtornos do Neurodesenvolvimento , Lactente , Gravidez , Feminino , Recém-Nascido , Humanos , Sobrepeso/complicações , Sobrepeso/epidemiologia , Lactente Extremamente Prematuro , Idade Gestacional , Paralisia Cerebral/epidemiologia , Transtornos do Neurodesenvolvimento/epidemiologia , Transtornos do Neurodesenvolvimento/etiologia , Estudos Retrospectivos
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