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2.
N Engl J Med ; 380(23): 2215-2224, 2019 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-31167051

RESUMO

BACKGROUND: We previously reported that a median of 5.6 years of intensive as compared with standard glucose lowering in 1791 military veterans with type 2 diabetes resulted in a risk of major cardiovascular events that was significantly lower (by 17%) after a total of 10 years of combined intervention and observational follow-up. We now report the full 15-year follow-up. METHODS: We observationally followed enrolled participants (complete cohort) after the conclusion of the original clinical trial by using central databases to identify cardiovascular events, hospitalizations, and deaths. Participants were asked whether they would be willing to provide additional data by means of surveys and chart reviews (survey cohort). The prespecified primary outcome was a composite of major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, new or worsening congestive heart failure, amputation for ischemic gangrene, and death from cardiovascular causes. Death from any cause was a prespecified secondary outcome. RESULTS: There were 1655 participants in the complete cohort and 1391 in the survey cohort. During the trial (which originally enrolled 1791 participants), the separation of the glycated hemoglobin curves between the intensive-therapy group (892 participants) and the standard-therapy group (899 participants) averaged 1.5 percentage points, and this difference declined to 0.2 to 0.3 percentage points by 3 years after the trial ended. Over a period of 15 years of follow-up (active treatment plus post-trial observation), the risks of major cardiovascular events or death were not lower in the intensive-therapy group than in the standard-therapy group (hazard ratio for primary outcome, 0.91; 95% confidence interval [CI], 0.78 to 1.06; P = 0.23; hazard ratio for death, 1.02; 95% CI, 0.88 to 1.18). The risk of major cardiovascular disease outcomes was reduced, however, during an extended interval of separation of the glycated hemoglobin curves (hazard ratio, 0.83; 95% CI, 0.70 to 0.99), but this benefit did not continue after equalization of the glycated hemoglobin levels (hazard ratio, 1.26; 95% CI, 0.90 to 1.75). CONCLUSIONS: Participants with type 2 diabetes who had been randomly assigned to intensive glucose control for 5.6 years had a lower risk of cardiovascular events than those who received standard therapy only during the prolonged period in which the glycated hemoglobin curves were separated. There was no evidence of a legacy effect or a mortality benefit with intensive glucose control. (Funded by the VA Cooperative Studies Program; VADT ClinicalTrials.gov number, NCT00032487.).


Assuntos
Glicemia/análise , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Diabetes Mellitus Tipo 2/sangue , Feminino , Seguimentos , Humanos , Hiperglicemia/prevenção & controle , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Veteranos
3.
J Neurosurg ; : 1-9, 2019 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-30952118

RESUMO

Objective: Several randomized studies have compared the effect of deep brain stimulation (DBS) of the subthalamic nucleus with the best medical treatment in large groups of patients. Important outcome measures differ between studies. Two such major studies, the life-quality study of the German Competence Network for Parkinson's disease (LQ study) and the US Veterans Affairs/National Institute of Neurological Disorders and Stroke trial (VA/NINDS trial), were compared here in order to understand their differences in outcomes. Methods: Unless otherwise noted, analyses were based on those subjects in each study who received a DBS implant (LQ study 76 patients, VA/NINDS trial 140 patients) and who had data for the measurement under consideration (i.e., no imputations for missing data), referred to hereafter as the "as-treated completers" (LQ 69 patients, VA/NINDS 125 patients). Data were prepared and analyzed by biostatisticians at the US Department of Veterans Affairs Cooperative Studies Program Coordinating Center, the Coordinating Center for Clinical Trials Marburg, and Medtronic, under the direction of two authors (G.D. and K.A.F.). Data were extracted from the respective databases into SAS data sets and analyzed using SAS software. Analyses were based on the 6-month follow-up data from both studies because this was the endpoint for the LQ study. Results: Pre-DBS baseline demographics differed significantly between the studies, including greater levodopa responsiveness (LDR) in the LQ study population than in the VA/NINDS group. After DBS, LQ subjects demonstrated greater improvement in motor function (Unified Parkinson's Disease Rating Scale, Motor Examination [UPDRS-III]), activities of daily living (ADLs), and complications of therapy. Medication reduction and improvements in life quality other than ADLs were not significantly different between LQ and VA/NINDS subjects. When the two populations were compared according to pre-DBS LDR, the "full responders" to levodopa (≥ 50% improvement on UPDRS-III with medication) in the two studies showed no significant difference in motor improvement with DBS (LQ 18.5 ± 12.0­point improvement on UPDRS-III vs VA/NINDS 17.7 ± 15.6­point improvement, p = 0.755). Among levodopa full responders, ADLs improved slightly more in the LQ group, but scores on other UPDRS subscales and the Parkinson's Disease Questionnaire-39 were not significantly different between the two studies. Conclusions: This comparison suggests that patient selection criteria, especially preoperative LDR, are the most important source of differences in motor outcomes and quality of life between the two studies. Abbreviations: ADL = activity of daily living; DBS = deep brain stimulation; HY = Hoehn and Yahr; L-dopa = levodopa; LDR = levodopa responsiveness; LED = levodopa equivalent dose; LQ study = German Competence Network for Parkinson's disease study; PD = Parkinson's disease; PDQ-39 = 39-Item Parkinson's Disease Questionnaire; PDQ-SI = PDQ summary index; STN = subthalamic nucleus; UPDRS-II = Unified Parkinson's Disease Rating Scale, Activities of Daily Living; UPDRS-III = UPDRS Motor Examination; UPDRS-IV = UPDRS Complications of Therapy; VA/NINDS = Veterans Affairs/National Institute of Neurological Disorders and Stroke.

4.
Psychiatry Res ; 275: 287-295, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30953873

RESUMO

Veterans' spouses are at risk for mental distress and substance use. We examined long term psychological functioning in spouses from a national cohort of 1991 Gulf War era veterans. From clinical interviews, spouses of deployed veterans (n = 488) did not have a greater prevalence of post-war mental disorders compared to spouses of non-deployed veterans (n = 536); however, in couples that were living together since the war, there was an increased risk of anxiety disorders or any one disorder. On questionnaires, the impact varied but was most consistently observed in more severe depression and greater functional impairment in spouses of deployed compared to non-deployed veterans. If a veteran developed post-war anxious/depressive disorders or any one mental disorder, the matched spouse was more likely to develop post-war anxious/depressive disorders or any one mental disorder, respectively. Veteran combat exposure did not similarly increase the risk of spouse post-war mental disorders. Greater spouse self-reported symptomatology was observed in spouses of veterans with anxious/depressive disorders even when controlling for deployment. In summary, the war conferred greater risk for spouse mental disorders and distress for spouses of veterans with mental health disorders, with some increased risk for spouses of deployed veterans, especially in couples together since the war.

5.
Lung ; 197(2): 181-188, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30739217

RESUMO

BACKGROUND: During exercise-training patients with chronic obstructive pulmonary disease (COPD) can entrain their breathing pattern to visual-feedback cues as to achieve a slower respiratory rate and prolong exhalation. The result is an improvement in exercise tolerance and a reduction in dynamic hyperinflation. Acoustic stimuli, including metronome-generated acoustic stimuli, can entrain human movements. Accordingly, we hypothesized that exercise duration and dynamic hyperinflation would be less after exercise-training plus breathing-retraining using a metronome-based acoustic-feedback system than after exercise-training alone. METHODS: Of 205 patients with COPD [FEV1 = 44 ± 16% predicted (± SD)] recruited, 119 were randomly assigned to exercise-training plus breathing-retraining using acoustic feedback (n = 58) or exercise-training alone (n = 61). Patients exercised on a treadmill thrice-weekly for 12 weeks. Before and at completion of training, patients underwent constant-load treadmill testing with inspiratory capacity measures every 2 min. RESULTS: At completion of training, improvements in exercise duration in the breathing-retraining plus exercise-training and exercise-training alone groups were similar (p = 0.35). At isotime, inspiratory capacity increased (less exercise-induced dynamic hyperinflation) by 3% (p = 0.001) in the breathing-retraining plus exercise-training group and remained unchanged in the exercise-alone group. The between-group change in inspiratory capacity, however, was not significant (p = 0.08). CONCLUSIONS: In patients with COPD, breathing-retraining using a metronome-based acoustic feedback did not result in improved exercise endurance or decreased dynamic hyperinflation when compared to exercise-training alone. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT NCT01009099; URL: http://www.clinicaltrials.gov.

6.
Am J Med ; 132(4): 510-518, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30576630

RESUMO

BACKGROUND: Chronic multisymptom illness (CMI) is more prevalent among deployed than nondeployed veterans from the first Gulf War. Objective physiologic markers of CMI are lacking. The purpose of this study is to determine whether measurable abnormalities in the autonomic nervous system or hypothalamic-pituitary adrenal axis would distinguish CMI cases (CMI+) from controls (CMI-) among deployed veterans of the 1990-1991 Gulf War. METHODS: This is a cross-sectional case-control cohort study that examined deployed veterans who participated in the Phase III study: National Health Survey of Gulf War Veterans and Their Families. Autonomic nervous system and hypothalamic-pituitary adrenal axis function-related measures included: 24-hour heart-rate variability, urinary catecholamines and cortisol, hypertension, insulin sensitivity, dyslipidemia, body fat, bone mineral density, and ultrasensitive C-reactive protein. RESULTS: Veterans of the first Gulf War with CMI (n = 73) and without the condition (n = 111) were studied. Sociodemographic characteristics were similar. Veterans with CMI reported poorer mental and physical functioning, greater use of prescription medications, and more nonroutine clinic visits. These veterans were also more likely to have fibromyalgia syndrome, irritable bowel syndrome, metabolic syndrome, and among males, a larger waist-to-hip ratio. Lower values for a nonlinear heart-rate-variability parameter-the short-term fractal scaling exponent (DFA1), reflecting an increased randomness of beat-to-beat changes in heart rate-were observed in veterans with CMI than those veterans without it (1.28±0.16vs 1.35±0.15; p=0.005). Hypothalamic-pituitary-adrenal axis function measures were similar between the two groups. CONCLUSION: In this cohort of deployed veterans from the first Gulf War, we identified abnormal heart-rate variability in veterans with CMI compared to veterans without the condition, which suggests abnormal functioning of the autonomic nervous system and possible long-term cardiovascular effects.

7.
Diabetes Care ; 2018 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-30455335

RESUMO

OBJECTIVE: To determine the risk factors for severe hypoglycemia and the association between severe hypoglycemia and serious cardiovascular adverse events and cardiovascular and all-cause mortality in the Veterans Affairs Diabetes Trial (VADT). RESEARCH DESIGN AND METHODS: This post hoc analysis of data from the VADT included 1,791 military veterans (age 60.5 ± 9.0 years) with suboptimally controlled type 2 diabetes (HbA1c 9.4 ± 2.0%) of 11.5 ± 7.5 years disease duration with or without known cardiovascular disease and additional cardiovascular risk factors. Participants were randomized to intensive (HbA1c <7.0%) versus standard (HbA1c <8.5%) glucose control. RESULTS: The rate of severe hypoglycemia in the intensive treatment group was 10.3 per 100 patient-years compared with 3.7 per 100 patient-years in the standard treatment group (P < 0.001). In multivariable analysis, insulin use at baseline (P = 0.02), proteinuria (P = 0.009), and autonomic neuropathy (P = 0.01) were independent risk factors for severe hypoglycemia, and higher BMI was protective (P = 0.017). Severe hypoglycemia within the past 3 months was associated with an increased risk of serious cardiovascular events (P = 0.032), cardiovascular mortality (P = 0.012), and total mortality (P = 0.024). However, there was a relatively greater increased risk for total mortality in the standard group compared with the intensive group (P = 0.019). The association between severe hypoglycemia and cardiovascular events increased significantly as overall cardiovascular risk increased (P = 0.012). CONCLUSIONS: Severe hypoglycemic episodes within the previous 3 months were associated with increased risk for major cardiovascular events and cardiovascular and all-cause mortality regardless of glycemic treatment group assignment. Standard therapy further increased the risk for all-cause mortality after severe hypoglycemia.

8.
J Occup Environ Med ; 2018 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-30489351

RESUMO

OBJECTIVE: The aim of the study was to examine the prevalence of birth defects among children born to Gulf War veterans. METHODS: 788 singleton children born after the war to 522 veterans (262 Gulf War-deployed, DV; 260 non-deployed, NDV) underwent physical examinations focusing on major and minor birth defects and other findings. RESULTS: We found no differences between children of DV and NDV in the prevalence of major birth defects or other findings. However, children of DV females were more likely to have minor birth defects compared to children of NDV females (DV 22% NDV 4.8%, OR:5.47, CI: 2.06,14.55), mainly due to increased incidence of minor eye and musculoskeletal birth defects. CONCLUSIONS: Our data show that deployment of females to the Persian Gulf arena was associated with increased risk of minor birth defects in their offspring.

9.
Neurology ; 91(3): e258-e267, 2018 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-29950436

RESUMO

OBJECTIVE: To assess the reliability and usefulness of an EEG-based brain-computer interface (BCI) for patients with advanced amyotrophic lateral sclerosis (ALS) who used it independently at home for up to 18 months. METHODS: Of 42 patients consented, 39 (93%) met the study criteria, and 37 (88%) were assessed for use of the Wadsworth BCI. Nine (21%) could not use the BCI. Of the other 28, 27 (men, age 28-79 years) (64%) had the BCI placed in their homes, and they and their caregivers were trained to use it. Use data were collected by Internet. Periodic visits evaluated BCI benefit and burden and quality of life. RESULTS: Over subsequent months, 12 (29% of the original 42) left the study because of death or rapid disease progression and 6 (14%) left because of decreased interest. Fourteen (33%) completed training and used the BCI independently, mainly for communication. Technical problems were rare. Patient and caregiver ratings indicated that BCI benefit exceeded burden. Quality of life remained stable. Of those not lost to the disease, half completed the study; all but 1 patient kept the BCI for further use. CONCLUSION: The Wadsworth BCI home system can function reliably and usefully when operated by patients in their homes. BCIs that support communication are at present most suitable for people who are severely disabled but are otherwise in stable health. Improvements in BCI convenience and performance, including some now underway, should increase the number of people who find them useful and the extent to which they are used.

10.
JAMA Ophthalmol ; 136(5): 524-531, 2018 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29800250

RESUMO

Importance: Examining costs and consequences of different low-vision (LV) programs provides important information about resources needed to expand treatment options efficiently. Objective: To examine the costs and consequences of LV rehabilitation or basic LV services. Design, Setting, and Participants: The US Department of Veterans Affairs (VA) Low Vision Intervention Trial (LOVIT) II was conducted from September 27, 2010, to July 31, 2014, at 9 VA facilities and included 323 veterans with macular diseases and a best-corrected distance visual acuity of 20/50 to 20/200. Veterans were randomized to receive basic LV services that provided LV devices without therapy, or LV rehabilitation that added a therapist to LV services who provided instruction and homework on using LV devices, eccentric viewing, and environmental modification. We compared costs and consequences between these groups. Interventions: Low-vision devices without therapy and LV devices with therapy. Main Outcomes and Measures: Costs of providing basic LV services or LV rehabilitation were assessed. We measured consequences as changes in functional visual ability from baseline to follow-up 4 months after randomization using the VA Low Vision Visual Functioning Questionnaire. Visual ability was measured in dimensionless log odds units (logits). Results: Of 323 randomized patients, the mean (SD) age was 80 (10.5) years, 314 (97.2%) were men, and 292 (90.4%) were white. One hundred sixty (49.5%) received basic LV services and 163 (50.1%) received LV rehabilitation. The mean (SD) total direct health care costs per patient were similar between patients who were randomized to receive basic LV services ($1662 [$671]) or LV rehabilitation ($1788 [$864]) (basic LV services, $126 lower; 95% CI, $299 lower to $35 higher; P = .15). However, basic LV services required less time and had lower transportation costs. Patients receiving LV rehabilitation had greater improvements in overall visual ability, reading ability, visual information processing, and visual motor skill scores.

11.
JAMA Otolaryngol Head Neck Surg ; 144(2): 156-163, 2018 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-29270612

RESUMO

Importance: Benign vocal fold nodules affect 12% to 22% of the pediatric population, and 95% of otolaryngologists recommend voice therapy as treatment. However, no randomized clinical trials that we are aware of have shown its benefits. Objective: To determine the impact of voice therapy in children with vocal fold nodules according to pretherapy and posttherapy scores on the Pediatric Voice-Related Quality of Life (PVRQOL) survey; secondary objectives included changes in phonatory parameters. Design, Setting, and Participants: For this multicenter randomized clinical trial, 114 children ages 6 to 10 years with vocal fold nodules, PVRQOL scores less than 87.5, and dysphonia for longer than 12 weeks were recruited from outpatient voice and speech clinics. This age range was identified because these patients have not experienced pubertal changes of the larynx, tolerate stroboscopy, and cooperate with voice therapy. Participants were blinded to treatment arm. Interventions: Participants received either indirect or direct therapy for 8 to 12 weeks. Indirect therapy focused on education and discussion of voice principles, while direct treatment used the stimulus, response, antecedent paradigm. Main Outcomes and Measures: The primary outcome measure was PVRQOL score change before and after treatment. Secondary phonatory measures were also compared. Results: Overall, 114 children were recruited for study (mean [SD] age, 8 [1.4] years; 83 males [73%]); with 57 randomized to receive either indirect or direct therapy. Both direct and indirect therapy approaches showed significant differences in PVRQOL scores pretherapy to posttherapy. The mean increase in PVRQOL score for direct therapy was 19.2, and 14.7 for indirect therapy (difference, 4.5; 95.3% CI, -10.8 to 19.8). Of 44 participants in the direct therapy group, 27 (61%) achieved a clinically meaningful PVRQOL improvement, compared with 26 of 49 (53%) for indirect therapy (difference, 8%; 95% CI, -12 to 28). Post hoc stratification showed robust effects in the direct therapy group for older children (Cohen d = 0.50) and the latter two-thirds of participants (Cohen d = 0.46). Vocal fold nodules reduced in size in 31% (22 of 70) and completely resolved in 11% (8 of 70) of participants who consented to a second set of images after going through the recruitment process. Conclusions and Relevance: Both direct and indirect voice therapy improved voice-related quality of life in children with vocal fold nodules, although there was no significant difference between approaches. Future studies may focus upon which voice therapy approaches are effective in treating age-defined populations. Trial Registration: clinicaltrials.gov Identifier: NCT01255735.

12.
Diabetologia ; 61(2): 295-299, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29101421

RESUMO

AIMS/HYPOTHESIS: We conducted an analysis of data collected during the Veterans Affairs Diabetes Trial (VADT) and the follow-up study (VADT-F) to determine whether intensive (INT) compared with standard (STD) glycaemic control during the VADT resulted in better long-term kidney outcomes. METHODS: VADT randomly assigned 1791 veterans from 20 Veterans Affairs (VA) medical centres who had type 2 diabetes mellitus and a mean HbA1c of 9.4 ± 2% (79.2 mmol/mol) at baseline to receive either INT or STD glucose control for a median of 5.6 years (randomisation December 2000 to May 2003; intervention ending in May 2008). After the trial, participants received routine care through their own physicians within the VA. This is an interim analysis of the VADT-F (June 2008 to December 2013). We collected data using VA and National databases and report renal outcomes based on serum creatinine, eGFR and urine albumin to creatinine ratio (ACR) in 1033 people who provided informed consent to participate in the VADT-F. RESULTS: By the end of the VADT-F, significantly more people who received INT treatment during the VADT maintained an eGFR >60 ml min-1 1.73 m-2 (OR 1.34 [95% CI 1.05, 1.71], p = 0.02). This benefit was most evident in those who were classified as at moderate risk (INT vs STD, RR 1.3, p = 0.03) or high risk (RR 2.3, p = 0.04) of chronic kidney disease on the Kidney Disease Improving Global Outcomes (KDIGO-CKD) at the beginning of VADT. At the end of VADT-F, significantly more people from the INT group improved to a low KDIGO risk category (RR 6.1, p = 0.002). During the VADT-F there were no significant differences between INT and STD for average HbA1c, blood pressure or lipid levels. CONCLUSIONS/INTERPRETATION: After just over 11 years of follow-up, there was a 34% greater odds of maintaining an eGFR of >60 ml min-1 1.73 m-2 and of improving the KDIGO category in individuals with type 2 diabetes who had received INT for a median of 5.6 years. VADT clinical trials.gov number: NCT 00032487.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Rim/fisiopatologia , Glicemia/efeitos dos fármacos , Creatinina/urina , Diabetes Mellitus Tipo 2/sangue , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/metabolismo , Feminino , Seguimentos , Taxa de Filtração Glomerular/efeitos dos fármacos , Hemoglobina A Glicada/metabolismo , Humanos , Insulina/uso terapêutico , Rim/efeitos dos fármacos , Rim/metabolismo , Masculino , Albumina Sérica Humana/urina , Resultado do Tratamento , Veteranos
13.
Mil Med ; 182(5): e1648-e1656, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-29087907

RESUMO

OBJECTIVE: In 1995, the Centers for Disease Control and Prevention defined chronic multisymptom illness (CMI), a symptom complex in deployed veterans (DVs) of the 1991 Gulf War 1. The specific aim of this work is to determine the prevalence of CMI in spouses of DV and nondeployed veterans (NDVs) and whether veteran CMI is associated with spouse CMI, and to describe the physical and psychological profile of spouses with CMI. MATERIALS AND METHODS: To determine whether veteran CMI was associated with CMI in their spouses, we used retrospective data from the "National Health Survey of Gulf War Veterans and Their Families." Cross-sectional data were collected from spouses of veterans enrolled in the study, including those of 482 DVs and 532 NDVs who participated in an in-person examination between 1999 and 2001. In addition to a physical examination, this study evaluated health-related quality of life (Medical Outcomes Study Short-Form 36, SF-36), psychological symptoms, and post-traumatic stress disorder (PTSD) status, and measured a variety of common laboratory tests. Statistical analyses included Fisher's Exact Test (or Mantel-Haenszel χ2 test for linear trend) as well as odds ratios (ODs) and 95% confidence intervals (CIs) for categorical data. For continuous outcomes, two-sample t-tests were used to compare mean responses among spouses of DV and NDV with and without CMI, and between spouses of DV and NDV with CMI only. Logistic or linear regression models were developed for multiple-covariate analysis to assess if any of the associations we found in the unadjusted analyses would change. The project was approved by the Hines Cooperative Studies Program Human Rights Committee, the Institutional Review Boards at each participating site, and the Brockton VAMC. RESULTS: The prevalence of CMI in spouses was 19.5% (DV) and 17.3% (NDV) (odds ratio [OR]: 1.16; 95% confidence interval [CI]: 0.84, 1.59). Spouses were more likely to have CMI if their veteran partner had CMI (OR: 1.49; 95% CI: 1.01, 2.19) or PTSD (OR: 1.84; 95% CI: 1.01, 3.37). Deployment was not a predictor of CMI. Spouses with CMI reported poorer SF-36 physical and mental component scores; worse symptoms of depression, anxiety, and post-traumatic stress; and a higher percentage had probable PTSD, more nonroutine clinic visits, more hospitalization, more prescription medications, and more psychotropic medication use compared with spouses without CMI regardless of the deployment status of their veteran spouses. CONCLUSION: Spouses of veterans with CMI report worse physical and mental functioning than spouses of veterans without CMI, regardless of the veteran's deployment status. Strengths of the study include that all participants were selected independently of veteran medical or psychiatric illness, and all underwent comprehensive health assessments. Weaknesses of the study include that data were not collected blindly, and that we made minor modifications of the Centers for Disease Control and Prevention diagnosis, such as defining fatigue and musculoskeletal pain more restrictively. The impact of veteran CMI on their spouse's health is likely to be significant in terms of medical cost and morbidity. Efforts to reduce the impact of CMI in the future should include identifying soldiers who are more vulnerable, such as those with prior GWI or PTSD.


Assuntos
Doença Crônica/epidemiologia , Cônjuges/psicologia , Adulto , Estudos de Coortes , Estudos Transversais , Fadiga/epidemiologia , Fadiga/etiologia , Feminino , Guerra do Golfo , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Dor Musculoesquelética/epidemiologia , Dor Musculoesquelética/etiologia , Síndrome do Golfo Pérsico/complicações , Síndrome do Golfo Pérsico/epidemiologia , Prevalência , Psicometria/instrumentação , Psicometria/métodos , Qualidade de Vida/psicologia , Autorrelato , Cônjuges/estatística & dados numéricos , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Inquéritos e Questionários , Estados Unidos/epidemiologia , Veteranos/estatística & dados numéricos
14.
Am J Nephrol ; 44(1): 54-62, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27385652

RESUMO

BACKGROUND: Patients with type 2 diabetes mellitus (DM), obesity, and chronic kidney disease (CKD) are generally physically inactive and may benefit from exercise. Our objective was to determine the effects of structured exercise on physical fitness, kidney function, endothelial function, inflammation, and body composition in such patients. METHODS: In this randomized, controlled trial, 36 male patients (age 49-81) were randomly assigned to exercise + diet management (n = 18) or diet alone (n = 18). Participants were eligible if they had type 2 DM, body mass index >30 kg/m2, CKD stages 2-4, and persistent proteinuria (>200 mg/g creatinine for >3 months). The exercise intervention was a 12-week (3 days per week) program of aerobic and resistance training followed by 40 weeks of home exercise. The primary outcome measure was change from baseline in urine protein to creatinine ratio (UPCR) at 12 and 52 weeks. RESULTS: Thirty-two participants completed the study (14 exercise + diet, 18 diet-alone group). The change from baseline in UPCR was slightly greater in the diet-alone group at 12 weeks but not at 52 weeks. Changes in both symptom-limited and constant-workrate treadmill times were significantly higher in the exercise + diet group at 12 weeks but not at 52 weeks. There were no significant differences in urine albumin to creatinine ratio, estimated glomerular filtration rate, endothelial function, inflammation, or body composition between the groups. CONCLUSIONS: In obese diabetic subjects with CKD, structured exercise improved exercise capacity but not body composition or renal function. This is a work of the US Government and is not subject to copyright protection in the USA. Foreign copyrights may apply. Published by S. Karger AG, Basel.


Assuntos
Diabetes Mellitus Tipo 2/terapia , Obesidade/terapia , Proteinúria/terapia , Insuficiência Renal Crônica/complicações , Treinamento de Resistência , Idoso , Idoso de 80 Anos ou mais , Diabetes Mellitus Tipo 2/complicações , Exercício , Tolerância ao Exercício , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Proteinúria/complicações
15.
JAMA Dermatol ; 151(12): 1323-1329, 2015 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-26375589

RESUMO

Importance: The costs and utility of teledermatology are important features of implementation. Such an analysis requires a description of the perspective of the entity that will bear the cost. Objective: To assess the costs and utility of a store-and-forward teledermatology referral process compared with a conventional referral process from the perspectives of the Department of Veterans Affairs (VA) and society. Design, Setting, and Participants: Three hundred ninety-one randomized participants were referred from remote sites of primary care to the dermatology services of 2 VA medical facilities for ambulatory skin conditions from December 2008 through June 2010, and follow-up was completed in March 2011. The time trade-off utility measures and costs were collected during a 9-month period among participants in a 2-site parallel group randomized clinical trial. The perspectives of the VA and society were evaluated. The multiple imputation procedure or weighted means were used for missing data elements. Data were analyzed from January to July 2014. Interventions: Referrals were managed using store-and-forward teledermatology or a conventional text-based referral process. Main Outcomes and Measures: Total costs from the perspectives of the VA and society incurred during the 9-month follow-up were used to derive per-participant costs. Utility, using the time trade-off method, was the measure of effectiveness. Results: From the VA perspective, the total cost for conventional referrals was $66 145 (minimum, $58 697; maximum, $71 635), or $338 (SD, $291) per participant (196 participants); the total cost for teledermatology referrals was $59 917 (mimimum, $51 794; maximum, $70 398), or $308 (SD, $298) per participant (195 participants). The $30 difference in per-participant cost was not statistically significant (95% CI, -$79 to $20). From the societal perspective, the total cost for conventional referrals was $106 194 (minimum, $98 746; maximum, $111 684), or $542 (SD, $403) per participant (196 participants); the total cost for teledermatology referrals was $89 523 (minimum, $81 400; maximum, $100 400) or $460 (SD, $428) per participant. This $82 difference in per-participant cost was statistically significant (95% CI, -$12 to -$152). From baseline to the 9-month follow-up, the time trade-off utility value improved by 0.02 in the conventional referral group and 0.03 in the teledermatology group. This difference was not statistically significant (P = .50). Conclusions and Relevance: Compared with conventional referrals, store-and-forward teledermatology referrals were performed at a comparable cost (VA perspective) or at a lower cost (societal perspective) with no evidence of a difference in utility as measured by the time trade-off method. Trial Registration: clinicaltrials.gov Identifier: NCT00488293.

16.
N Engl J Med ; 372(23): 2197-206, 2015 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-26039600

RESUMO

BACKGROUND: The Veterans Affairs Diabetes Trial previously showed that intensive glucose lowering, as compared with standard therapy, did not significantly reduce the rate of major cardiovascular events among 1791 military veterans (median follow-up, 5.6 years). We report the extended follow-up of the study participants. METHODS: After the conclusion of the clinical trial, we followed participants, using central databases to identify procedures, hospitalizations, and deaths (complete cohort, with follow-up data for 92.4% of participants). Most participants agreed to additional data collection by means of annual surveys and periodic chart reviews (survey cohort, with 77.7% follow-up). The primary outcome was the time to the first major cardiovascular event (heart attack, stroke, new or worsening congestive heart failure, amputation for ischemic gangrene, or cardiovascular-related death). Secondary outcomes were cardiovascular mortality and all-cause mortality. RESULTS: The difference in glycated hemoglobin levels between the intensive-therapy group and the standard-therapy group averaged 1.5 percentage points during the trial (median level, 6.9% vs. 8.4%) and declined to 0.2 to 0.3 percentage points by 3 years after the trial ended. Over a median follow-up of 9.8 years, the intensive-therapy group had a significantly lower risk of the primary outcome than did the standard-therapy group (hazard ratio, 0.83; 95% confidence interval [CI], 0.70 to 0.99; P=0.04), with an absolute reduction in risk of 8.6 major cardiovascular events per 1000 person-years, but did not have reduced cardiovascular mortality (hazard ratio, 0.88; 95% CI, 0.64 to 1.20; P=0.42). No reduction in total mortality was evident (hazard ratio in the intensive-therapy group, 1.05; 95% CI, 0.89 to 1.25; P=0.54; median follow-up, 11.8 years). CONCLUSIONS: After nearly 10 years of follow-up, patients with type 2 diabetes who had been randomly assigned to intensive glucose control for 5.6 years had 8.6 fewer major cardiovascular events per 1000 person-years than those assigned to standard therapy, but no improvement was seen in the rate of overall survival. (Funded by the VA Cooperative Studies Program and others; VADT ClinicalTrials.gov number, NCT00032487.).


Assuntos
Glicemia/metabolismo , Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus Tipo 2/sangue , Hemoglobina A Glicada/análise , Hipoglicemiantes/administração & dosagem , Idoso , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/mortalidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Risco , Análise de Sobrevida
17.
Neurorehabil Neural Repair ; 29(6): 537-47, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25613986

RESUMO

BACKGROUND: Sensory stimulation is often provided to persons incurring severe traumatic brain injury (TBI), but therapeutic effects are unclear. OBJECTIVE: This preliminary study investigated neurobehavioral and neurophysiological effects related to sensory stimulation on global neurobehavioral functioning, arousal, and awareness. METHODS: A double-blind randomized placebo-controlled trial where 15 participants in states of disordered consciousness (DOC), an average of 70 days after TBI, were provided either the Familiar Auditory Sensory Training (FAST) or Placebo of silence. Global neurobehavioral functioning was measured with the Disorders of Consciousness Scale (DOCS). Arousal and awareness were measured with the Coma-Near-Coma (CNC) scale. Neurophysiological effect was measured using functional magnetic resonance imaging (fMRI). RESULTS: FAST (n = 8) and Placebo (n = 7) groups each showed neurobehavioral improvement. Mean DOCS change (FAST = 13.5, SD = 8.2; Placebo = 18.9, SD = 15.6) was not different, but FAST patients had significantly (P = .049; 95% confidence interval [CI] = -1.51, -.005) more CNC gains (FAST = 1.01, SD = 0.60; Placebo = 0.25, SD = 0.70). Mixed-effects models confirm CNC findings (P = .002). Treatment effect, based on CNC, is large (d = 1.88, 95% CI = 0.77, 3.00). Number needed to treat is 2. FAST patients had more fMRI activation in language regions and whole brain (P values <.05) resembling healthy controls' activation. CONCLUSIONS: For persons with DOC 29 to 170 days after TBI, FAST resulted in CNC gains and increased neural responsivity to vocal stimuli in language regions. Clinicians should consider providing the FAST to support patient engagement in neurorehabilitation.


Assuntos
Estimulação Acústica/métodos , Lesões Encefálicas/fisiopatologia , Lesões Encefálicas/reabilitação , Encéfalo/fisiopatologia , Reabilitação Neurológica/métodos , Doença Aguda , Adulto , Nível de Alerta/fisiologia , Percepção Auditiva/fisiologia , Conscientização/fisiologia , Método Duplo-Cego , Feminino , Humanos , Imagem por Ressonância Magnética , Masculino , Índice de Gravidade de Doença , Resultado do Tratamento
18.
Ann Neurol ; 77(4): 710-9, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25627340

RESUMO

OBJECTIVE: The Veterans Administration Cooperative Studies Program #468, a multicenter study that randomized Parkinson's disease (PD) patients to either subthalamic nucleus (STN) or globus pallidus internus (GPi) deep brain stimulation (DBS), found that stimulation at either target provided similar overall motoric benefits. We conducted an additional analysis of this data set to evaluate whether PD motor subtypes responded differently to the 2 stimulation targets. METHODS: We classified 235 subjects by motor subtype: tremor dominant (TD), intermediate (I), or postural instability gait difficulty (PIGD), based on pre-DBS baseline Unified Parkinson's Disease Rating Scale (UPDRS) scores off-medication. The primary outcome was change in UPDRS part III (UPDRS-III) off-medication scores from baseline to 24 months post-DBS, compared among subjects with particular PD motor subtypes and by DBS target (STN vs GPi). Changes in tremor, rigidity, akinesia, and gait scores were also assessed using the UPDRS. RESULTS: TD patients had greater mean overall motor improvement, measured by UPDRS-III, after GPi DBS, compared to STN DBS (17.5 ± 13.0 vs 14.6 ± 14.9, p = 0.02), with improvement in gait accounting for this difference. Regardless of stimulation target, PIGD subjects had lower mean overall improvement in UPDRS-III scores compared with I or TD subjects (8.7 ± 12.2 vs 21.7 ± 11.2 vs 16.3 ± 13.8, p = 0.001). INTERPRETATION: Our results suggest that responsiveness to both GPi and STN DBS is similar among different PD motor subtypes, although the TD motor subtype may have a greater response to GPi DBS with respect to gait. PIGD patients obtained less overall benefit from stimulation.


Assuntos
Estimulação Encefálica Profunda/métodos , Globo Pálido , Doença de Parkinson/classificação , Doença de Parkinson/terapia , Núcleo Subtalâmico , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença de Parkinson/diagnóstico , Método Simples-Cego , Resultado do Tratamento
19.
J Neurol Neurosurg Psychiatry ; 86(6): 622-9, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25185211

RESUMO

BACKGROUND: Deep brain stimulation (DBS) improves motor symptoms in Parkinson's disease (PD), but questions remain regarding neuropsychological decrements sometimes associated with this treatment, including rates of statistically and clinically meaningful change, and whether there are differences in outcome related to surgical target. METHODS: Neuropsychological functioning was assessed in patients with Parkinson's disease (PD) at baseline and after 6 months in a prospective, randomised, controlled study comparing best medical therapy (BMT, n=116) and bilateral deep brain stimulation (DBS, n=164) at either the subthalamic nucleus (STN, n=84) or globus pallidus interna (GPi, n=80), using standardised neuropsychological tests. Measures of functional outcomes were also administered. RESULTS: Comparison of the two DBS targets revealed few significant group differences. STN DBS was associated with greater mean reductions on some measures of processing speed, only one of which was statistically significant in comparison with stimulation of GPi. GPi DBS was associated with lower mean performance on one measure of learning and memory that requires mental control and cognitive flexibility. Compared to the group receiving BMT, the combined DBS group had significantly greater mean reductions at 6-month follow-up in performance on multiple measures of processing speed and working memory. After calculating thresholds for statistically reliable change from data obtained from the BMT group, the combined DBS group also displayed higher rates of decline in neuropsychological test performance. Among study completers, 18 (11%) study participants receiving DBS displayed reliable decline by multiple indicators in two or more cognitive domains, a significantly higher rate than in the BMT group (3%). This multi-domain cognitive decline was associated with less beneficial change in subjective ratings of everyday functioning and quality of life (QOL). The multi-domain cognitive decline group continued to function at a lower level at 24-month follow-up. CONCLUSIONS: In those with PD, the likelihood of significant decline in neuropsychological functioning increases with DBS, affecting a small minority of patients who also appear to respond less optimally to DBS by other indicators of QOL. TRIAL REGISTRATION NUMBER: NCT00056563 and NCT01076452.


Assuntos
Estimulação Encefálica Profunda/psicologia , Globo Pálido , Doença de Parkinson/psicologia , Doença de Parkinson/terapia , Núcleo Subtalâmico , Adulto , Idoso , Idoso de 80 Anos ou mais , Cognição/fisiologia , Progressão da Doença , Função Executiva , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Estudos Prospectivos , Desempenho Psicomotor , Qualidade de Vida , Resultado do Tratamento
20.
Stat Med ; 33(22): 3781-800, 2014 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-24820424

RESUMO

In this article, we develop appropriate statistical methods for determining the required sample size while comparing the efficacy of an intervention to a control with repeated binary response outcomes. Our proposed methodology incorporates the complexity of the hierarchical nature of underlying designs and provides solutions when varying attrition rates are present over time. We explore how the between-subject variability and attrition rates jointly influence the computation of sample size formula. Our procedure also shows how efficient estimation methods play a crucial role in power analysis. A practical guideline is provided when information regarding individual variance component is unavailable. The validity of our methods is established by extensive simulation studies. Results are illustrated with the help of two randomized clinical trials in the areas of contraception and insomnia.


Assuntos
Estudos Longitudinais , Modelos Estatísticos , Projetos de Pesquisa , Tamanho da Amostra , Humanos
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