SEARCH · PubMed Health

Results for “EPIC”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 109 records · Page 6Linked to original sources

PubMed2003

EPIC-Oxford: lifestyle characteristics and nutrient intakes in a cohort of 33 883 meat-eaters and 31 546 non meat-eaters in the UK.

OBJECTIVE: To describe the lifestyle characteristics and nutrient intakes of the Oxford cohort of the European Prospective Investigation into Cancer and Nutrition (EPIC). DESIGN: Cohort of men and women recruited through general practices or by post to include a high proportion of non meat-eaters. Dietary, anthropometric and lifestyle data were collected at baseline and four diet groups were defined. SETTING: United Kingdom. PARTICIPANTS: In total, 65 429 men and women aged 20 to 97 years, comprising 33 883 meat-eaters, 10 110 fish-eaters, 18 840 lacto-ovo vegetarians and 2596 vegans. RESULTS: Nutrient intakes and lifestyle factors differed across the diet groups, with striking differences between meat-eaters and vegans, and fish-eaters and vegetarians usually having intermediate values. Mean fat intake in each diet group was below the UK dietary reference value of 33% of total energy intake. The mean intake of saturated fatty acids in vegans was approximately 5% of energy, less than half the mean intake among meat-eaters (10-11%). Vegans had the highest intakes of fibre, vitamin B1, folate, vitamin C, vitamin E, magnesium and iron, and the lowest intakes of retinol, vitamin B12, vitamin D, calcium and zinc. CONCLUSIONS: The EPIC-Oxford cohort includes 31 546 non meat-eaters and is one of the largest studies of vegetarians in the world. The average nutrient intakes in the whole cohort are close to those currently recommended for good health. Comparisons of the diet groups show wide ranges in the intakes of major nutrients such as saturated fat and dietary fibre. Such variation should increase the ability of the study to detect associations of diet with major cancers and causes of death.

Adult↗

PubMed2004

Accuracy of self-reported waist and hip measurements in 4492 EPIC-Oxford participants.

OBJECTIVE: To assess the accuracy of self-reported waist and hip circumferences and the waist-to-hip ratio (WHR) by comparison with measured waist and hip circumferences and WHR in a sample of middle-aged men and women. DESIGN: Analysis of measured and self-reported waist and hip data from participants in the Oxford cohort of the European Prospective Investigation into Cancer and Nutrition (EPIC-Oxford). PARTICIPANTS: Four thousand four hundred and ninety-two British men and women aged 35-76 years. RESULTS: Spearman's rank correlation coefficients between measured and self-reported waist, hip and WHR were 0.80, 0.74 and 0.44, respectively, for men and 0.83, 0.86 and 0.62 for women. Waist was underestimated, on average, by 3.1 (standard deviation (SD) 5.6) cm in men and 1.9 (SD 5.4) cm in women. The extent of underestimation was greater in participants with larger waists, older participants and women with greater body mass index (BMI). Hip was underestimated by a mean of 1.8 (SD 4.9) cm in men and 1.2 (SD 4.5) cm in women; the extent of underestimation was greater in participants with larger hip circumference and older participants. On average, WHR was underestimated by less than 2% by men and women; the extent of underestimation was greater among those with larger WHR, older people and those with greater BMI. Using self-reported values, the proportion of classification to the correct tertile was over 65% for waist and hip measurements. For WHR this proportion was 50% among men and 60% among women. CONCLUSIONS: Self-reported waist and hip measurements in EPIC-Oxford are sufficiently accurate for identifying relationships in epidemiological studies.

Adult↗

PubMed2006

The European Prospective Investigation into Cancer and Nutrition (EPIC).

OBJECTIVE: To describe the main finding produced so far by the EPIC project, which aims to improve the scientific knowledge of nutritional factors involved in cancer. DESIGN AND SETTING: Prospective cohort study in 23 centres from 10 European countries. Dietary assessment method varied by countries: in some cases a diet history by personal interview was carried out, while in most countries a self-administered semi-quantitative food-frequency questionnaire was used; in one case the questionnaire was combined with a food record. Information on a wide range of lifestyle factors and anthropometric measurements were also collected for most participants. SUBJECTS: The cohort includes 521,468 men and women mostly aged between 39 and 69 years, whereas blood samples are available for 387,889 subjects. RESULTS: To date 24 185 cancer cases have been identified in the follow-up of the cohort. The publications produced by each centre can be consulted on the EPIC website (http://www.iarc.fr/epic/). Among initial findings concerning the associations between cancer and dietary factors, one of the most important results is a protective effect of high fibre intake and fish consumption against colorectal cancer, while high red and processed meat intake increase the risk. Regarding lung cancer the first analyses found a protective effect of fruit intake but no association with vegetable consumption. No association was observed between vegetables and fruit intake and the risk of prostate cancer or breast cancer. Finally, data from Cambridge point to an interesting result regarding breast cancer: no association was observed with saturated fat intake measured by food-frequency questionnaire, but according to the food diary a daily intake of 35 g doubles the risk of breast cancer compared to women with daily intake of 10 g or less.

Adult↗

PubMed2003

Preventing central venous catheter-associated primary bloodstream infections: characteristics of practices among hospitals participating in the Evaluation of Processes and Indicators in Infection Control (EPIC) study.

OBJECTIVES: To describe the conceptual framework and methodology of the Evaluation of Processes and Indicators in Infection Control (EPIC) study and present results of CVC insertion characteristics and organizational practices for preventing BSIs. The goal of the EPIC study was to evaluate relationships among processes of care, organizational characteristics, and the outcome of BSI. DESIGN: This was a multicenter prospective observational study of variation in hospital practices related to preventing CVC-associated BSIs. Process of care information (eg, barrier use during insertions and experience of the inserting practitioner) was collected for a random sample of approximately 5 CVC insertions per month per hospital during November 1998 to December 1999. Organization demographic and practice information (eg, surveillance activities and staff and ICU nurse staffing levels) was also collected. SETTING: Medical, surgical, or medical-surgical ICUs from 55 hospitals (41 U.S. and 14 international sites). PARTICIPANTS: Process information was obtained for 3,320 CVC insertions with an average of 58.2 (+/- 16.1) insertions per hospital. Fifty-four hospitals provided policy and practice information. RESULTS: Staff spent an average of 13 hours per week in study ICU surveillance. Most patients received nontunneled, multiple lumen CVCs, of which fewer than 25% were coated with antimicrobial material. Regarding barriers, most clinicians wore masks (81.5%) and gowns (76.8%); 58.1% used large drapes. Few hospitals (18.1%) used an intravenous team to manage ICU CVCs. CONCLUSIONS: Substantial variation exists in CVC insertion practice and BSI prevention activities. Understanding which practices have the greatest impact on BSI rates can help hospitals better target improvement interventions.

Catheterization, Central Venous↗

PubMed1997

Relative validity and reproducibility of a food frequency dietary questionnaire for use in the Italian EPIC centres.

A pilot questionnaire was developed for the EPIC centres of northern Italy, and validated in the feasibility part of the cohort project. The questionnaire was self-administered and of the food frequency type with portion size estimated by means of pictures. It was structured by courses within a meal characteristic of Italian dietary habits. Dietary intake estimated by the questionnaire was compared to the corresponding estimates obtained from 8-14 24-hour recall interviews administered over a 1-year period. The reference method was validated by means of urinary nitrogen in 4-6 repeated 24-hour urine collections. One hundred and ninety-seven volunteers (47 men and 150 women) were enrolled and completed the study lasting 1 year. They filled out two questionnaires at the beginning and at the end of the study, and had a 24-hour recall interview once a month. Twenty-four-hour urine samples were collected at regular intervals. Usual intake of energy, the major nutrients and some vitamins were estimated for the questionnaires and the reference method by means of food composition tables compiled for this study. The agreement between the questionnaire and the 24-hour recalls was only good for alcohol consumption: Pearson's correlation was 0.73 and 0.77 in men and women respectively. Otherwise the relative validity of the questionnaire ranged between 0.28 for fat to 0.52 for carbohydrates in men and 0.25 and 0.50 in women for the same nutrients. The validity of the two interview methods in estimating protein intake, compared to mean urinary nitrogen was 0.24 (M) and 0.18 (W) for the questionnaire and 0.63 (M) and 0.48 (W) for 24-hour recalls. The main causes of low performance of the questionnaire were identified to be the estimated intake of dressing and cooking fats, vegetables and meat. Remedies were devised and introduced in the final version of the questionnaire currently in use in the EPIC project.

Cohort Studies↗

PubMed1997

The Dutch EPIC food frequency questionnaire. I. Description of the questionnaire, and relative validity and reproducibility for food groups.

BACKGROUND: A self-administered food frequency questionnaire was developed for the Dutch cohort of the European Prospective Investigation into Cancer and Nutrition (EPIC). Habitual consumption of 178 food items can be calculated from the questionnaire data. METHODS: Reproducibility and relative validity for food group intake were investigated in a population of 121 Dutch men and Women. The questionnaire was administered three times at 6-month intervals in order to determine the reproducibility. To assess the relative validity 12 monthly 24-hour recalls served as the reference method. RESULTS: Spearman rank order correlation coefficients between estimates of food group intake assessed by repeated questionnaires ranged from 0.45 to 0.92. For men, Spearman correlation coefficients between estimates of food group intake based on the questionnaire and those based on 24-hour recalls ranged from 0.21 for cooked vegetables to 0.78 for sugar and sweet products, with a range of 0.61. For women the median was 0.53, with a minimum of 0.31 for vegetables and a maximum of 0.87 for alcoholic beverages. The photographs in the questionnaire for the estimation of portion sizes contributed little to the relative validity of the ranking of subjects. However, on the group level most median food group estimates based on photographic portion sizes were closer to the median intakes as assessed by 24-hour recalls than those based on standard portion sizes. CONCLUSIONS: The questionnaire seems adequate for ranking Dutch EPIC subjects according to intake of most food groups, although the relative validity for some food groups, such as vegetables and fish, remains of concern.

Adult↗

PubMed1997

Reproducibility and relative validity of food group intake in a food frequency questionnaire developed for the German part of the EPIC project. European Prospective Investigation into Cancer and Nutrition.

BACKGROUND: For the German part of the European Prospective Investigation into Cancer and Nutrition (EPIC), a self-administered, optically-readable food frequency questionnaire (FFQ), including 158 food items and 87 coloured portion size photographs, was developed to assess the usual food and nutrient intake of individuals during the past year. In 1991/1992, the reproducibility and validity of the questionnaire measurements were studied according to the EPIC protocol. This article reports the results on reproducibility and relative validity of measurement of food group intake. METHODS: A total of 104 men and women aged 35-64 years, who are members of the local health insurance institution, AOK Heidelberg, participated in this study. Reproducibility of the questionnaire measurements was obtained by a repeated administration of the FFQ to the same study subjects at a 6-month interval. The mean of 12 24-hour dietary recalls applied at monthly intervals served as reference method for the estimation of the relative validity of questionnaire measurements. A second version of the FFQ that integrated questions on general food consumption patterns was also investigated. RESULTS: Spearman test-retest correlations of food group intake ranged from 0.49 for bread to 0.89 for alcoholic beverages (median = 0.70). Spearman correlations between food group intake values derived from the 24-hour diet recalls and the FFQ completed in the summer of 1992 varied from 0.14 for legumes to 0.90 for alcoholic beverages (median = 0.45). Correction for attenuation due to within-person error in the reference method as well as the correction for general consumption patterns improved the correlations. CONCLUSION: The results indicate that our newly developed FFQ gives reproducible estimates of food group intake. Large day-to-day variation in food group intake complicated the evaluation of FFQ validity. Overall, moderate levels of relative validity were observed for estimates of food group intake.

Adult↗

PubMed1997

Reproducibility and relative validity of energy and macronutrient intake of a food frequency questionnaire developed for the German part of the EPIC project. European Prospective Investigation into Cancer and Nutrition.

BACKGROUND: For use in the German part of the European Prospective Investigation into Cancer and Nutrition (EPIC) a self-administered, optically readable food frequency questionnaire (FFQ) was developed to assess individuals' usual food and nutrient intake over the past year. The food list comprised 158 food items for which the typical portion size, the consumption frequency (1-6 times) and the time period (day, week, month, or year) were requested. This paper reports the results of the reproducibility and relative validity of nutrient intakes obtained by this instrument. METHODS: The study was carried out from October 1991 to October 1992. During this period, 104 men and women, aged 35-64 years, completed a 24-hour recall once a month, and the FFQ in the middle and at the end of this study. A short questionnaire on global consumption patterns was used to adjust the food consumption frequency given in the FFQ. RESULTS: Reproducibility correlations varied from 0.59 for saturated fat to 0.88 for alcohol, with most values falling between 0.60 and 0.70. Energy-adjustment decreased the observed correlations for all nutrients. Correlations between nutrient intake values from the 12-day average of dietary recalls and the FFQ corrected for food consumption frequency ranged from 0.42 for polyunsaturated fat to 0.88 for alcohol, followed by 0.65 for dietary fibres. After de-attenuation and energy-adjustment the range of correlations was somewhat wider (0.43-0.75, without alcohol). With regard to classification, on average, 36% of subjects fell into the same quintile, and 75% into within-one quintile when classified by the frequency-corrected FFQ compared to the quintiles based on recalled data. CONCLUSIONS: In summary, the newly developed FFQ showed fairly good reproducibility and relative validity for most evaluated nutrients. The between-subject variation of nutrients in the German cohort (including the participants from East Germany) is likely to be greater than that among the subjects of the pilot phase. A revised version of the FFQ corrected for food consumption frequency is used in the EPIC study.

Adult↗

PubMed2002

Validity and repeatability of the EPIC-Norfolk Physical Activity Questionnaire.

BACKGROUND: Physical activity is an important lifestyle which is often poorly assessed in epidemiological studies. The European Prospective Investigation into Cancer Study-Norfolk cohort (EPIC-Norfolk), a large population-based cohort study, has developed a comprehensive questionnaire to assess activity in different domains of life aimed at assessing total energy expenditure. We report the repeatability of this instrument and its validity against repeated objective measures of fitness and energy expenditure undertaken throughout the time frame of reference of the questionnaire. METHODS: The validity of the instrument was measured in 173 individuals randomly selected from a continuing population-based cohort study. Energy expenditure was assessed by four separate episodes of 4-day heart-rate monitoring, a method previously validated against whole body calorimetry and doubly-labelled water. Cardio-respiratory fitness was assessed by four repeated measures of sub-maximum oxygen uptake. At the end of the 12-month period, participants completed the physical activity questionnaire that assesses past-year activity at home, work and in recreation. Repeatability was assessed in a separate group of 399 randomly selected participants in EPIC who completed the physical activity questionnaire twice with a 3-month interval. RESULTS: The age- and sex-adjusted correlation between the objective measure of daytime energy expenditure and the sum of recreational and occupational reported physical activity (in MET h per week) was 0.28 (P < 0.001). The reported time spent in vigorous activity was correlated with cardio-respiratory fitness (0.16, P < 0.05) and with the proportion of time when energy expenditure was more than five times basal (0.17, P < 0.05). The repeatability of the sum of recreational and occupational reported activity was high, r = 0.73. CONCLUSIONS: The indices of physical activity derived from this questionnaire have levels of validity and repeatability comparable to other physical activity instruments that are used in large epidemiological studies and which have undergone such intense development and testing.

Aged↗

PubMed2006

Meat intake and risk of stomach and esophageal adenocarcinoma within the European Prospective Investigation Into Cancer and Nutrition (EPIC).

BACKGROUND: Dietary factors are thought to have an important role in gastric and esophageal carcinogenesis, but evidence from cohort studies for such a role is lacking. We examined the risks of gastric cancer and esophageal adenocarcinoma associated with meat consumption within the European Prospective Investigation Into Cancer and Nutrition (EPIC) cohort. METHODS: A total of 521,457 men and women aged 35-70 years in 10 European countries participated in the EPIC cohort. Dietary and lifestyle information was collected at recruitment. Cox proportional hazard models were used to examine associations between meat intake and risks of cardia and gastric non-cardia cancers and esophageal adenocarcinoma. Data from a calibration substudy were used to correct hazard ratios (HRs) and 95% confidence intervals (CIs) for diet measurement errors. In a nested case-control study, we examined interactions between Helicobacter pylori infection status (i.e., plasma H. pylori antibodies) and meat intakes. All statistical tests were two-sided. RESULTS: During a mean follow-up of 6.5 years, 330 gastric adenocarcinoma and 65 esophageal adenocarcinomas were diagnosed. Gastric non-cardia cancer risk was statistically significantly associated with intakes of total meat (calibrated HR per 100-g/day increase = 3.52; 95% CI = 1.96 to 6.34), red meat (calibrated HR per 50-g/day increase = 1.73; 95% CI = 1.03 to 2.88), and processed meat (calibrated HR per 50-g/day increase = 2.45; 95% CI = 1.43 to 4.21). The association between the risk of gastric non-cardia cancer and total meat intake was especially large in H. pylori-infected subjects (odds ratio per 100-g/day increase = 5.32; 95% CI = 2.10 to 13.4). Intakes of total, red, or processed meat were not associated with the risk of gastric cardia cancer. A positive but non-statistically significant association was observed between esophageal adenocarcinoma cancer risk and total and processed meat intake in the calibrated model. In this study population, the absolute risk of development of gastric adenocarcinoma within 10 years for a study subject aged 60 years was 0.26% for the lowest quartile of total meat intake and 0.33% for the highest quartile of total meat intake. CONCLUSION: Total, red, and processed meat intakes were associated with an increased risk of gastric non-cardia cancer, especially in H. pylori antibody-positive subjects, but not with cardia gastric cancer.

Adenocarcinoma↗

PubMed2003

Time trends in cigarette smoking in two German cohorts--results from EPIC Germany.

Smoking prevention is less advanced in Germany compared with other European and North American countries, and fewer data exist, especially on the consumption habits at the individual level over time. EPIC Germany, which is part of a European multicentre study on diet and cancer, collected data on individual smoking behaviour and allows for consideration of the changing consumption pattern for both centres and different age groups. Within EPIC 25 546 and 27 548 participants, respectively, were recruited in Heidelberg and Potsdam. Data on smoking habits were collected by means of a computer-guided interview during the baseline examination between 1994 and 1998. For each birth cohort smoking prevalence and mean number of cigarettes smoked per day at different ages were calculated. Additionally, the prevalence of non-filter cigarette smoking was computed. Smoking prevalence in the 1990s was still higher among men (Heidelberg 16.3-32.3%; Potsdam 18.2-29.3%) than among women (Heidelberg 12.8-32.0%; Potsdam 10.4-27.8%). However, the percentage of women smokers was still increasing. Filter cigarettes comprised a growing percentage of the cigarettes smoked, but especially among men differences between both German cohorts can still be seen: depending on age, 10.0-12.7% of men in the Heidelberg cohort smoked non-filter cigarettes, but only 1.1-2.3% in the Potsdam cohort. The quantity smoked was higher in the Heidelberg than in the Potsdam cohort with respect to the mean number of cigarettes smoked per day as well as the pack-years of smoking. In conclusion, smoking habits in the Potsdam and the Heidelberg cohorts did not strongly differ by smoking prevalence. However, they did differ according to the quantity and quality of smoking. These differences, as well as the changes over the last 40 years may contribute to a changing pattern of diseases in different groups of the German population.

Adult↗

PubMed2005

Environmental tobacco smoke and risk of respiratory cancer and chronic obstructive pulmonary disease in former smokers and never smokers in the EPIC prospective study.

OBJECTIVES: To investigate the association between environmental tobacco smoke, plasma cotinine concentration, and respiratory cancer or death. DESIGN: Nested case-control study within the European prospective investigation into cancer and nutrition (EPIC). PARTICIPANTS: 303,020 people from the EPIC cohort (total 500,000) who had never smoked or who had stopped smoking for at least 10 years, 123,479 of whom provided information on exposure to environmental tobacco smoke. Cases were people who developed respiratory cancers or died from respiratory conditions. Controls were matched for sex, age (plus or minus 5 years), smoking status, country of recruitment, and time elapsed since recruitment. MAIN OUTCOME MEASURES: Newly diagnosed cancer of lung, pharynx, and larynx; deaths from chronic obstructive pulmonary disease or emphysema. Plasma cotinine concentration was measured in 1574 people. RESULTS: Over seven years of follow up, 97 people had newly diagnosed lung cancer, 20 had upper respiratory cancers (pharynx, larynx), and 14 died from chronic obstructive pulmonary disease or emphysema. In the whole cohort exposure to environmental tobacco smoke was associated with increased risks (hazard ratio 1.30, 95% confidence interval 0.87 to 1.95, for all respiratory diseases; 1.34, 0.85 to 2.13, for lung cancer alone). Higher results were found in the nested case-control study (odds ratio 1.70, 1.02 to 2.82, for respiratory diseases; 1.76, 0.96 to 3.23, for lung cancer alone). Odds ratios were consistently higher in former smokers than in those who had never smoked; the association was limited to exposure related to work. Cotinine concentration was clearly associated with self reported exposure (3.30, 2.07 to 5.23, for detectable/non-detectable cotinine), but it was not associated with the risk of respiratory diseases or lung cancer. Frequent exposure to environmental tobacco smoke during childhood was associated with lung cancer in adulthood (hazard ratio 3.63, 1.19 to 11.11, for daily exposure for many hours). CONCLUSIONS: This large prospective study, in which the smoking status was supported by cotinine measurements, confirms that environmental tobacco smoke is a risk factor for lung cancer and other respiratory diseases, particularly in ex-smokers.

Adult↗

PubMed2000

Psychosocial aetiology of chronic disease: a pragmatic approach to the assessment of lifetime affective morbidity in an EPIC component study.

OBJECTIVES: The Health and Life Experiences Questionnaire (HLEQ) was developed for use in a prospective cohort study of 25,000 men and women living in Norfolk and forms a component study of the European Prospective Investigation into Cancer and Nutrition (EPIC). The HLEQ includes an assessment of mood status over the life course allowing a limited capacity for the imposition of diagnostic criteria to enable eventual evaluation of mental health status for chronic disease outcomes. This paper reports estimates of HLEQ Major Depressive Disorder (MDD) prevalence and compares them with those obtained through interviewer-based methods. In addition evidence for the impact of recall, clustering or cohort effects on these estimates are examined. PARTICIPANTS: 3491 eligible respondents to EPIC in Norfolk, aged 45-74 years, recruited from the first five general practices who completed the HLEQ. MAIN RESULTS: MDD prevalence estimates were found to be closely comparable to those obtained recently (by interview) in the UK and to those lifetime MDD rates determined through international studies. Risk of MDD onset was found to vary with age as expected from earlier studies using interviewer-based assessments. Limited evidence was found to show that the distribution of first onset MDD episodes were compressed during the immediate pre-assessment period. Results were also consistent with previous evidence demonstrating the raised risk of MDD among women and of the decline in gender differences with advancing age. CONCLUSIONS: These results suggest that estimates of putative MDD diagnostic status, derived through the HLEQ, and of associated demographic risk are similar to those derived by more intensive and costly assessment methods. Implications for the future study of MDD both as an outcome and as a risk factor for chronic disease are discussed.

Aged↗

PubMed1999

EPIC-Germany--A source for studies into diet and risk of chronic diseases. European Investigation into Cancer and Nutrition.

The 'European Investigation into Cancer and Nutrition (EPIC)' represents one of the main scientific activities of the EU program 'Europe against Cancer' and is a large-scale cohort study on diet and chronic diseases, especially cancer, with approximately 475,000 study participants. The German contribution amounted to 53,000 study participants recruited between 1994 and 1998. The study instruments of the baseline examination included self-administered questionnaires for optical reading, PC-guided interviews, and physical examinations. These instruments covered different aspects of lifestyle, with a particular focus on diet. In addition, about 95% of the participants provided 30 ml of blood. The blood was stored in liquid nitrogen for further use, preferentially in nested case-control studies. All interviews and examinations were conducted by trained interviewers in examination centers established for this study in local health offices. Every 2 years, a follow-up questionnaire is mailed to the study participants. The follow-up questionnaires will be used as the major source of outcome information and to update exposure information. The self-reported diseases are verified by medical data. In the future, record linkage with local cancer registries will help to support the identification and collection of incident cancer cases. Only an outline of hypotheses was formulated at the very beginning of EPIC in 1992. In the future, each etiological study will be based on detailed research hypotheses according to the existing knowledge and identified research gaps. These studies will be conducted on cancer at the international level and on non-cancer diseases at the national or local level.

Adult↗

PubMed1999

Recruitment procedures of EPIC-Germany. European Investigation into Cancer and Nutrition.

EPIC is among the largest cohort studies, with approximately 475,000 study participants, on the etiological influence of diet and chronic diseases. During a 4-year recruitment period, two German EPIC centers, located in Heidelberg and Potsdam, aimed to recruit a total of 60,000 study participants from the local populations. The recruitment process was based on addresses from general population registries and started 4-5 weeks in advance with an initial invitation by mail to the basic examination for this study. Subjects not responding within 2 weeks were reminded. In Potsdam, this was done by mail and telephone, and in Heidelberg by telephone. During the recruitment phase, from 1994 to 1998, 53,162 subjects in total were examined for the cohort studies in Heidelberg (n = 25,546) and Potsdam (n = 27,616). The participation rate, compared to the invited number of subjects, was 22.7% in Potsdam and 38.3% in Heidelberg, with a considerable variation by municipality and gender. A comparison with data from the National Health Survey 1991/1992 revealed that the cohort populations were of higher socio-economic status and were healthier than the source population. We concluded that the selective participation would help to ensure high maintenance of the cohort during active follow-up. Selective participation does not harm etiological conclusions because disease associations are derived internally as relative risk. The relative risk estimates can be used to calculate population-attributable risk and preventable proportion, based on exposure prevalence derived by surveys and other studies.

Cohort Studies↗

PubMed1995

Bleeding complications with the chimeric antibody to platelet glycoprotein IIb/IIIa integrin in patients undergoing percutaneous coronary intervention. EPIC Investigators.

BACKGROUND: The potential for novel antiplatelet and antithrombin agents to contribute to periprocedural bleeding complications of percutaneous coronary revascularization is poorly defined. In the Evaluation of c7E3 Fab in Preventing Ischemic Complications of High-Risk Angioplasty (EPIC) trial, the periprocedural use of aspirin, heparin, and a chimeric antibody to the platelet glycoprotein IIb/IIIa integrin c7E3 Fab in 2099 patients significantly reduced postprocedural ischemic complications and 6-month clinical restenosis but was associated with increased procedural bleeding complications. We review these complications and describe clinical and procedural variables associated with increased bleeding complications in the EPIC trial. METHODS AND RESULTS: Patients with high-risk clinical or lesion morphological characteristics were randomized to receive placebo bolus plus placebo infusion, c7E3 Fab bolus plus placebo infusion, or c7E3 Fab bolus plus c7E3 Fab infusion. Patients received periprocedural aspirin and intravenous heparin continued for a minimum of 12 hours after the procedure. Outcomes reflecting bleeding complications were measured: transfusions, decreased hemoglobin, and an index including both parameters. Major bleeding complications unrelated to bypass surgery occurred in 3.3%, 8.6%, and 10.6%, and blood product transfusions were used in 7.5%, 14.0%, and 16.8% of patients treated with placebo, bolus c7E3 Fab, and bolus plus infusion c7E3 Fab, respectively (both P < .001). Most major bleeding complications occurred at the femoral access site, regardless of treatment. Intracranial hemorrhage (0.3%) and death (0.09%) attributable to major bleeding complications were rare. Multivariable regression analyses identified several variables significantly and independently related to major bleeding complications or greater blood loss, including greater age, female sex, lower weight, c7E3 Fab therapy, and duration and complexity of the index procedure. Major bleeding complications and blood loss in patients receiving bolus plus infusion were not significantly greater than in those receiving bolus alone (P = .38 and P = .14, respectively). CONCLUSIONS: Bleeding complications unrelated to bypass surgery were two to three times more frequent in patients receiving c7E3 Fab than in those receiving placebo, but most were transient and well tolerated. Risk-factor analysis and modification of concomitant antithrombotic and antiplatelet treatment strategies may aid in reducing bleeding complications and enhancing clinical benefit in patients receiving c7E3 Fab during percutaneous coronary revascularization.

Aged↗

PubMed1996

Economic assessment of platelet glycoprotein IIb/IIIa inhibition for prevention of ischemic complications of high-risk coronary angioplasty. EPIC Investigators.

BACKGROUND: In the EPIC trial, c7E3 Fab, an antiplatelet IIb/ IIIa receptor antibody, reduced 30-day ischemic end points after high-risk coronary angioplasty by 35% and 6-month ischemic events by 23% but increased in-hospital bleeding episodes. METHODS AND RESULTS: Of the 2099 patients randomized in EPIC, data were collected on 2038 (97%) for prospective hospital cost and major resources. Physician fees were estimated from the Medicare Fee Schedule. Regression analysis was used to examine the economic tradeoff between reduced ischemic events and increased major bleeding during the initial hospitalization. A potential cost savings of $622 per patient during the initial hospitalization from reduced acute ischemic events with c7E3 Fab was offset by an equivalent rise ($521) in costs as the result of an increase in bleeding episodes. Baseline medical costs for the bolus and infusion c7E3 Fab arm averaged $13,577 (exclusive of drug cost) compared with $13,434 for placebo (P = .42). During the 6-month follow-up, c7E3 Fab decreased repeat hospitalization rates by 23% (P = .004) and repeat revascularization by 22% (P = .04), producing a mean $1270 savings per patient (exclusive of drug cost) (P = .018). With a cost of $1407 for the bolus and infusion c7E3 Fab regimen, the cumulative net 6-month cost to switch from standard care to routine c7E3 Fab averaged $293 per patient. CONCLUSIONS: In high-risk coronary angioplasty, aggressive platelet inhibition with c7E3 Fab, by significantly reducing ischemic events and repeat revascularization, recoups most of the cost of therapy and has the potential to pay for itself.

Abciximab↗

PubMedDate not supplied

Correlates of age at natural menopause in the cohorts of EPIC-Italy.

A large number of studies have investigated the factors correlated to age at natural menopause in several populations. However, information on genetics and life-style factors influencing the age of onset of menopause in different populations is of current scientific interest. Specifically, for Italian women there are no large population-based data. The EPIC-Italy collaboration is a source of data of this kind; moreover, the geographical distribution of the cohorts (recruited in northern, central and southern Italy) is an added value as regards the scientific interest of these data. A number of biological and life-style-related factors have been analyzed to evaluate their association to the age at natural menopause in 14,454 menopausal women of the EPIC-Italy collaboration. As regards life-style and environmental factors, the main results are: a) women living in different areas of the country have different ages of onset of natural menopause; b) educational level is significantly associated to this age and may explain part of the between-center difference; c) cigarette smoking appears as a major correlate and probably determinant of the age at natural menopause across all the Italian cohorts; d) alcohol consumption does not have any relationship with the age at natural menopause; e) the use of oral contraceptives may influence age at natural menopause. As regards biological factors, short cycles and low parity have been found associated with earlier menopause. Overall, the results concerning menstrual cycles, parity, and cigarette smoking are consistent with the hypothesis that the number of oocytes in the ovary is pre-determined and any acceleration or impairment of the ovarian function leads to reduce the duration of the reproductive life.

Aging↗