Intravenous iron administration does not significantly increase the risk of bacteremia in chronic hemodialysis patients.

BACKGROUND: Correction of iron deficiency is critical in chronic hemodialysis patients, and intravenous administration is superior to the oral route in this goal. Recently, concern was raised that intravenous iron administration might promote infection in dialysis patients. METHODS: We reviewed the data from a recent prospective study of 985 patients in which no link between iron therapy and bacteremia had been found. We tested the potential role of the administration route of the iron (intravenous vs. oral), the weekly amount of iron administered and the administration rate on the risk for bacteremia in these patients. RESULTS: were 4-fold: in multivariate analysis, neither intravenous iron administration in the whole population nor the weekly amount of iron in the subgroup of i.v. iron-treated patients were significant risk factors for bacteremia; iron was not given more frequently intravenously in bacteremic than in non-bacteremic patients; among patients treated with intravenous iron, the frequency and the amount of iron administered were significantly higher in those who developed bacteremia than in those who did not; and in patients receiving i.v. iron, there was an increased risk of bacteremia associated with concurrent administration of erythropoietin, which was not observed in patients receiving iron orally. CONCLUSION: This study failed to demonstrate a significant association between intravenous iron administration and the risk of bacteremia in dialysis patients. However, there might be a slightly increased risk of bacteremia in patients given high-frequency, high-dose intravenous iron.

[Characteristics of a cohort of 4,000 French patients with angina. The ELAN study]. / Caractéristiques d'une cohorte française de 4,000 patients angineux. L'étude ELAN.

The ELAN (Etude Longitudinale dans l'ANgor) study was carried out to evaluate factors influencing the occurrence of death, myocardial infarction and revascularization procedures in patients with known angina pectoris. Analysis of baseline data collected in January 1997 involves 4,035 patients throughout France, which were recruited by 613 cardiologists practising on a private, hospital or mixed basis. The study population comprised 75% of men with a mean age of 65 years and 25% of women with a mean age of 70 years. Eighty eight percent of the patients had at least one cardiovascular risk factor, and nearly half of them had two or more factors; hypercholesterolemia and hypertension were the two most frequent ones. Reported cardiovascular past events included myocardial infarction in 47% of patients, PTCA in 33% and aorto-coronary bypass in 24%. Angina pectoris had been diagnosed within the previous year in 39% of patients. Exertional angina was the most common type (66%), with grade I/II angina being most frequently found (more than 70% of all cases). Management strategies are especially described for angina patients diagnosed within the previous year. More than half of the patients had undergone exercise testing within the previous 12 months, while scanning and coronary arteriography had been performed in 15% and 72%, respectively. Ninety five percent of patients were under antianginal drug therapy, with combined therapies being used in 58% of them. The most frequently prescribed drugs were betablockers (63%) and nitrates (53%). In 74% of patients, aspirin was given in addition to conventional antianginal agents. These data will be reviewed in a one-year cohort analysis as potential predictive factors for the occurrence of cardiovascular events.

[One-year follow-up of a population of patients with angina. Factors influencing mortality and occurrence of cardiovascular events. Results of the ELAN study]. / Le devenir à un an d'une population de patients angineux. Facteurs influençant la mortalité et la survenue des événements cardiovasculaires. Les résultats de l'étude ELAN.

The ELAN (Etude longitudinale dans l'angor) study was carried out both to acquire better knowledge of the occurrence of major cardiovascular events (myocardial infarction, revascularization surgery, death) in patients followed up for angina pectoris, and to determine the factors influencing such events. A cohort of angina patients was formed in January 1997, and 3,284 patients were followed up by 488 French cardiologists during a one-year period. Of these 3,284 patients, 96 (29/1000) died; causes of death included underlying coronary heart disease in 31, sudden death in 8, other cardiac aetiologies in 35, and noncardiac causes in 22. Sixty-nine (21/1000) patients developed myocardial infarction, 240 (73/1000) underwent PTCA, and 119 (36/1000) underwent coronary bypass surgery. Factors associated with an increased risk of death were age, diabetes mellitus, heart failure and angina type, mixed and rest angina being associated with poorer prognosis compared to exertional angina. Infarction risk increased with age and a history of previous infarction. Analysis of therapeutic factors after adjustment for the above risk factors showed a beneficial effect of betablockers on both cardiovascular and all-cause mortality and of aspirin on all-cause mortality.

Selection of quality-of-life measures for a prevention trial: a psychometric analysis.

Quality-of-life (QoL) outcomes have become increasingly important in the evaluation of health interventions. The objective of the present study was to determine which of three generic QoL instruments was most suitable for use in an 8-year nutritional primary prevention trial. We compared the Duke Health Profile, the Nottingham Health Profile, and the Short Form Health Survey Questionnaire (SF36). We conducted the comparison in two stages: (1) a statistical analysis of data from a pilot study (n = 963) comparing the psychometric properties of the three instruments; and (2) an assessment of the practicality of the tools. With regard to psychometric properties, convergent validity was comparable for the three scales, and the correlation with Global Health Assessment ranged from 0.24 to 0.72. Discriminant validity was best for the SF36, with a difference between scores in healthy subjects and those with chronic disease in the range of 4.4 to 15.8 (scores could range from 0 to 100, where 100 indicates perfect health). Reproducibility was good for all three instruments, with a test-retest intraclass correlation coefficient of over 0.60 for most dimensions. DHP and SF36 performed best in terms of responsiveness. We judged the practicality of the three tools as satisfactory. We chose the SF36 for its high responsiveness. We also selected the Duke Health Profile for its practicality and favorable psychometric properties.

Bias and precision in visual analogue scales: a randomized controlled trial.

Various types of visual analogue scales (VAS) are used in epidemiologic and clinical research. This paper reports on a randomized controlled trial to investigate the effects of variations in the orientation and type of scale on bias and precision in cross-sectional and longitudinal analyses. This trial was included in the pilot study of the SU.VI.MAX (supplementation by antioxidant vitamins and minerals) prevention trial in France in 1994. Six types of VAS (simple, middle-marked, graphic rating, graduated, graduated-numbered, and numerical rating) and two orientations (horizontal and vertical) were used to measure three symptoms of ear, nose, and throat infection at 2-month intervals in 870 subjects. Differences between scales were analyzed by comparing variances (Levene's test) and means (variance-covariance analysis for repeated measures). Scale characteristics were shown to influence the proportion of zero and low values (i.e., there was a floor effect), but not mean scores. The precision of measurements varied cross-sectionally according to the type of scale, but no differences were observed in the precision of measurement of change over time. In conclusion, the characteristics of VAS seem to be important in cross-sectional studies, particularly when symptoms of low or high intensity are being measured. Researchers should try to reach a consensus on what type of VAS to use if studies are to be compared.

Effects of supplementation with a combination of antioxidant vitamins and trace elements, at nutritional doses, on biochemical indicators and markers of the antioxidant system in adult subjects.

OBJECTIVE: To test the impact of supplementation with nutritional doses of antioxidant nutrients on biochemical indicators of vitamin and trace element levels. DESIGN: A randomized double-blind trial was performed comparing two groups receiving daily either a combination of vitamins (beta-carotene, 6 mg; vitamin C, 120 mg; and vitamin E, 30 mg) and trace elements (zinc, 20 mg; and selenium, 100 micrograms); or a placebo. SUBJECTS: 401 subjects (166 males aged 45 to 60 years and 235 females aged to 35 to 60 years). MEASURE OF OUTCOME: Biological markers of vitamin and trace element status and free radical parameters were measured initially, 3 months, and 6 months after supplemention. RESULTS: Mean serum concentrations of alpha-tocopherol, vitamin C, beta-carotene, zinc and selenium increased significantly after 3 months of supplementation in the group receiving multivitamins associated with minerals. At baseline, 18.2% of the men and 5.1% of the women had low concentrations of serum vitamin C (< 20 mumol/l): 2.4% of the men and 17% of the women presented low concentrations of serum retinol (< 1.4 mumol/l): 18.7% of men and 10% of women had serum beta-carotene < 0.30 mumol/l. None of the study subjects had serum alpha-tocopherol concentrations below the limit cut-off point (< 9.3 mumol/l). Low serum zinc concentrations (< 10.7 mumol/l) were found in 15.1% of men and 23.8% of women. Low serum selenium concentrations (< 0.75 mumol/l) were found in 6% of men and 6.4% of women. A significant increase in plasma and red cell GPx activity was observed in groups receiving supplementation. No modifications were observed after 6 months of supplementation for malondyaldehyde. CONCLUSION: This study demonstrates the efficacy of an intake of antioxidant vitamins and trace elements, given at nutritional doses, on biochemical indicators of vitamin and trace elements status.

EPIBACDIAL: a multicenter prospective study of risk factors for bacteremia in chronic hemodialysis patients.

Bacteremic infections are a major cause of mortality and morbidity in chronic hemodialysis patients. New developments in managing these patients (erythropoietin therapy, nasal mupirocin, long-term implanted catheters, and synthetic membranes) may have altered the epidemiologic patterns of bacteremia in dialysis patients. This multicenter prospective cross-sectional study was carried out to determine the current incidence of and risk factors for bacteremia in chronic hemodialysis patients in France. A total of 988 adults on chronic hemodialysis for 1 mo or longer was followed up prospectively for 6 mo in 19 French dialysis units. The factors associated with the development of at least one bacteremic episode over 6 mo were determined using the multivariate Cox proportional hazards model. Staphylococcus aureus (n=20) and coagulase-negative staphylococci (n=15) were responsible for most of the 51 bacteremic episodes recorded. The incidence of bacteremia was 0.93 episode per 100 patient-months. Four risk factors for bacteremia were identified: (1) vascular access (catheter versus fistula: RR=7.6; 95% CI, 3.7 to 15.6); (2) history of bacteremia (> or =2 versus no previous episode: RR=7.3; 95% CI, 3.2 to 16.4); (3) immunosuppressive therapy (current versus no: RR=3.0; 95% CI, 1.0 to 6.1); and (4) corpuscular hemoglobin (per 1 g/dl increment: RR=0.7; 95% CI, 0.6 to 0.9). Catheters, especially long-term implanted catheters, were found to be the leading risk factor of bacteremia in chronic hemodialysis patients. There was a trend toward recurrence of bacteremia that was not associated with chronic staphylococcal nasal carriage. Synthetic membranes were not associated with a lower risk of bacteremia in this population of well dialyzed patients, but anemia linked to resistance to erythropoietin appeared to be a possible risk factor for bacteremia.

Background and rationale behind the SU.VI.MAX Study, a prevention trial using nutritional doses of a combination of antioxidant vitamins and minerals to reduce cardiovascular diseases and cancers. SUpplementation en VItamines et Minéraux AntioXydants Study.

The "SUpplementation en VItamines et MinérauxAntioXydants" (SU.VI.MAX) study is a randomized double-blind, placebo-controlled, primary prevention trial designed to test the efficacy of daily supplementation with antioxidant vitamins (vitamin C, 120 mg; vitamin E, 30 mg; and beta-carotene, 6 mg) and minerals (selenium, 100 micrograms; and zinc, 20 mg), at nutritional doses (one to three times the daily recommended dietary allowances), in reducing the frequency of major health problems in industrialized countries, and especially the main causes of premature death (cancers and cardiovascular diseases). The study involves 12,735 eligible subjects (women aged 35 to 60 years; men aged 45 to 60 years) included in 1994 in France. They will be followed up for 8 years. The objectives and the specific design of this intervention study are linked to its public health aim. The targeted population is the general population (not simply high-risk subjects) and the antioxidant agents tested are being administered at a level which is not pharmacologic and which may be attained by dietary intake of natural sources of these micronutrients and/or enriched foods. The amounts we are testing in the SU.VI.MAX study are those which, in observational studies have been associated with the lowest risk of diseases. This report presents the rationale and discusses the justification of the design, doses and combination of antioxidant micronutrients chosen in the SU.VI.MAX study.

Diet, antioxidant status, and smoking habits in French men.

The aim of this study was to assess the association between smoking, food consumption, and antioxidant vitamin intake and plasma indexes of oxidative stress and antioxidant defenses in French adults. Food and nutrient intakes of 459 healthy men aged 23-57 y were estimated by the diet history method and analyzed by smoking status. Plasma alpha-tocopherol, ascorbic acid, and carotenoids were measured as antioxidants and malondialdehyde, protein Schiff bases, and autoantibodies against malondialdehyde-protein adducts as oxidative stress indexes. Smokers ate less fruit and vegetables than nonsmokers, leading to lower vitamin E, vitamin C, and carotene intakes, even after adjustment for age, education, and marital status. Unlike vitamin E, plasma ascorbic acid and beta-carotene concentrations were reduced in smokers compared with nonsmokers and were inversely related to cigarette consumption. This difference remained significant after adjustment for alcohol and dietary intakes. Among the measured oxidative stress indexes, only Schiff base concentration was positively related to the number of cigarettes smoked. In our sample of French men, smoking had an adverse effect on antioxidant status; vitamin intakes were reduced in smokers and plasma antioxidant indexes were altered independently of dietary intakes. As in other countries, in France smokers require particular attention in terms of public health intervention.

[The DUKE health profile: a generic instrument to measure the quality of life tied to health]. / Le Profil de santé de DUKE: un instrument générique de mesure de qualité de vie liée à la santé.

To adapt the DUKE Health Profile, a 17-item self-report generic health related quality of life measure cross-culturally in french. A multidisciplinary expert committee was provided with three translations independent of each other, each backtranslated to the original language, and produced a synthesis version equivalent to the original. A cohort of 963 persons from the general population filled in the questionnaire twice in three months. The internal consistency was acceptable (Cronbach's alpha = 0.63-0.81) except in social dimension. Convergent validity was evidenced by a significant correlation with overall health. The test-retest reproducibility in stable subjects (601) was satisfactory (intraclass coefficient correlation r = 0.63-0.78) except in pain and disability dimensions. There was a significant modification of scores in the same direction as overall health change in subjects improved (n = 128) or worsened (n = 187). Age-adjusted scores were lower in females, in subjects with lower education, urban residency, unemployed and living alone and in subjects reporting a chronic disease. This short form questionnaire similar to the original version proved simple to use in the general population.