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1.  Measuring Refraction in Adults in Epidemiological Studies 
Archives of ophthalmology  2010;128(1):88-92.
To compare refraction measured pre- and post- pharmacologic cycloplegia.
This study used preliminary data from the Beaver Dam Offspring Study, which includes adult children of participants in the population-based Epidemiology of Hearing Loss Study of older adults living in Beaver Dam, Wisconsin. Data were available for 5018 eyes of 2529 participants. Refraction was defined by the spherical equivalent (SE), using autorefractor readings. Differences were calculated as the SE after drops minus the SE before drops. Myopia was defined as SE ≤ -1 diopter (D), emmetropia as -1 D< SE< 1 D, and hyperopia as SE ≥ 1 D.
The mean age was 48 years (range 22 to 84). The mean difference in SE between pre- and post- cycloplegia was 0.29 D (95% confidence interval 0.28, 0.31). The difference decreased with age, and varied by refractive status for participants younger than 50 years of age, with largest differences observed among young persons with hyperopic refractive errors. Across all age groups, agreement on classifications of refraction was high (84% to 92%).
Overall, clinically inconsequential differences were observed between SEs before and after pharmacologic cycloplegia suggesting that cycloplegia may not be necessary in epidemiological studies of refraction in adults.
PMCID: PMC2808196  PMID: 20065223
2.  Test–Retest Reliability of the San Diego Odor Identification Test and Comparison with the Brief Smell Identification Test 
Chemical Senses  2009;34(5):435-440.
This study described the San Diego Odor Identification Test (SDOIT) reliability and compared the SDOIT and the Brief Smell Identification Test (B-SIT). Ninety participants aged 50–70 years completed this 2-visit olfaction study. During visit 1, the SDOIT and B-SIT were administered according to standard protocols. Three weeks later, participants returned to retake the SDOIT. The SDOIT score was the total number of odorants correctly identified out of 8 odorants presented, and olfactory impairment was defined as correctly identifying less than 6 odorants. The B-SIT score was the total number of odorants correctly identified out of 12 odorants presented, and participants correctly identifying less than 9 odorants were categorized as abnormal. The SDOIT reliability was high (concordance correlation coefficient = 0.85, 95% confidence interval [CI] = 0.79–0.91). The same score was obtained on retest for 73% of participants, whereas 18% improved, and 9% declined. Test–retest agreement was 96% for the SDOIT; 4% improved from impaired at visit 1 to unimpaired at visit 2. Overall, SDOIT impairment classification and B-SIT abnormal classification agreed in 96% of participants (κ = 0.81, 95% CI = 0.63–0.99). In conclusion, the SDOIT showed good test–retest reliability. Agreement for impaired/abnormal olfaction was demonstrated for the SDOIT and the B-SIT.
PMCID: PMC2682444  PMID: 19363087
epidemiology; impairment; methods; olfaction
3.  Elevated CD8 Counts During HAART are Associated with HIV Virologic Treatment Failure 
To evaluate whether elevated CD8 counts are associated with increased risk of virologic treatment failure in HIV-infected individuals.
Retrospective cohort study.
U.S. Military HIV Natural History Study participants who initiated HAART in 1996-2008, had 6- and 12-month post-HAART HIV RNA <400 c/ml, ≥2 subsequent HIV viral loads and a baseline CD8 count were eligible (n=817). Baseline was 12 months after HAART start, virologic failure was defined as confirmed HIV RNA ≥400 c/ml, and CD8 counts ≥1200 cells/mm3 were considered elevated. Cox models were used to examine the effect of baseline and time-updated CD8 counts on virologic failure.
There were 216 failures for a rate of 5.6 per 100 person-years (95% confidence interval [CI] 4.9-6.4). Among those initiating HAART in 2000-2008, participants with elevated baseline CD8 counts had significantly greater risk of virologic failure compared to those with baseline CD8 counts ≤600 cells/mm3 (hazard ratio [HR] = 2.68, 95% CI 1.13 – 6.35). Participants with elevated CD8 counts at >20% of prior 6-month follow-up visits had greater risk of failure at the current visit than those who did not (HR = 1.53, 95% CI 1.14 - 2.06). Those with CD8 counts that increased after HAART start had greater risk of failure than those with CD8 counts that decreased or remained the same (HR = 1.59, 95% CI 1.19 – 2.13).
Initial or serial elevated CD8 counts while on HAART or an increase in CD8 counts from HAART initiation may be early warnings for future treatment failure.
PMCID: PMC3173352  PMID: 21602694
Human immunodeficiency virus; CD8 count; antiretroviral therapy; HIV viral load suppression; HIV virologic failure
4.  Socioeconomic Status and Subclinical Atherosclerosis in Older Adults 
Preventive medicine  2010;52(3-4):208-212.
This study investigated the long-term effects of socioeconomic status (SES) on atherosclerosis.
Data from the Epidemiology of Hearing Loss Study and the Beaver Dam Eye Study (Beaver Dam, WI, 1998-2000), were used to examine adult SES (education, household income, longest-held job) and childhood SES (household density and parental home ownership at age 13) associations with carotid intima-media thickness (IMT) and carotid plaque in a cohort of 2,042 men and women aged 53 to 94 years.
For education, income, and occupation (women), those in the lowest SES group had statistically larger age-sex-adjusted IMT than those in the highest SES group (<12 vs. >12 years education: 0.92 vs. 0.86 mm respectively, P<0.0001), (<$10,000 vs. >$45,000: 0.97 vs. 0.87 mm, P<0.0001), (operator/fabricator/labor vs. manager/professional: 0.89 vs. 0.82 mm, P<0.001). Associations were similar using carotid plaque as the outcome. Participants with low levels of both adult and childhood SES measures had age-sex-adjusted IMT greater than those with persistently high levels of SES (0.93 vs. 0.84 mm, P<0.0001).
Measures of SES at two points in the life-span were associated with subclinical atherosclerosis.
PMCID: PMC3062713  PMID: 21195728
Socioeconomic Status; Intima-media Thickness; Atherosclerosis; Carotid Artery plaque; Cardiovascular disease; Life-course epidemiology
5.  Clinical, demographic and laboratory parameters at HAART initiation associated with decreased post-HAART survival in a U.S. military prospective HIV cohort 
Although highly active antiretroviral therapy (HAART) has improved HIV survival, some patients receiving therapy are still dying. This analysis was conducted to identify factors associated with increased risk of post-HAART mortality.
We evaluated baseline (prior to HAART initiation) clinical, demographic and laboratory factors (including CD4+ count and HIV RNA level) for associations with subsequent mortality in 1,600 patients who began HAART in a prospective observational cohort of HIV-infected U.S. military personnel.
Cumulative mortality was 5%, 10% and 18% at 4, 8 and 12 years post-HAART. Mortality was highest (6.23 deaths/100 person-years [PY]) in those with ≤ 50 CD4+ cells/mm3 before HAART initiation, and became progressively lower as CD4+ counts increased (0.70/100 PY with ≥ 500 CD4+ cells/mm3). In multivariate analysis, factors significantly (p < 0.05) associated with post-HAART mortality included: increasing age among those ≥ 40 years (Hazard ratio [HR] = 1.32 per 5 year increase), clinical AIDS events before HAART (HR = 1.93), ≤ 50 CD4+ cells/mm3 (vs. CD4+ ≥ 500, HR = 2.97), greater HIV RNA level (HR = 1.36 per one log10 increase), hepatitis C antibody or chronic hepatitis B (HR = 1.96), and HIV diagnosis before 1996 (HR = 2.44). Baseline CD4+ = 51-200 cells (HR = 1.74, p = 0.06), and hemoglobin < 12 gm/dL for women or < 13.5 for men (HR = 1.36, p = 0.07) were borderline significant.
Although treatment has improved HIV survival, defining those at greatest risk for death after HAART initiation, including demographic, clinical and laboratory correlates of poorer prognoses, can help identify a subset of patients for whom more intensive monitoring, counseling, and care interventions may improve clinical outcomes and post-HAART survival.
PMCID: PMC3320559  PMID: 22339893
Highly active antiretroviral therapy; mortality; CD4+ lymphocyte count
6.  The Prevalence of Age-Related Macular Degeneration and Associated Risk Factors: The Beaver Dam Offspring Study 
Archives of ophthalmology  2010;128(6):750-758.
To determine the prevalence of age-related macular degeneration (AMD) and examine relationships of retinal drusen, retinal pigmentary abnormalities and early AMD to age, sex and other risk factors in 2810 people 21-84 years of age, participating in the Beaver Dam Offspring Study (BOSS).
The presence and severity of various characteristics of drusen and other lesions typical of AMD were determined by grading digital color fundus images using the Wisconsin Age-Related Maculopathy Grading System.
Early AMD was present in 3.4% of the cohort and varied from 2.4% in those 21-34 years of age to 9.8% in those 65 years of age or older. In a multivariable model (expressed as Odds Ratio [OR]; 95% Confidence Interval [CI]), age (1.22 per 5 years of age; 1.09, 1.36), being male (1.65; 1.01, 2.69), more pack years smoked (1 to 10 vs 0, 1.31; 0.75, 2.29; 11+ vs 0, 1.67; 1.03, 2.73), higher serum HDL cholesterol (per 5 mg/dL 0.91; 0.83, 0.998), and hearing impairment (2.28; 1.41, 3.71) were associated with early AMD. There were no associations of blood pressure level, body mass index, physical activity, history of heavy drinking, white blood cell count, hematocrit, platelet count, serum total cholesterol, or carotid intimal-medial thickness with early AMD.
These data indicate that early AMD is infrequent before age 55 years but increases with age thereafter. Early AMD is related to modifiable risk factors, e.g., smoking and serum HDL cholesterol.
PMCID: PMC2896217  PMID: 20547953
age-related macular degeneration; prevalence; risk factors
7.  Long-term CD4+ lymphocyte response following HAART initiation in a U.S. Military prospective cohort 
Among HIV-infected persons initiating highly active antiretroviral therapy (HAART), early CD4+ lymphocyte count increases are well described. However, whether CD4+ levels continue to increase or plateau after 4-6 years is controversial.
To address this question and identify other determinants of CD4+ response, we analyzed data for 1,846 persons from a prospective HIV military cohort study who initiated HAART, who had post-HAART CD4+ measurements, and for whom HIV seroconversion (SC) date was estimated.
CD4+ count at HAART initiation was ≤ 200 cells/mm3 for 23%, 201-349 for 31%, 350-499 for 27%, and ≥500 for 19%. The first 6 months post-HAART, the greatest CD4+ increases (93-151 cells) occurred, with lesser increases (22-36 cells/year) through the first four years. Although CD4+ changes for the entire cohort were relatively flat thereafter, HIV viral load (VL) suppressors showed continued increases of 12-16 cells/year. In multivariate analysis adjusting for baseline CD4+ and post-HAART time interval, CD4+ responses were poorer in those with: longer time from HIV SC to HAART start, lower pre-HAART CD4+ nadir, higher pre-HAART VL, and clinical AIDS before HAART (P < 0.05).
Small but positive long-term increases in CD4+ count in virally suppressed patients were observed. CD4+ response to HAART is influenced by multiple factors including duration of preceding HIV infection, and optimized if treatment is started with virally suppressive therapy as early as possible.
PMCID: PMC3037838  PMID: 21244701
8.  Valganciclovir for Suppression of Human Herpesvirus 8 Replication: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial 
Human herpesvirus 8 (HHV-8) replication is critical in the induction and maintenance of Kaposi sarcoma, primary effusion lymphoma and some cases of Castleman disease. In vitro and observational studies suggest that ganciclovir inhibits HHV-8 replication, but no randomized clinical trials have been conducted.
26 HHV-8-infected men were randomized to receive 8 weeks of oral valganciclovir (900 mg once daily) or matching placebo. After a 2 week washout period, participants received the other study drug for 8 additional weeks. Oral swabs for HHV-8 and CMV DNA quantification by real-time PCR were collected daily during the study.
16 HIV-positive and 10 HIV-negative men enrolled and completed the study. 3029(88%) of 3439 anticipated swabs were available for analysis. HHV-8 was detected on 44% of days on placebo versus 23% on valganciclovir (relative risk [RR] 0.54, 95% confidence interval (CI) 0.33-0.90, p=0.02). Valganciclovir reduced CMV oral shedding by 80% (RR 0.20 95% CI 0.08-0.48, p<0.001). HHV-8 and CMV shedding were independent. Hematologic, renal or hepatic toxicities were no more common on active drug versus placebo, though valganciclovir recipients reported more days of diarrhea.
Once daily oral valganciclovir is well tolerated and significantly reduces HHV-8 replication.
PMCID: PMC2700177  PMID: 18491970
9.  Multiplex Real-Time Reverse Transcription-PCR Assay for Determination of Hepatitis C Virus Genotypes▿  
Journal of Clinical Microbiology  2006;44(11):4149-4156.
A variety of methods have been used to determine hepatitis C virus (HCV) genotypes. Because therapeutic decisions for chronic HCV-related hepatitis are made on the basis of genotype, it is important that genotype be accurately determined by clinical laboratories. Existing methods are often subjective, inaccurate, manual, time-consuming, and contamination prone. We therefore evaluated real-time reverse transcription-PCR (RT-PCR) reagents that have recently become commercially available (Abbott HCV Genotype ASR). The assay developed by our laboratory starts with purified RNA and can be performed in 4 to 5 h. An initial evaluation of 479 samples was done with a restriction fragment length polymorphism (RFLP) method and the RT-PCR assay, and discrepant samples were sequenced. An additional 1,200 samples were then tested, and data from all assays were used to evaluate the efficiency and specificity of each genotype-specific reaction. Good correlation between results by the two methods was seen. Discrepant samples included those indeterminate by the RT-PCR assay (n = 110) and a subset that were incorrectly called 2a by the RFLP method (n = 75). The real-time RT-PCR assay performed well with genotype 1, 2, and 3 samples. Inadequate numbers of samples were available to evaluate fully genotypes 4, 5, and 6. Analysis of each primer-probe set demonstrated that weak cross-reactive amplifications were common but usually did not interfere with the genotype determination. However, in about 1% of samples, two or more genotypes amplified at roughly equivalent amounts. Further studies are necessary to determine whether these mixed-genotype samples are true mixtures or a reflection of occasional cross-reactive amplifications.
PMCID: PMC1698294  PMID: 16988019

Results 1-9 (9)