Visual fields at follow-up in the Ischemic Optic Neuropathy Decompression Trial: evaluation of change in pattern defect and severity over time.

PURPOSE: To evaluate change from baseline to 12 months follow-up in study and nonstudy (fellow) eye visual fields from the Ischemic Optic Neuropathy Decompression Trial (IONDT). DESIGN: Randomized controlled trial and observational study. PARTICIPANTS: The IONDT enrolled patients >or=50 years with acute nonarteritic ischemic optic neuropathy (NAION). Randomized patients (n = 258) had visual acuity 20/64 or refused randomization. INTERVENTIONS: Optic nerve decompression surgery (n = 127) or careful follow-up (n = 131). MAIN OUTCOME MEASURES: We measured visual fields at baseline and at 6 and 12 months follow-up. Using a computerized system, we classified visual field defects by pattern, location, and severity. We examined changes over time by treatment group, age, baseline comorbidities, and change in visual acuity. In fellow (nonstudy) eyes, we assessed change by whether NAION was present at baseline and also incidence of NAION by whether a visual field defect was present at baseline. RESULTS: We analyzed 245 study eye visual field pairs (179 and 66, randomized and nonrandomized, respectively) for change from baseline to 12 months. We observed significant changes in defect distribution within the central field (P = 0.02) for randomized eyes. Superior and inferior altitudinal defects were less severe at follow-up in both randomized and nonrandomized eyes. We observed an association between change in central field severity and change in visual acuity from baseline (P<0.001 at 6 months; P = 0.01 at 12 months; Kendall's tau-b), but no association between visual field change and treatment group, age, or baseline comorbidities. Superior and inferior visual field defects present at baseline in nonstudy eyes improved at follow-up. Fellow (nonstudy) eyes with normal fields did not have an increased risk of developing NAION compared with eyes with >or=1 defects. CONCLUSIONS: Visual fields of NAION patients enrolled in the IONDT were relatively stable from baseline to follow-up. A visual field defect in the nonstudy eye at baseline was not associated with development of NAION during follow-up compared with eyes with normal fields.

Development and validation of a computerized expert system for evaluation of automated visual fields from the Ischemic Optic Neuropathy Decompression Trial.

BACKGROUND: The objective of this report is to describe the methods used to develop and validate a computerized system to analyze Humphrey visual fields obtained from patients with non-arteritic anterior ischemic optic neuropathy (NAION) and enrolled in the Ischemic Optic Neuropathy Decompression Trial (IONDT). The IONDT was a multicenter study that included randomized and non-randomized patients with newly diagnosed NAION in the study eye. At baseline, randomized eyes had visual acuity of 20/64 or worse and non-randomized eyes had visual acuity of better than 20/64 or were associated with patients refusing randomization. Visual fields were measured before treatment using the Humphrey Field Analyzer with the 24-2 program, foveal threshold, and size III stimulus. METHODS: We used visual fields from 189 non-IONDT eyes with NAION to develop the computerized classification system. Six neuro-ophthalmologists ("expert panel") described definitions for visual field patterns defects using 19 visual fields representing a range of pattern defect types. The expert panel then used 120 visual fields, classified using these definitions, to refine the rules, generating revised definitions for 13 visual field pattern defects and 3 levels of severity. These definitions were incorporated into a rule-based computerized classification system run on Excel(R) software. The computerized classification system was used to categorize visual field defects for an additional 95 NAION visual fields, and the expert panel was asked to independently classify the new fields and subsequently whether they agreed with the computer classification. To account for test variability over time, we derived an adjustment factor from the pooled short term fluctuation. We examined change in defects with and without adjustment in visual fields of study participants who demonstrated a visual acuity decrease within 30 days of NAION onset (progressive NAION). RESULTS: Despite an agreed upon set of rules, there was not good agreement among the expert panel when their independent visual classifications were compared. A majority did concur with the computer classification for 91 of 95 visual fields. Remaining classification discrepancies could not be resolved without modifying existing definitions. Without using the adjustment factor, visual fields of 63.6% (14/22) patients with progressive NAION and no central defect, and all (7/7) patients with a paracentral defect, worsened within 30 days of NAION onset. After applying the adjustment factor, the visual fields of the same patients with no initial central defect and 5/7 of the patients with a paracentral defect were seen to worsen. CONCLUSION: The IONDT developed a rule-based computerized system that consistently defines pattern and severity of visual fields of NAION patients for use in a research setting.

Neurophysiologic assessment of neonatal sleep organization: preliminary results of a randomized, controlled trial of skin contact with preterm infants.

BACKGROUND: Sleep is important to brain organization, but few strategies to promote sleep among premature infants have been tested. Behaviorally based measures of sleep have shown increased quiet sleep (QS) and decreased active sleep (AS) during skin-to-skin contact (SSC) with the mother, but these results have not been confirmed with objective electroencephalographic/polysomnographic measures of sleep organization. Important differences exist between behavioral and electroencephalographic/polysomnographic definitions of sleep state. METHODS: Data for the first 28 relatively healthy, preterm subjects of an ongoing randomized trial of one 2- to 3-hour session of SSC or incubator care between feedings are reported here. Infants were positioned prone, inclined, and nested in an incubator during the 2- to 3-hour pretest period, were fed, and then went into the test period of SSC or incubator care. Infants were left largely undisturbed throughout testing. A mixed-model regression analysis compared the test-pretest differences in outcome measures within and between groups. RESULTS: Results showed that arousals were significantly lower in the SSC group, compared with the control group, for the entire study period and for test-pretest matched segments of QS and AS. Rapid eye movement was significantly lower for the SSC group for the study period and AS segments. Indeterminate sleep was significantly lower for the SSC group when confounding environmental variables were included in the regression analysis. When 4 subjects who experienced excessive ambient light levels during SSC were removed from analysis, QS increased during SSC. CONCLUSIONS: The patterns demonstrated by the SSC group are analogous to more-mature sleep organization. SSC may be used as an intervention to improve sleep organization in this population of preterm infants.

Biological monitoring and surveillance results of Gulf War I veterans exposed to depleted uranium.

OBJECTIVE: To relate medical surveillance outcomes to uranium biomonitoring results in a group of depleted uranium (DU)-exposed, Gulf War I veterans. METHODS: Thirty-two veterans of Gulf War I who were victims of 'friendly fire' involving DU weapons, in whom exposure assessment can accurately be measured, had urine uranium concentrations determined using ICP-MS technology. Clinical laboratory parameters were measured and related to urine uranium concentrations. Data were examined by stratifying the cohort into a low U group, <0.10 mug/g creatinine versus a high U group, >/=0.10 mug/g creatinine and assessing differences between groups. RESULTS: Over a decade after first exposure, soldiers possessing embedded DU fragments continue to excrete elevated concentrations of uranium in urine. No clinically significant uranium related health effects were observed in blood count, blood chemistries including renal markers, neuropsychological measures, and semen quality or genotoxicity measures. Markers of early changes in renal glomerular and tubular function were not statistically different between groups; however, genotoxicity measures continue to show subtle, mixed results. CONCLUSION: Persistent urine uranium elevations continue to be observed more than 12 years since first exposure. Despite this, renal and other clinical abnormalities were not observed, likely due to the 'relatively' low uranium burden in this cohort compared to historical uranium-exposed occupational groups. Continuing surveillance is indicated, however, due to the on-going nature of the exposure. These results are an important finding in light of the on-going controversy regarding health effects observed in soldiers of the Gulf War and other conflicts, whose uranium exposure assessment is unable to be accurately determined.

Racial differences in rate of decline in bone mass in older men: the Baltimore men's osteoporosis study.

UNLABELLED: Older black men have higher adjusted BMD than older white men. Using data from a longitudinal cohort study of older men followed for a mean of 18.8 +/- 6.5 (SD) months, we found that older black men have a higher rate of decline in femoral neck and total hip BMD and femoral neck BMAD than older white men. INTRODUCTION: Older black men have higher adjusted BMD compared with older white men. The difference in BMD may be caused by having attained higher peak bone mass as young adults and/or having a slower rate of decline in bone mass as adults. There are few published longitudinal data on change in bone mass in older white men and no published data for older black men. MATERIALS AND METHODS: Three hundred forty-nine white men and 119 black men 65 of age (mean age, 75 +/- 5.7 and 72 +/- 5.6 years, respectively) who participated in the longitudinal component of the Baltimore Men's Osteoporosis Study returned for a second visit after a mean of 18.8 +/- 6.5 (SD) months and were not taking medications used to treat low bone mass at either visit. BMD was measured at the femoral neck and total hip by Hologic-certified technicians using a QDR 2000 at the baseline visit (V1) and QDR 4500 at the first follow-up visit (V2). Participants also completed self-administered and interviewer-administered questionnaires and underwent standardized clinic examinations. Bone mineral apparent density (BMAD) at the femoral neck was calculated as an estimate of volumetric BMD. Annual crude and multiple variable adjusted percent changes in BMD and BMAD were calculated. RESULTS: In univariate analyses, black men had lower percent decline in femoral neck and total hip BMD and femoral neck BMAD than white men. In addition, older age at baseline, lower baseline weight, current smoking, and lower baseline BMD were associated with greater percent decline per year in femoral neck BMD; older age at baseline, current smoking, and lower baseline BMD were associated with greater percent decline per year in total hip BMD; and older age at baseline and lower baseline femoral neck BMAD were associated with greater percent decline per year in femoral neck BMAD. Racial differences in bone loss persisted in multiple variable models that controlled for other factors associated with change in BMD and BMAD. CONCLUSIONS: Older black men seem to lose bone mass at a slower rate than older white men. These differences in the rate of bone loss may account, in part, for the racial disparities in BMD and BMAD and risk of osteoporotic fractures among older men.

Robotic upper-limb neurorehabilitation in chronic stroke patients.

This pilot study tested the effectiveness of an intense, short-term upper-limb robotic therapy for improvement in motor outcomes among chronic stroke patients. We enrolled 30 subjects with upper-limb deficits due to stroke of at least 6 mo duration and with a Motor Power Assessment grade of 3 or less. Over 3 wk, 18 sessions of robot-assisted task-specific therapy were delivered with the use of a robotic exercise device that simulates a conventional therapy known as skateboard therapy. Primary outcome measures included reliable, validated impairment and disability measures of upper-limb motor function. Statistically significant improvements were observed for severely impaired participants when we compared baseline and posttreatment outcomes (p < 0.05). These results are important because they indicate that improvement is not limited to those with moderate impairments but is possible among severely impaired chronic stroke patients as well. Moderately and severely impaired patients in our study were able to tolerate a massed-practice therapy paradigm with intensive, frequent, and repetitive treatment. This information is useful in determining the optimal target population, intensity, and duration of robotic therapy and sample size for a planned larger trial.

Inflammatory markers in intrauterine and fetal blood and cerebrospinal fluid compartments are associated with adverse pulmonary and neurologic outcomes in preterm infants.

Recent evidence strongly implicates the inflammatory response to intrauterine infection in the pathogenesis of neonatal brain and lung injury. We hypothesized that lung and brain injury in preterm infants occurs during a common developmental window of vulnerability as the result of an inflammatory response in different compartments. To determine whether inflammatory markers in these compartments are associated with bronchopulmonary dysplasia (BPD) or cranial ultrasound (CUS) abnormalities in infants <33 wk gestation age (GA) and <1501 g birth weight, we analyzed placental pathology and serum and cerebrospinal fluid (CSF) IL-6, IL-1beta, and tumor necrosis factor-alpha (TNF-alpha) concentrations in 276 infants. Logistic regressions were performed stratified by GA. Histologic chorioamnionitis was significantly associated with BPD in infants /=17 pg/mL was associated with an abnormal CUS in infants >28 wk GA (OR 3.36, p = 0.023) but not /=6.5 pg/mL and TNF-alpha >/=3 pg/mL were associated with abnormal CUS in infants /=28 wk GA. These data suggest that in infants

Health effects of depleted uranium on exposed Gulf War veterans: a 10-year follow-up.

Medical surveillance of a group of U.S. Gulf War veterans who were victims of depleted uranium (DU) "friendly fire" has been carried out since the early 1990s. Findings to date reveal a persistent elevation of urine uranium, more than 10 yr after exposure, in those veterans with retained shrapnel fragments. The excretion is presumably from ongoing mobilization of DU from fragments oxidizing in situ. Other clinical outcomes related to urine uranium measures have revealed few abnormalities. Renal function is normal despite the kidney's expected involvement as the "critical" target organ of uranium toxicity. Subtle perturbations in some proximal tubular parameters may suggest early although not clinically significant effects of uranium exposure. A mixed picture of genotoxic outcomes is also observed, including an association of hypoxanthine-guanine phosphoribosyl transferase (HPRT) mutation frequency with high urine uranium levels. Findings observed in this chronically exposed cohort offer guidance for predicting future health effects in other potentially exposed populations and provide helpful data for hazard communication for future deployed personnel.

Racial differences in bone mineral density in older men.

UNLABELLED: Studies have examined factors related to BMD in older white, but not black, men. We measured BMD in older white and black men and examined factors related to racial differences in BMD. Black men had significantly higher adjusted BMD at all sites. These results may explain, in part, the lower incidence of fractures in older black men. INTRODUCTION: Several studies have examined factors associated with bone mineral density (BMD)in older men. None, however, have had sufficient numbers of black men to allow for meaningful comparisons by race. MATERIALS AND METHODS: A total of 503 white and 191 black men aged 65 and older(75.1 +/- 5.8 and 72.2 +/- 5.7 years, respectively) were recruited from the Baltimore metropolitan area. All men completed a battery of self-administered questionnaires, underwent a standardized examination, and had BMD measured at the femoral neck, lumbar spine, and total body. Data were analyzed using multiple variable linear regression models, adjusted for potential confounding variables; two-way interactions with main effects were included in models where appropriate. RESULTS: Black men had significantly higher adjusted BMD at the femoral neck (difference 0.09 [95% CI: 0.07, 0.12] mg/cm2), lumbar spine (0.07 [0.04, 0.10] mg/cm2), and total body (0.06 [0.03, 0.08] mg/cm2) than white men. CONCLUSIONS: Older black men have significantly higher BMD than older white men, even after adjustment for factors associated with BMD. These differences, especially at the femoral neck, may explain the reduced incidence of hip fracture in black compared with white men.

The effect of active surveillance for vancomycin-resistant enterococci in high-risk units on vancomycin-resistant enterococci incidence hospital-wide.

BACKGROUND: Vancomycin-resistant enterococci (VRE) have become a major cause of nosocomial infections and are now endemic in many geographic areas. The aim of this study was to describe the effect of active surveillance for patients with VRE in high-risk units on the VRE incidence rate hospital-wide. METHODS: We determined 4 time periods based on the intervention of active surveillance: preactive surveillance (period 1), active surveillance (period 2), no active surveillance (period 3), and reinstutition of active surveillance (period 4). VRE incidence rates based on first clinical culture for VRE per 10,000 patient days for each of these periods and incidence rate ratios were then calculated. RESULTS: Active surveillance in high-risk units was associated with a significant reduction in VRE incidence hospital-wide in 2 of the 3 comparisons made. The incidence rate ratio when comparing the first period of active surveillance (period 2) to the preactive surveillance period (period 1) was 0.63 (95% CI, 0.38-1.1); it was 0.36 (95% CI, 0.23-0.55) when comparing the first period of active surveillance (period 2) to the subsequent period (period 3) and 0.68 (95% CI, 0.54-0.85) when comparing the second period of active surveillance (period 4) to the prior period without active surveillance periods. CONCLUSIONS: Active surveillance culturing for VRE in the high risk-units prevented further VRE transmission, as evidenced by a significant increase in hospital-wide incidence rates when active surveillance was discontinued and a significant decrease in incidence rates when it was restarted.