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Objective. To assess how Institutional Review Boards (IRBs) implement the assent requirement for research with children. Methods. Telephone interviews were conducted with 188 chairpersons of IRBs from a range of institutions nationwide. Respondents were queried on 4 topics: 1) which children are considered capable of assent, 2) which information investigators must provide pediatric research subjects, 3) whether IRBs favor the enrollment of children who are capable of assent, and 4) how chairpersons view payment for children’s research participation. Results. Half of IRBs have a method that they require investigators to follow when determining which children are capable of assent, most commonly an age cutoff. Half of IRBs do not have a method, and the majority rely on investigators’ clinical judgment. IRBs largely follow the adult research regulations when determining which information should be provided to an assenting child. A total of 58% of IRBs would enroll a child who is incapable of assent in a nonbeneficial study, even if children who are capable of assent could be enrolled instead. Almost half (46%) of chairpersons believe that it sometimes or always acceptable to offer incentive payments to children, and more than one third (35%) thought it acceptable to offer payment to the parents. Conclusion. When possible, IRBs follow the federal regulations for research with adults when implementing the assent requirement. For considerations that do not have analogs in the adult regulations, IRB practices vary widely. These data suggest that IRBs need guidance on how to implement the assent requirement in a way that provides appropriate protections for pediatric research subjects.

To identify the ethical dilemmas that internists encounter, the strategies they use to address them, and the usefulness of ethics consultation.National telephone survey.Doctors' offices.General internists, oncologists, and critical care/pulmonologists (N = 344, 64% response rate).Types of ethical dilemmas recently encountered and likelihood of requesting ethics consultation; satisfaction with resolution of ethical dilemmas with and without ethics consultation.Internists most commonly reported dilemmas regarding end-of-life decision making, patient autonomy, justice, and conflict resolution. General internists, oncologists, and critical care specialists reported participating in an average of 1.4, 1.3, and 4.1 consultations in the preceding 2 years, respectively (P.0001). Physicians with the least ethics training had the least access to and participated in the fewest ethics consultations; 19% reported consultation was unavailable at their predominant practice site. Dilemmas about end-of-life decisions and patient autonomy were often referred for consultation, while dilemmas about justice, such as lack of insurance or limited resources, were rarely referred. While most physicians thought consultations yielded information that would be useful in dealing with future ethical dilemmas (72%), some hesitated to seek ethics consultation because they believed it was too time consuming (29%), might make the situation worse (15%), or that consultants were unqualified (11%).While most internists recall recent ethical dilemmas in their practices, those with the least preparation and experience have the least access to ethics consultation. Health care organizations should emphasize ethics educational activities to prepare physicians for handling ethical dilemmas on their own and should improve the accessibility and responsiveness of ethics consultation when needed.

ContextC-reactive protein (CRP) is a systemic inflammatory marker associated with risk for cardiovascular disease (CVD). Some risk factors for CVD are associated with age-related macular degeneration (AMD), but the association between CRP and AMD is unknown.ObjectiveTo test the hypothesis that elevated CRP levels are associated with an increased risk for AMD.Design, Setting, and ParticipantsA total of 930 (91%) of 1026 participants at 2 centers in the Age-Related Eye Disease Study (AREDS), a multicenter randomized trial of antioxidant vitamins and minerals, were enrolled in this case-control study. There were 183 individuals without any maculopathy, 200 with mild maculopathy, 325 with intermediate disease, and 222 with advanced AMD (geographic atrophy or neovascular AMD). The AMD status was assessed by standardized grading of fundus photographs, and stored fasting blood specimens drawn between January 1996 and April 1997 were analyzed for high-sensitivity CRP levels.Main Outcome MeasureAssociation between CRP and AMD.ResultsThe CRP levels were significantly higher among participants with advanced AMD (case patients) than among those with no AMD (controls; median values, 3.4 vs 2.7 mg/L; P = .02). After adjustment for age, sex, and other variables, including smoking and body mass index, CRP levels were significantly associated with the presence of intermediate and advanced stages of AMD. The odds ratio (OR) for the highest vs the lowest quartile of CRP was 1.65 (95% confidence interval [CI], 1.07-2.55; P for trend = .02). The OR for CRP values at or above the 90th percentile (10.6 mg/L) was 1.92 (95% CI, 1.20-3.06), and the OR for CRP values at or above the mean plus 2 SDs (16.8 mg/L) was 2.03 (95% CI, 1.03-4.00). A trend for an increased risk for intermediate and advanced AMD with higher levels of CRP was seen for smokers (OR, 2.16; 95% CI, 1.33-3.49) and those who never smoked (OR, 2.03; 95% CI, 1.19-3.46) with the highest level of CRP.ConclusionOur results suggest that elevated CRP level is an independent risk factor for AMD and may implicate the role of inflammation in the pathogenesis of AMD.

Breeder cows, cattle recently arrived at feedlots, and cattle about to be shipped for slaughter were tested for Salmonella spp. No Salmonella spp. were detected in fecal samples from breeding cows. Nineteen of 1,000 (1.9%) fecal samples from recently arrived feedlot cattle were positive for Salmonella spp. compared to only 2 of 1,000 (0.2%) fecal samples taken within 2 weeks of slaughter. The positive fecal samples were collected in 5 of 50 (10%) "recent arrival" pens tested and in 1 of 50 (2%) pens tested within 2 weeks of slaughter. The serotypes isolated were Salmonella Agona, Salmonella Enteritidis, Salmonella Typhimurium DT104, and Salmonella 4,5,12:i:-. Ground beef samples purchased from retail outlets throughout Alberta were processed for Salmonella spp. Thirteen of 1,002 (1.3%) samples were positive for Salmonella spp. The serotypes isolated from ground beef were Salmonella Anatum, Salmonella Heidelberg, Salmonella Montevideo, Salmonella Typhimurium, Salmonella Typhimurium var. Copenhagen, and Salmonella Rough-O:i:1,2. The antibiotic resistance and pulsed-field electrophoresis gel macrorestriction patterns of all isolates were compared.

Objectives—While clinical practice is complicated by many ethical dilemmas, clinicians do not often request ethics consultations. We therefore investigated what triggers clinicians' requests for ethics consultation. Design—Cross-sectional telephone survey. Setting—Internal medicine practices throughout the United States. Participants—Randomly selected physicians practising in internal medicine, oncology and critical care. Main measurements—Socio-demographic characteristics, training in medicine and ethics, and practice characteristics; types of ethical problems that prompt requests for consultation, and factors triggering consultation requests. Results—One hundred and ninety of 344 responding physicians (55%) reported requesting ethics consultations. Physicians most commonly reported requesting ethics consultations for ethical dilemmas related to end-of-life decision making, patient autonomy issues, and conflict. The most common triggers that led to consultation requests were: 1) wanting help resolving a conflict; 2) wanting assistance interacting with a difficult family, patient, or surrogate; 3) wanting help making a decision or planning care, and 4) emotional triggers. Physicians who were ethnically in the minority, practised in communities under 500,000 population, or who were trained in the US were more likely to request consultations prompted by conflict. Conclusions—Conflicts and other emotionally charged concerns trigger consultation requests more commonly than other cognitively based concerns. Ethicists need to be prepared to mediate conflicts and handle sometimes difficult emotional situations when consulting. The data suggest that ethics consultants might serve clinicians well by consulting on a more proactive basis to avoid conflicts and by educating clinicians to develop mediation skills. Key Words: Ethics consultation • resolution of ethical problems • ethical conflicts

Field-grown three-year old Echinacea angustifolia roots were dried in a forced-air thin-layer (FA) dryer and in a fluidized-bed (FB) dryer. The roots were either stored in a freezer at -15C or in a cooler at 3.5C before drying. These roots were classified according to their diameter as: a) small (diameter of 3 mm or less); b) medium (diameter of 3 to 6 mm); and c) large (diameter of more than 6 mm). Roots were dried to a moisture content of 12% or 10%. Aside from root size, other variables used in drying were drying air temperature (15, 30 and 45C for freezer-stored samples; 30 and 50C for cooler-stored samples) and air velocity (0.3, 0.7 and 1.1 m/s for FA drying and 3.3 and 4.8 m/s for FB drying). Samples were taken before and after drying for moisture content determination and microbial analysis. Four drying models were fitted to the drying data. Both the Page and the two- term exponential models were found to provide good fit to the drying data. The relationship between drying time and root size as well as drying temperature was very clear. Large roots took longer to dry than medium and small roots. High drying temperature resulted in shorter drying duration. The effect of drying on the microbial load of the sample was not apparent from the results. Regardless of drying conditions, the microbial load of the sample did not appear to change after drying.

Age-related macular degeneration (AMD) is the major cause of irreversible vision loss in the Western world,1 affecting approximately 15% of the elderly. At present, there is no widely practicable treatment for AMD. It is believed that AMD is a multifactorial disease, and the risk of AMD is determined by multiple genetic and environmental (including nutritional) factors.2,3 In recent studies, we observed a link between glycemic index (GI) and increased risk for AMD in two American cohorts: the Nutrition and Vision Project (NVP) substudy of the Nurses' Health Study (NHS) and the Age-Related Eye Diseases Study (AREDS).4–6 Both studies indicate that consuming diets that cause higher blood glucose loads (i.e., diets with higher glycemic index [GI]) is associated with higher risk for AMD in otherwise healthy, nondiabetic individuals. The findings were also replicated in the Blue Mountain Eye Study (BMES) cohort, Australia.7 The GI is a physiological measure of the “glycemic quality” of carbohydrate-containing foods.8 Intake of high-GI foods results in rapid elevation of postprandial blood glucose levels relative to low-GI foods. The clinical and public health implication of GI is that it can help people to choose foods. The dietary glycemic index (dGI) for each subject was calculated as Σ (GIi × Wi)/W: the weighted average of the GI values for each food item i (GIi) with the amount of carbohydrate consumed from each food item i as the weight Wi/W.9 Thus, dGI can be thought of as a description of a dietary pattern that describes the glycemic quality of a diet. Our recent evaluations indicated that the dGI is a better correlate of AMD than is total carbohydrate intake (quantity).4–6 Our analyses also found that the association with dGI is stronger in individuals with bilateral AMD progression (more susceptible to AMD progression).6 Since bilateral AMD progression suggests a stronger genetic influence, we hypothesized that genetic variants play a epistatic or modifier role in the novel association between dGI and AMD risk.6 Specifically, we speculate that gene–carbohydrate interactions are etiologic factors for AMD.3 In this study, we investigated roles for insulin-like growth factor (IGF)–related (often referred to as the IGF axis) genes because carbohydrate nutrition has been shown to affect postprandial circulating levels of IGFs and their responses10–12 and several mechanistic studies have related these genes to choroidal neovascularization, a late-stage manifestation of AMD.13–15 To test our hypothesis, we used a candidate gene approach in a association study, to evaluate whether genetic polymorphisms in specific IGF-axis genes alter the risk of AMD.

Author(s): Lindblad, Anne S; Lloyd, Patricia C; Clemons, Traci E; Gensler, Gary R; Ferris, Frederick L; Klein, Michael L; Armstrong, Jane R; Age-Related Eye Disease Study Research Group | Abstract: ObjectiveTo characterize progression of geographic atrophy (GA) associated with age-related macular degeneration in AREDS as measured by digitized fundus photographs.MethodsFundus photographs from 181 of 4757 AREDS participants with a GA area of at least 0.5 disc areas at baseline or from participants who developed bilateral GA during follow-up were scanned, digitized, and evaluated longitudinally. Geographic atrophy area was determined using planimetry. Rates of progression from noncentral to central GA and of vision loss following development of central GA included the entire AREDS cohort.ResultsMedian initial lesion size was 4.3 mm(2). Average change in digital area of GA from baseline was 2.03 mm(2) (standard error of the mean, 0.24 mm(2)) at 1 year, 3.78 mm(2) (0.24 mm(2)) at 2 years, 5.93 mm(2) (0.34 mm(2)) at 3 years, and 1.78 mm(2) (0.086 mm(2)) per year overall. Median time to developing central GA after any GA diagnosis was 2.5 years (95% confidence interval, 2.0-3.0). Average visual acuity decreased by 3.7 letters at first documentation of central GA, and by 22 letters at year 5.ConclusionsGrowth of GA area can be reliably measured using standard fundus photographs that are digitized and subsequently graded at a reading center. Development of GA is associated with subsequent further growth of GA, development of central GA, and loss in central vision.

Objective To examine the association of dietary ω-3 long-chain polyunsaturated fatty acid and fish intake with incident neovascular age-related macular degeneration (AMD) and central geographic atrophy (CGA). Methods Multicenter clinic-based prospective cohort study from a clinical trial including Age-Related Eye Disease Study (AREDS) participants with bilateral drusen at enrollment. Main outcome measures were incident neovascular AMD and CGA, ascertained from annual stereoscopic color fundus photographs (median follow-up, 6.3 years). We estimated nutrient and food intake from a validated food frequency questionnaire (FFQ) at baseline, with intake of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), c ombined EPA and DHA, and fish as primary exposures. Results After controlling for known covariates, we observed a reduced likelihood of progression from bilateral drusen to CGA among people who reported the highest levels of EPA (odds ratio [OR], 0.44; 95% confidence interval [CI], 0.23-0.87) and EPA+DHA (OR, 0.45; 95% CI, 0.23-0.90) consumption. Levels of DHA were associated with CGA in age-, sex-, and calorie-adjusted models (OR, 0.51; 95% CI, 0.26-1.00); however, this statistical relationship did not persist in multivariable models. Conclusions Dietary lipid intake is a modifiable factor that may influence the likelihood of developing sight-threatening forms of AMD. Our findings suggest that dietary ω-3 long-chain polyunsaturated fatty acid intake is associated with a decreased risk of progression from bilateral drusen to CGA.

OBJECTIVE To evaluate the relationship of dietary carotenoids, vitamin A, alpha-tocopherol, and vitamin C with prevalent age-related macular degeneration (AMD) in the Age-Related Eye Disease Study (AREDS). METHODS Demographic, lifestyle, and medical characteristics were ascertained on 4519 AREDS participants aged 60 to 80 years at enrollment. Stereoscopic color fundus photographs were used to categorize participants into 4 AMD severity groups and a control group (participants with < 15 small drusen). Nutrient intake was estimated from a self-administered semiquantitative food frequency questionnaire at enrollment. Intake values were energy adjusted and classified by quintiles. The relationship between diet and AMD status was assessed using logistic regression analyses. RESULTS Dietary lutein/zeaxanthin intake was inversely associated with neovascular AMD (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.45-0.93), geographic atrophy (OR, 0.45; 95% CI, 0.24-0.86), and large or extensive intermediate drusen (OR, 0.73; 95% CI, 0.56-0.96), comparing the highest vs lowest quintiles of intake, after adjustment for total energy intake and nonnutrient-based covariates. Other nutrients were not independently related to AMD. CONCLUSION Higher dietary intake of lutein/zeaxanthin was independently associated with decreased likelihood of having neovascular AMD, geographic atrophy, and large or extensive intermediate drusen.

OBJECTIVE To evaluate the association of lipid intake with baseline severity of age-related macular degeneration (AMD) in the Age-Related Eye Disease Study (AREDS). METHODS Age-Related Eye Disease Study participants aged 60 to 80 years at enrollment (N = 4519) provided estimates of habitual nutrient intake through a self-administered semiquantitative food frequency questionnaire. Stereoscopic color fundus photographs were used to categorize participants into 4 AMD severity groups and a control group (participants with

Rapid and molecular technologies such as enzyme-linked immunosorbent assay (ELISA), PCR, and lateral flow immunoprecipitation can reduce the time and labor involved in screening food products for the presence of pathogens. These technologies were compared with conventional culture methodology for the detection of Salmonella, Campylobacter, Listeria, and Escherichia coli O157:H7 inoculated in raw and processed meat and poultry products. Recommended protocols were modified so that the same enrichment broths used in the culture methods were also used in the ELISA, PCR, and lateral flow immunoprecipitation assays. The percent agreement between the rapid technologies and culture methods ranged from 80 to 100% depending on the pathogen detected and the method used. ELISA, PCR, and lateral flow immunoprecipitation all performed well, with no statistical difference, compared with the culture method for the detection of E. coli O157:H7. ELISA performed better for the detection of Salmonella, with sensitivity and specificity rates of 100%. PCR performed better for the detection of Campylobacter jejuni, with 100% agreement to the culture method. PCR was highly sensitive for the detection of all the foodborne pathogens tested except Listeria monocytogenes. Although the lateral flow immunoprecipitation tests were statistically different from the culture methods for Salmonella and Listeria because of false-positive results, the tests did not produce any false negatives, indicating that this method would be suitable for screening meat and poultry products for these pathogens.