Objective: To assess relationships between spinal cord MRI (SC-MRI) and retinal measures, and to evaluate whether these measures independently relate to clinical disability in multiple sclerosis (MS). Methods: One hundred two patients with MS and 11 healthy controls underwent 3-tesla brain and cervical SC-MRI, which included standard T1- and T2-based sequences and diffusion-tensor and magnetization-transfer imaging, and optical coherence tomography with automated segmentation. Clinical assessments included visual acuity (VA), Expanded Disability Status Scale, MS functional composite, vibration sensation threshold, and hip-flexion strength. Regions of interest circumscribing SC cross-sections at C3-4 were used to obtain cross-sectional area (CSA), fractional anisotropy (FA), perpendicular diffusivity (λ⊥), and magnetization transfer ratio. Multivariable regression assessed group differences and SC, retinal, and clinical relationships. Results: In MS, there were correlations between SC-CSA, SC-FA, SC-λ⊥, and peripapillary retinal nerve fiber layer (pRNFL) (p = 0.01, p = 0.002, p = 0.001, respectively) after adjusting for age, sex, prior optic neuritis, and brain atrophy. In multivariable clinical models, when SC-CSA, pRNFL, and brain atrophy were included simultaneously, SC-CSA and pRNFL retained independent relationships with low-contrast VA (p = 0.04, p = 0.002, respectively), high-contrast VA (p = 0.06, p = 0.008), and vibration sensation threshold (p = 0.01, p = 0.05). SC-CSA alone retained independent relationships with Expanded Disability Status Scale (p = 0.001), hip-flexion strength (p = 0.001), and MS functional composite (p = 0.004). Conclusions: In this cross-sectional study of patients with MS, correlations exist between SC-MRI and retinal layers, and both exhibit independent relationships with clinical dysfunction. These findings suggest that the SC and optic nerve reflect ongoing global pathologic processes that supplement measures of whole-brain atrophy, highlighting the importance of combining measures from unique compartments to facilitate a thorough examination of regional and global disease processes that contribute to clinical disability in MS.

We measured the relationship between the occurrence of photopsias (spontaneous phosphenes), and retinitis pigmentosa (RP) subjects’ level of vision, light exposure, and psychosocial factors to attempt to confirm RP patients’ previous reports of these associations. A total of 36 RP subjects self-administered PC-based binocular visual acuity, contrast sensitivity, and visual field tests at home twice a week, for 16 sessions in 2–3 months. After each session, subjects reported photopsias during the vision tests and completed questionnaires: Epworth Sleepiness Scale, Stanford Sleepiness Scale, Perceived Stress Scale, and Positive and Negative Affect Schedules. Across all subjects, photopsias occurred during 47% of sessions. Five (14%) subjects never noted photopsias, while five others noted photopsias at every session. Two-thirds of subjects experienced photopsias frequently (>20% of sessions). On average, the odds of noticing photopsias increased by 57% for every 1-point increase in mean perceived stress (OR=1.57; 95% CI: 1.04, 2.4; P=0.03) or reduced by 38% for every 1-point increase in positive mood (OR=0.62; 95% CI: 0.39, 0.98; P=0.04), after adjusting for age, gender, and vision. Similarly, the odds of experiencing photopsias during a session increased by 16% for every 3-point increase in perceived stress and decreased by 17% for every 3-point increase in positive mood, after adjusting for age and gender (OR=1.16; 95% CI: 1.01, 1.33; P=0.048)(OR=0.83; 95% CI: 0.73, 0.94; P=0.004), respectively. Frequency of photopsias was not statistically significantly related to other factors measured. Increased photopsias appear to be related to times when subjects report increased perceived stress and/or decreased positive mood, rather than RP patients’ age, level of vision, reported light exposure, or sleepiness.

Survey questionnaires and focus group discussions were used to investigate the association between a female participant's acceptance and her perception of her male partner's acceptance of an intravaginal gel as a prototype microbicide. Women who perceived their male partners would accept using the gel were more likely to highly accept the gel as compared to women who perceived their male partners would not accept using the gel (OR=24.57; 95%CI: 16.49-36.61). Qualitative analysis supported a positive association between female acceptability and perceived male partner acceptability. Qualitative research reiterated this finding and also found that men and women had different approaches to assess gel acceptability. Women integrated perceptions of their partner's acceptance into their own acceptability and reported their partners had positive experiences. In contrast, men reported a more neutral experience with the gel and assessed the gel without overt consideration of their partner's experiences. These results indicate that female perceptions of male partner acceptability and actual male partner acceptability need to be considered when addressing female-controlled product acceptability and use.

Purpose: The UNOS/OPTN Lung Allocation Score (LAS) has dramatically changed organ allocation in lung transplantation (LT). The impact of this change on patient outcomes is unknown. The purpose of the study was to examine mortality within one year after LT under this new system.

BACKGROUND:Cystic fibrosis (CF) patients have enhanced renal clearance of aminoglycosides and several beta-lactams and require higher dosages. Levofloxacin is a fluoroquinolone with extensive renal elimination and enhanced penetration into lungs and Pseudomonas aeruginosa (PA) biofilms. We studied the preliminary pharmacokinetic and pharmacodynamic (PK/PD) relationship of levofloxacin in CF. METHODS:Twelve patients at least 18 years old with a mild-to-moderate pulmonary exacerbation and fluoroquinolone-sensitive PA colonization received oral levofloxacin, 500 mg qd, for 14 days. Steady-state serum concentrations were collected after 3 to 7 days, and sputum samples for PA densities were collected before and after levofloxacin. PK/PD relationships for reducing PA sputum densities were evaluated. RESULTS:When compared to published data on non-CF patients, CF patients had similar area under the curve for 24 h (AUC(24)), total clearance, volume of distribution, maximum serum concentration (Cpmax), and elimination half-life: mean, 7.33 microg x h/mL/kg (SD, 1.70); 2.43 mL/min/kg (SD, 0.74); 1.33 L/kg (SD, 0.37); 7.06 microg/mL (SD, 2.35); and 6.44 h (SD, 1.1), respectively. Time to reach maximum serum concentration (Tmax) in CF was longer: mean, 2.20 h (SD, 0.99) vs 1.1 h (SD, 0.4) [p < 0.01]. Preliminary PK/PD analysis failed to demonstrate trends for decreasing PA sputum densities with increasing Cpmax/minimum inhibitory concentration (MIC) ratio and AUC(24)/MIC ratio. CONCLUSION:CF levofloxacin pharmacokinetics corrected for body weight are similar to non-CF, except for Tmax. Standard levofloxacin dosing (especially monotherapy) is unlikely to produce maximum therapeutic effectiveness. Additional levofloxacin studies in CF are necessary to evaluate its sputum concentrations; the benefits of higher daily dosages (>/= 750 mg); and establish PK/PD targets for managing PA pulmonary infections.

BACKGROUND:Few tools exist to quantify the performance of a hospital's information system from a user perspective. OBJECTIVES:Our objective was to develop and evaluate a survey-based metric that assesses the automation and usability of a hospital's information system. RESEARCH DESIGN AND METHODS:This is a cross-sectional study of 117 physicians and 3 chief information officers (CIOs) working in 2 community hospitals with historically low investment in IT (Hospitals A and B), an academic hospital with an advanced IT system (Hospital C), or a major Veterans Affairs hospital (Hospital D). Respondents completed a survey assessing their institution's information system. The mean of 90 summed responses yields the clinical information technology (CIT) index, a global measure of a hospital's information system performance on a 100-point scale. RESULTS:On the global CIT index, mean physician scores were significantly higher for hospitals with advanced IT (61.1 and 64.3 for C and D) compared with those with low investment in IT (32.6 and 29.4 for A and B, P < 0.001). These differences also were observed for each of 7 separate subdomains. The CIO scores, 74.7, 78.0 for Hospitals C and D, and 44.5 for Hospitals A and B, paralleled the mean physician scores for these hospitals. All measures exhibited low variance for each hospital (eg, standard deviations for the CIT index ranged from 5.9 to 8.1) and intraclass correlation was high (Chronbach's alpha >.70). CONCLUSIONS:This assessment tool demonstrates initial evidence of validity and reliability.

Aim: To evaluate the incidence of and risk factors for ocular complications in multibacillary (MB) leprosy patients during their 2 year, fixed duration, multidrug therapy (MDT). Methods: Periodic eye examinations were conducted prospectively on a cohort of 301 consecutive newly diagnosed MB patients every 6 months during their 2 year course of MDT. Incidence of ocular pathology was calculated as the number of events per person year of event free follow up of patients who did not have the specific finding at baseline. Results: 292 (97%) patients had one or more follow up visits. The incidence of lagophthalmos was 1.2%/patient year (95% CI 0.5% to 2.8%); corneal opacity was 7.4%/patient year (95% CI 5.1% to 10.6%); uveal involvement was 5.1%/patient year (95% CI 3.3% to 7.8%), and cataract that reduced vision to 6/18 or less was seen in 4.3%/patient year (95% CI 2.7% to 6.9%) of patients. Overall, 23 individuals (5.8%/patient year, 95% CI 3.9 to 8.8) developed leprosy related potentially blinding pathology during the 2 years of MDT. Conclusions: Approximately 20% of patients with MB leprosy can be expected to develop ocular complications of leprosy during a 2 year course of MDT, many (11%) of which are potentially vision threatening. Ophthalmological monitoring to detect and treat ocular complications at defined intervals during MDT is indicated.

PURPOSE: To assess the short-term safety and efficacy of treating subfoveal choroidal neovascularization (CNV) with external beam radiation delivered in 5 x 4 Gy fractions among patients having age-related macular degeneration (AMD).DESIGN: A multicenter prospective randomized controlled pilot study.METHODS: Eighty-eight patients were enrolled through 10 sites and were randomized to radiotherapy (20 Gy delivered in 5 daily fractions of 4 Gy each; 6 MV [N = 411) or no radiotherapy (sham radiotherapy EN = 22] or observation [N = 25]). Eligibility criteria included visual acuity of at least 20/320 and subfoveal CNV not ame- nable to treatment. Randomization was stratified by lesion type (new or recurrent CNV) and blood (<50% or greater than or equal to50% of the lesion [N = 13]). The primary outcome measure was loss of greater than or equal to3 lines of visual acuity. Secondary outcome measures were angiographic response and side effects.RESULTS: At baseline, patient and ocular characteristics were similar between treatment groups. At six months, 9 radiated eyes (26%) and 17 eyes not radiated (49%) lost greater than or equal to3 lines of visual acuity (P =.04; stratified X 2 test). At 12 months, 13 radiated eyes (42%) and 9 observed eyes (49%) lost greater than or equal to3 visual acuity lines (P =.60). The radiated group demonstrated smaller lesions and less fibrosis than the nonradiated group (P =.05 and .004, respectively) at 12 months. Radiation,induced complications were not observed except for one radiated eye with numerous cotton wool spots and possible radiation retinopathy.CONCLUSIONS: External beam radiation at 5 x 4 Gy may have a modest and short,lived (six month) benefit in preserving visual acuity. (C) 2004 by Elsevier Inc. All rights reserved.

Symptoms are important indicators of health and treatment for people with HIV. Symptoms are measured by patient self-report, but there has been little attention to what is the best method of elicitation. We compared three methods ( presence, frequency, and bother) commonly used to measure HIV self-reported symptoms. CD4 + T lymphocyte count and health-related quality of life (HRQL) scales were used to test validity in 160 people with HIV. The average number of symptoms reported was 15.2 (standard deviation 8.4). Correlation coefficients of summary symptom scores using the three methods ranged from -0.30 to -0.36 with HRQL score and from -0.19 to -0.20 with CD4 + count (p < 0.05). Correlation coefficients of seven specific symptom items with CD4 counts and HRQL scores for the same concepts were small to moderate (-0.08 to -0.58, p < 0.05). For the three methods, the correlation coefficients in general tended to be greater with frequency or bother than presence. However, the differences among the three methods were not statistically significant. We conclude that no single method is superior to the others.

PURPOSETo describe the predictive value of liver function tests (LFTs), chest x-ray, and diagnostic imaging for detecting melanoma metastasis during routine follow-up after treatment for choroidal melanoma.MATERIALS AND METHODSProspective longitudinal follow-up of patients enrolled onto two randomized trials was conducted by the Collaborative Ocular Melanoma Study (COMS) Group. Baseline and annual or semiannual systemic and laboratory evaluations were performed according to a standard protocol for 2320 patients enrolled on the COMS.RESULTSCOMS patients were screened annually for metastasis and new cancers using LFTs (alkaline phosphatase, AST, ALT, or bilirubin). Elevated findings (1.5 to 2 times upper limit of normal) on LFT prompted a diagnostic or imaging test to confirm or rule out cancer recurrence. Of 714 patients with clinical reports of metastasis, 675 patients died. Of these 675 patients, all but four had either histopathologically confirmed or clinically suspected metastatic melanoma present at the time of death. Among all patients, the 5-year cumulative diagnosis rate of metastatic melanoma was 24% (95% CI, 22% to 27%). Based on all patients with reported metastasis, the sensitivity, specificity, positive predictive value and negative predictive value associated with at least one abnormal LFT before first diagnosis of metastasis at any site was 14.7%, 92.3%, 45.7% and 71.0%, respectively.CONCLUSIONUse of LFTs results followed by diagnostic tests has high specificity and predictive values but low sensitivity. Better tests are needed to identify earlier metastatic disease associated with choroidal melanoma.