bluuebunny/crossref_metadata_2025 huggingface dataset:
Height, age at menarche, body weight and body mass index in life-long vegetarians
Authors: Rosell Magdalena , Appleby Paul , Key Tim
Published: October 2005

Objective

We investigated whether life-long adherence to a vegetarian diet is associated with adult height, age at menarche, adult body weight and body mass index (BMI), used as indicators of growth, development and obesity, in a large sample of adults.

Design

This was a cross-sectional study. Anthropometric data and information on age, ethnicity, education, age at menarche and age at becoming a vegetarian were obtained through a questionnaire. Self-reported height and weight were calibrated using predictive equations derived from a previous validation study.

Setting

United Kingdom.

Subjects

The study includes 45 962 British men and women aged ≥ 20 years of whom 16 083 were vegetarians (not eating fish or meat).

Results

In men and women, there were no significant differences in height, weight or BMI between life-long vegetarians (n= 125 (men) andn= 265 (women)) and people who became vegetarian at age ≥ 20 years (n= 3122 (men) andn= 8137 (women)). Nor was there a significant difference in age at menarche between life-long vegetarian women and women who became vegetarian at age ≥ 20 years.

Conclusion

This study suggests that, compared with people who become vegetarian when adult, life-long vegetarians do not differ in adult height, weight, BMI or age at menarche in women.
Fruit and vegetable intakes in a sample of pre-school children participating in the ‘Five for All’ project in Bradford
Authors: Cockroft JE , Durkin M , Masding C , Cade JE
Published: October 2005

Background

Longitudinal research has shown that eating fruit and vegetables during childhood has a positive impact on long-term health outcome from heart disease and asthma. However, recommendations for fruit and vegetable intakes in pre-school children are not as explicit as those for adults and few data exist on actual intakes of fruit and vegetables in this particular age group.

Aims

To describe fruit and vegetable intakes in the daily diets of a sample of pre-school children in Bradford, West Yorkshire, and to compare the findings with existing national UK data.

Subjects

Pre-school children aged 3 and 4 years (n= 207). All subjects attended nurseries in the Airedale and Bradford South and West regions at the time of the study.

Design

Dietary data were collected using the pre-validated CADET (Child and Diet Evaluation Tool) diary. All children were also seen individually in order to assess their awareness and preference for a range of fruit and vegetables.

Results

Intakes of fruit and vegetables in this sample of pre-school children were below recommended levels. Only 16% of children in this sample were successfully eating fruit and vegetables on five occasions a day and conversely 14% ate no fruit and vegetables at all. Vegetable intakes were far lower than fruit intakes with 39% of the sample consuming no vegetables. There were statistically significant differences in median fruit and vegetable intakes between children with different demographic and lifestyle variables, such as which nursery they attended and what the highest educational qualification in the household was. Children's awareness of and preferences for different fruit and vegetables significantly affected their median intakes of fruit and vegetables.

Conclusion

Fruit and vegetable intakes in this sample of pre-school children were far lower than the recommended levels of 5 portions a day. A greater diversity of intakes should be encouraged and these data suggest that this may be attained by increasing children's awareness by exposing them to a wider range of fruit and vegetables.
Environmental and psychosocial correlates of physical activity in Portuguese and Belgian adults
Authors: Bourdeaudhuij Ilse De , Teixeira Pedro J , Cardon Greet , Deforche Benedicte
Published: October 2005

Objectives

To investigate differences in reported physical activity levels and in perceived environmental and psychosocial correlates of activity between Portuguese and Belgian adults; and to analyse the relative contribution of environmental and psychosocial variables in explaining physical activity within different contexts in Portugal and Belgium.

Design

Cross-sectional study.

Setting

One city in Portugal (Oeiras) and one in Belgium (Ghent).

Subjects

In total 526 participants, 247 from Portugal and 279 from Belgium, completed the long International Physical Activity Questionnaire and a validated questionnaire on environmental and psychosocial correlates.

Results

For the sum of all activities of at least moderate intensity, a significantly higher mean level of activity was found in Belgian adults (P < 0.001). However, comparable percentages of the Belgian (38%) and Portuguese (42%) samples did not meet the recommendation of 30 min per day. The variance explained by environmental factors was lower (1% to 8%) than by psychosocial factors (maximum 42%). Regression analyses showed activity-specific relations with environmental variables which were analogous in both countries. Walking/cycling for transportation and walking for recreation were related to social support from family and/or friends and to walkability and walking facilities in the neighbourhood. Recreational physical activity was mainly determined by social support, self-efficacy, and perceived benefits and barriers.

Conclusions

Activity campaigns addressing psychosocial determinants are needed to encourage leisure-time activity, while a combination of neighbourhood design changes and encouragement of social support in walking is warranted to increase walking in different contexts.
Past food habit change is related to obesity, lifestyle and socio-economic factors in the Malmo Diet and Cancer Cohort
Authors: Sonestedt Emily , Wirfält Elisabet , Gullberg Bo , Berglund Göran
Published: October 2005

Objectives

To examine if obesity status and socio-economic and lifestyle factors are associated with self-reported past food habit change, and also whether the level of obesity depends on the reason for change.

Design

Cross-sectional analysis within the Malmo Diet and Cancer (MDC) study using data from the baseline examination and the extensive socio-economic and lifestyle questionnaire including questions of past food habit change. The risk of having changed food habits in the past was examined using logistic regression. Mean differences in obesity status across categories of reasons for past food habit change were examined using analysis of variance.

Setting

Malmö, the third largest city in Sweden.

Subjects

A sub-sample (15 282 women and 9867 men) from the MDC cohort recruited from 1992 to 1996.

Results

Individuals with body mass index (BMI) >30 kg m−2 had an increased risk of having reported past food habit change compared with individuals with BMI <25 kg m−2 (odds ratio (OR) = 1.63, 95% confidence interval (CI) = 1.48–1.83 for women; OR = 1.53, 95% CI = 1.32–1.76 for men). The highest level of obesity was observed among individuals who had changed their diet due to reasons related to the metabolic syndrome. Changers were more likely to be highly educated and to live alone, be retired, ex-smokers and non-drinkers at baseline.

Conclusions

Because past food habit change is related to obesity and other lifestyle and socio-economic factors, a complex confounding situation may exist that could seriously influence observed relationships between diet and disease. Studies need to collect information on past food habit change and take this information into account in the analysis and when interpreting study outcomes.
Nutrition security, livelihoods and HIV/AIDS: implications for research among farm worker households in South Africa
Authors: Lemke S
Published: October 2005

Objective

Previous research on the health transition and nutrition security in black South African households revealed the need for further research among farm workers who belong to the poorest population categories. This article gives an overview of the link between nutrition security, livelihoods and HIV/AIDS in South Africa, drawing conclusions for research among farm worker households.

Design and setting: A literature review, observations on farms and interviews with farmers and key informants were carried out in 2003 and 2004. Peer examination was done with South African and German researchers from the natural and social sciences.

Results

Farm workers face poverty and nutrition insecurity and continue to be a tragically underserved population group, also in terms of research. There is furthermore a lack of in-depth research on underlying causes for nutrition security in South Africa and on the link with livelihoods, poverty and HIV/AIDS. Micro-social qualitative research from the household and gender perspective is required, as valid data on households, their internal dynamics and therefore the reflection of social realities are missing. A multidisciplinary research approach based on a new conceptual framework was developed to address the situation of farm worker households.

Conclusion

The outlined research contributes to existing programmes on farms in the North West Province, with the findings being valid also for other parts of southern Africa facing poverty, nutrition insecurity and HIV/AIDS.
Dietary intakes and health-related behaviours of Korean American women born in the USA and Korea: The Multiethnic Cohort Study
Authors: Park Song-Yi , Murphy Suzanne P , Sharma Sangita , Kolonel Laurence N
Published: October 2005

Objective

This study assessed and compared heath-related behaviours and nutrient and food group intakes between US-born and Korea-born Korean American women.

Design and subjects

Cross-sectional analyses were performed for ethnic Koreans who participated in the Multiethnic Cohort Study in Hawaii and Los Angeles in 1993–1996. The sample included 492 Korean American women aged 45–75 years who were born in the USA (n= 274) or Korea (n= 218). Participants were recruited using driver's license files as a primary sampling source and completed a self-administered questionnaire, including a quantitative food frequency section.

Results

The proportion overweight or obese was 31.4% in US-born and 9.4% in Korea-born women. US-born women had higher intakes of total fat and fat as a percentage of energy, and lower intakes of sodium, vitamin C, β-carotene and carbohydrate as a percentage of energy, than Korea-born women. Comparing intakes of food group servings from the Food Guide Pyramid, US-born women reported more whole grains, red meat and nuts, and less soy products, than did Korea-born women. US-born women also consumed fewer vegetables and fruit than those born in Korea. Few women in either group reported intakes that met the recommendations for dairy foods. Intake of discretionary fat from the Pyramid tip was higher in US-born than in Korea-born women.

Conclusions

These findings indicate that the acculturation of Korean immigrants affects dietary intakes in ways that may alter risks of several chronic diseases. Further studies will be necessary to examine the effects of dietary acculturation on disease patterns.
Glycaemic index, glycaemic load and risk of endometrial cancer: a prospective cohort study
Authors: Silvera Stephanie AN , Rohan Thomas E , Jain Meera , Terry Paul D , Howe Geoffrey R , Miller Anthony B
Published: October 2005

Objective

High-glycaemic-load diets may increase endometrial cancer risk by increasing circulating insulin levels and, as a consequence, circulating oestrogen levels. Given the paucity of epidemiological data regarding the relationship between dietary glycaemic index and glycaemic load and endometrial cancer risk, we sought to examine these associations using data from a prospective cohort study.

Design, setting and subjects

We examined the association between dietary glycaemic load and endometrial cancer risk in a cohort of 49 613 Canadian women aged between 40 and 59 years at baseline who completed self-administered food-frequency questionnaires between 1982 and 1985. Linkages to national mortality and cancer databases yielded data on deaths and cancer incidence, with follow-up ending between 1998 and 2000.

Results

During a mean of 16.4 years of follow-up, we observed 426 incident cases of endometrial cancer. Hazard ratios for the highest versus the lowest quartile level of overall glycaemic index and glycaemic load were 1.47 (95% confidence interval (CI) = 0.90–2.41;Pfor trend = 0.14) and 1.36 (95% CI = 1.01–1.84;Pfor trend = 0.21), respectively. No association was observed between total carbohydrate or total sugar consumption and endometrial cancer risk. Among obese women (body mass index > 30 kg m−2) the hazard ratio for the highest versus the lowest quartile level of glycaemic load was 1.88 (95% CI = 1.08–3.29;Pfor trend = 0.54) and there was a 55% increased risk for the highest versus the lowest quartile level of glycaemic load among premenopausal women. There was also evidence to support a positive association between glycaemic load and endometrial cancer risk among postmenopausal women who had used hormone replacement therapy.

Conclusions

Our data suggest that diets with high glycaemic index or high glycaemic load may be associated with endometrial cancer risk overall, and particularly among obese women, premenopausal women and postmenopausal women who use hormone replacement therapy.
Efficacy of a community-based dietary intervention to enhance micronutrient adequacy of high-phytate maize-based diets of rural Malawian children
Authors: Yeudall Fiona , Gibson Rosalind S , Cullinan Timothy R , Mtimuni Beatrice
Published: October 2005

Objective

To evaluate the efficacy of a community-based dietary intervention to reduce risk of micronutrient inadequacies in high-phytate maize-based Malawian diets.

Design

Quasi-experimental post-test design with a non-equivalent control group.

Setting

Four villages in Mangochi District, Southern Malawi.

Participants

Households with children aged 3–7 years in two intervention (n = 200) and two control (n = 81) villages participated in a 6-month intervention employing dietary diversification, changes in food selection patterns, and modifications to food processing to reduce the phytate content of maize-based diets. Baseline comparability between the groups was confirmed via assessment of sociodemographic characteristics, anthropometry, knowledge and practices, morbidity, haemoglobin and hair zinc. After 12 months, knowledge and practices and dietary intakes were assessed by interactive 24-hour recalls, one during the food plenty and a second during the food shortage season. Nutrient adequacy for the two groups was compared via dietary quality indicators and predicted prevalence of inadequate intakes using the probability approach.

Results

Intervention children had diets that were significantly more diverse and of a higher quality than those of controls. Median daily intakes of protein, calcium, zinc (total and available), haem iron, vitamin B12 and animal foods (grams; % of total energy) were higher (P<0.05) whereas phytate intakes, phytate/zinc and phytate/iron molar ratios were lower (P<0.01) in the intervention group; some spread of knowledge and practices to controls occurred.

Conclusions

Our community-based dietary strategies reduced the predicted prevalence of inadequate intakes of protein, calcium, zinc and vitamin B12, but not iron, in children from Malawian households with very limited resources.
Maternal micronutrient status and decreased growth of Zambian infants born during and after the maize price increases resulting from the southern African drought of 2001–2002
Authors: Gitau R , Makasa M , Kasonka L , Sinkala M , Chintu C , Tomkins A , Filteau S
Published: October 2005

Objective

To investigate the effects on maternal micronutrient status and infant growth of the increased maize prices that resulted from the southern African drought of 2001–2002.

Design

Longitudinal cohort study.

Setting

A maternal and child health clinic in Lusaka, Zambia.

Subjects

Maternal and infant health and nutrition data and maternal plasma were being collected for a study of breast-feeding and postpartum health. Samples and data were analysed according to whether they were collected before (June to December 2001), during (January 2002 to April 2003) or after (May 2003 to January 2004) the period of increased maize price. Season and maternal HIV status were controlled for in analyses.

Results

Maize price increases were associated with decreased maternal plasma vitamin A during pregnancy (P= 0.028) and vitamin E postpartum (P= 0.042), with the lowest values among samples collected after May 2003 (vitamin A: 0.96 μmol l−1, 95% confidence interval (CI) 0.84–1.09,n= 38; vitamin E: 30.8 μmol mmol−1triglycerides, 95% CI 27.2–34.8,n= 64) compared with before January 2002 (vitamin A: 1.03 μmol l−1, 95% CI 0.93–1.12,n= 104; vitamin E: 38.9 μmol mmol−1triglycerides, 95% CI 34.5–43.8,n= 47). There were no significant effects of sampling date on maternal weight, haemoglobin or acute-phase proteins and only marginal effects on infant weight. Infant length at 6 and 16 weeks of age decreased progressively throughout the study (P-values for time of data collection were 0.51 at birth, 0.051 at 6 weeks and 0.026 at 16 weeks).

Conclusions

The results show modest effects of the maize price increases on maternal micronutrient status. The most serious consequence of the price increases is likely to be the increased stunting among infants whose mothers experienced high maize prices while pregnant. During periods of food shortages it might be advisable to provide micronutrient supplements even to those who are less food-insecure.
Individual Reference Intervals of Hematological and Serum Biochemical Parameters in Cynomolgus Monkeys
Authors: Koga Tadashi , Kanefuji Koji , Nakama Kazuhiro
Published: October 2005

Cynomolgus monkeys, one of a number of primates phylogenetically close to humans, are commonly used in animal studies. The purpose of this study was to assess biological variations in hematological and serum biochemical parameters in cynomolgus monkeys. Summary statistics and reference intervals were calculated using data from 95 male and 95 female Chinese-bred cynomolgus monkeys aged 3 to 7 years showing no abnormalities during the breeding period. Within- and between-animal variations were estimated using a random-effect analysis of variance (ANOVA), then, a simple method that applies prior information was proposed to estimate individual reference intervals. Parameters including MCV, MCH, PT, ALP, total cholesterol, and creatinine appeared to show a large between-animal variation; thus, it is considered that individual reference intervals for these parameters would be relatively small in comparison with overall reference intervals.
Evaluation of the Carcinogenic Potential of Clofibrate in the FVB/Tg.AC Mouse After Dermal Application—Part II
Authors: Torrey Carla E. , Wall Henry G. , Campbell James A. , Kwanyuen Puntipa , Hoivik Debie J. , Miller Richard T. , Allen Jane S. , Jayo Manuel J. , Selinger Krzysztof , Santostefano Michael J.
Published: October 2005

This study was conducted as part of the International Life Sciences Institute (ILSI) Alternatives to Carcinogenicity Testing program and evaluated the carcinogenic potential of clofibrate, a nongenotoxic, peroxisome proliferator-activated receptor (PPAR) α agonist following dermal application to transgenic Tg.AC and nontransgenic FVB mice for a minimum of 26 weeks. Clofibrate doses of 12, 28, or 36 mg/200 μl/day were used. Positive controls for papilloma formation were benzene (174.8 mg/200 μl), and 12- o-tetradecanoylphorbol-13-acetate (TPA [0.00250 mg/200 μl]). Clofibrate was tolerated at doses up to 36 mg/200 μl. In Tg.AC mice, clofibrate produced a dose-related increase in the incidence of mice with cutaneous papillomas; and dose-related decreases in mean time to first tumor, mean multiplicity of tumors per mouse, and mean weeks to maximal yield, as well as numerous nonneoplastic microscopic lesions in the liver, kidney, spleen, and skin. Benzene and TPA induced both neoplastic and/or non-neoplastic proliferative lesions in Tg.AC mice. Clofibrate did not increase the incidence or multiplicity of papillomas, or any other tumors in FVB mice. These data show that the Tg.AC dermal model has increased sensitivity in detecting skin papillomas caused by the nongenotoxic rodent carcinogen, clofibrate, compared to wild type FVB mice, at systemic exposures that are 3× higher than the systemic exposure observed in humans taking clofibrate (AUC = 1100 μg ·h/ml) at the recommended maximum therapeutic dose of 500 mg. In addition, this study supports the proposed concept that Tg.AC model may detect compounds with nongenotoxic carcinogenic potential in a shorter timeframe than conventional mouse carcinogenicity bioassays.
Concomitant Administration of Bevacizumab, Irinotecan, 5-Fluorouracil, and Leucovorin: Nonclinical Safety and Pharmacokinetics
Authors: Gaudreault Jacques , Shiu Vanessa , Bricarello Ann , Christian Brian J. , Zuch Christina L. , Mounho Barbara
Published: October 2005

Bevacizumab (Avastin) is a humanized monoclonal antibody against vascular endothelial growth factor approved for use in combination with 5-fluorouracil (5-FU)-based chemotherapy for first-line treatment of metastatic colorectal cancer. The Saltz regimen (irinotecan/5-FU/leucovorin [LV]) is a first-line treatment for this indication. The objective of this study was to evaluate the safety of bevacizumab when administered concomitantly with the Saltz regimen to cynomolgus monkeys, and to determine if the pharmacokinetics of bevacizumab, irinotecan, SN38 (the active metabolite of irinotecan), or 5-FU were affected by combined administration. Male cynomolgus monkeys were intravenously administered the Saltz regimen (125 mg/m2irinotecan, 500 mg/m25-FU, 20 mg/m2LV) alone ( n = 4) or concomitantly with 10 mg/kg bevacizumab ( n = 5) on days 1 and 8. All animals survived to euthanasia on day 15. Adverse effects associated with the Saltz regimen included diarrhea and neutropenia. Macroscopically, two animals from each group had small thymus glands that correlated microscopically with lymphoid depletion. Myeloid hypoplasia and/or erythroid hyperplasia was observed in the sternal bone marrow of most animals. These effects were considered to be associated with the Saltz regimen; concomitant bevacizumab administration did not alter the severity of these findings. Irinotecan and 5-FU were observed to be rapidly eliminated ( t1/2= 1 h and 0.5 h, respectively). Although the number of animals in each group was small and no statistical comparison between groups was performed, bevacizumab did not affect the disposition of either agent. These results indicate that bevacizumab can be safely administered in combination with the Saltz regimen without pharmacokinetic interaction.
Effect of Dietary Fat on Selected Parameters of Toxicity Following 1- or 3-Month Exposure of Rats to Toluidine Isomers
Authors: Jodynis-Liebert Jadwiga , Bennasir Hassen A. H.
Published: October 2005

The aim of the study was to investigate the effect of the dietary fat on selected parameters of toluidines toxicity in rats during sub-chronic exposure. Three isomers of toluidine ( ortho, meta, and para) were administered to rats in the diet for 1 and 3 months at levels 40, 80, 160 mg/kg/day in two kinds of diet containing either 4% or 14% fat. All doses of toluidine isomers produced a 1.5- to 9.8-fold increase in methemoglobin (MetHb) level during both treatment periods. A distinct dose-response relationship was observed, especially for o- and m-toluidine; the effect was generally greater in rats fed high-fat diet. Reduced glutathione level in liver was increased in all treated groups, 1.5- to 5.1-fold, irrespective of the kind of diet. An increase in hepatic lipid peroxidation (thiobarbituric acid reactive substances; TBARS), 1.5- to 4.5-fold, was noticed in the majority of the treated groups. Generally, there was no consistent effect of diet except for p-toluidine where the level of hepatic TBARS was lower in rats fed high-fat diet. Blood urea nitrogen (BUN) level in animals treated with all doses of o- and m-toluidine was 1.3- to 5.0-fold higher in comparison with respective controls. No clear relationship between BUN level and the kind of diet was found. No effect of toluidines on the activity of serum aspartate aminotrans-ferase (AST) and sorbitol dehydrogenase (SDH) were observed. In the majority of groups treated for 30 and 90 days the amount of toluidines in 24-h urine was lower in rats fed high-fat diet. Final body weight gain in rats treated with o- and p-toluidine (80 and 160 mg/kg body weight [b.w.]) was lower as compared to controls. In summary the high-fat diet stimulated methemoglobin formation in rats treated with o- and m-toluidine and cause the decrease in the amount of toluidines in 24-h urine. The high content of fat did not affect consistently the other parameters tested.
Evaluation of the Carcinogenic Potential of Clofibrate in the rasH2 Mouse
Authors: Nesfield Sarah R. , Clarke Christopher J. , Hoivik Debie J. , Miller Richard T. , Allen Jane S. , Selinger Krzysztof , Santostefano Michael J.
Published: October 2005

The purpose of the study was to support of the International Life Sciences Institute (ILSI) alternative carcinogenicity models initiative to evaluate the carcinogenic potential of the nongenotoxic carcinogen, clofibrate, a peroxisome proliferator-activated receptor (PPAR) α agonist, following oral administration to rasH2 mice. Peroxisome proliferators are one of the most widely studied of the nongenotoxic carcinogens and have diverse industrial and therapeutic uses (Gonzalez et al. J. Nat. Cancer Inst. 90: 1702–1709, 1998); however, the nongenotoxic mechanism of carcinogenicity is currently unknown. Male mice were administered doses of clofibrate at 50, 100, or 200 mg/kg/day and female mice were administered doses of 50, 150, or 250 mg/kg/day by oral gavage at 10 ml/kg for 27 weeks. In addition, rasH2 male and female mice were treated with N-nitroso- N-methylurea (NMU). Nontransgenic male and female mice were treated with 200 and 250 mg/kg/day, respectively, of clofibrate. The NMU-treated mice were given a single intraperitoneal dose of 75 mg/kg, which was followed by a 90-day observation period; all others were sacrificed after 6 months of daily dosing. Hepatocellular neoplasms were observed in clofibrate-treated rasH2 male mice after 6 months of treatment but not in nontransgenic males or females. Clofibrate treatment (250 mg/kg/day) of female rasH2 mice was associated with a slight increase in the incidence of various neoplasms (harderian gland, lungs, skin, spleen, tail, thymus, and uterus) compared with untreated transgenic mice and with similarly treated nontransgenic mice. Non-neoplastic changes were found in the liver of transgenic and nontransgenic mice of both sexes and in the kidneys of male mice. NMU produced findings are consistent with previous studies. The data suggest that the rasH2 mice are a good model for testing epigenetic carcinogens in a shorter timeframe than conventional mouse carcinogenicity bioassays.
Studies Evaluating the Utility of N-Methyl-N-Nitrosourea as a Positive Control in Carcinogenicity Studies in the p53+/– Mouse
Authors: Hoivik Debie J. , Allen Jane S. , Wall Henry G. , Nold James B. , Miller Richard T. , Santostefano Michael J.
Published: October 2005

Studies conducted under the auspices of International Life Sciences Institute (ILSI) have suggested that an alternative mouse carcinogenicity study may be substituted for the traditional 2-year mouse bioassay typically conducted to support the development of drug candidates. The purpose of this study was to characterize the carcinogenic potential of N-methyl- N-nitrosourea (MNU), a DNA alkylating agent, in p53+ /– knockout mice to determine its suitability as a positive control agent in an alternative carcinogenicity model. p53+ /– knockout mice were administered a single oral dose of 90 mg/kg and maintained for up to 13 weeks prior to evaluation of neoplasms. Treatment was generally well tolerated; however, 4 of 30 mice died between the days of 75 and 92 due to neoplasms. MNU-related macroscopic observations included enlargement of the thymus, spleen, mandibular and mesenteric lymph nodes; and pale liver, heart, kidney, and bone marrow, which correlated with the diagnosis of lymphoma of the hematopoietic system, noted in the thymus of all affected animals and in the spleen, liver, lungs, and kidneys of some animals. Other treatment-related single neoplasms included a squamous-cell carcinoma in the nonglandular stomach and leiomyosarcoma in the glandular stomach. Non-neoplastic proliferative lesions included acanthosis and hyperkeratosis in the nonglandular stomach, focal papillary hyperplasia of the nonglandular stomach, glandular hyperplasia of the stomach, and adenomatous hyperplasia of the duodenum or ileum. The increased incidence of neoplastic and proliferative changes in MNU-treated mice suggests MNU could serve as a positive control in alternative carcinogenicity studies conducted in p53+ /– knockout mice.
Evaluation of the Carcinogenic Potential of Clofibrate in the Neonatal Mouse
Authors: Nesfield Sarah R. , Williams Thomas C. , Hoivik Debie J. , Miller Richard T. , Allen Jane S. , Selinger Krzysztof , Rickert Douglas , Santostefano Michael J.
Published: October 2005

This study was conducted in support of the International Life Sciences Institute (ILSI) alternative carcinogenicity models initiative to evaluate the carcinogenic potential of clofibrate, a nongenotoxic peroxisome proliferator-activated receptor (PPAR) α agonist, following oral administration to neonatal mice. Male and female neonatal CD-1 mice were dosed with clofibrate at doses of 100, 250, and 500 mg/kg or with the positive control, diethyl-nitrosamine (DEN), at 2 mg/kg by oral gavage on days 9 and 16 post birth and observed for approximately 1 year for the development of tumors. Plasma levels of clofibric acid after the second administration increased with dose, but were not dose proportional. Clofibrate administered by gavage on litter days 9 and 16 to neonatal mice at doses of 100, 250, or 500 mg/kg did not produce a carcinogenic effect. The positive control DEN did produce tumors in the liver and lung (single and multiple adenomas and carcinomas) and harderian gland (adenoma) of both sexes. Non-neoplastic lesions related to DEN treatment were confined to myocardial degeneration/fibrosis and testicular interstitial hyperplasia in males, and to glomerulonephrosis and gastritis in both sexes.
Use of the platelet function analyser (PFA‐100®) to quantify the effect of low dose aspirin in patients with ischaemic heart disease
Authors: Coakley M. , Self R. , Marchant W. , Mackie I. , Mallett S. V. , Mythen M.
Published: October 2005

Continuing aspirin up until surgery in cardiac surgical patients may increase peri‐operative blood loss. It is possible that there is a subset of patients particularly sensitive to aspirin. The platelet function analyser (PFA‐100®) can demonstrate the antiplatelet effect of aspirin. This study was designed to assess the effect of daily 75 mg aspirin on platelet function, as measured by the PFA‐100®, in 92 patients with ischaemic heart disease. Patients were classified into three groups according to their PFA‐100® results; aspirin hyper‐responders (16%), aspirin normal responders (33%) and aspirin non‐responders (51%). The PFA‐100® has potential as a screening tool to identify patients who are either hyper‐responsive or resistant to aspirin. Pre‐operative PFA‐100® screening to isolate aspirin hyper‐responders could enable the vast majority of patients to continue with aspirin therapy pre‐operatively, avoiding the risks of stopping treatment.
A randomised comparison of the Portex Softseal™ laryngeal mask airway with the LMA‐Unique™ during anaesthesia
Authors: Cook T. M. , Trümpelmann P. , Beringer R. , Stedeford J.
Published: October 2005

We have compared the performance of the single use laryngeal airway devices Softseal™ and LMA‐Unique™ in a randomised comparative trial in anaesthetised healthy patients who did not receive neuromuscular blockade. Primary outcome was success of airway placement. Secondary outcomes included manipulations and complications during use, ease of insertion, airway and fibreoptic assessment of airway positioning, and complications postoperatively. We planned to study 300 patients but interim analysis demonstrated the study should be stopped after 100 patients. During insertion the Softseal™ required more attempts for successful insertion (p = 0.041), more manipulations (p < 0.0001) and caused more complications (p = 0.048). Failure of placement occurred in five cases with the Softseal™ and none with the LMA‐Unique™ (p = n/s). Two Softseal™ needed to be removed during maintenance because of airway obstruction, giving an overall failure rate of seven (p = 0.013). Serial tests of positioning favoured the LMA‐Unique™ (p = 0.012). Ventilation was more successful in the LMA‐Unique™ group but the difference was not significant (p = 0.051). Seal pressure was higher with the Softseal™ (26.5 vs. 20.5 cmH2O, p = 0.005). Fibreoptic view via the devices was not statistically significantly different. During maintenance of anaesthesia more complications arose with the Softseal™ (p = 0.03). Anaesthetist ratings of ease of insertion and overall usefulness favoured the LMA‐Unique™ (p < 0.0001 and p = 0.024, respectively). After anaesthesia, sore throat occurred more frequently and was more severe in those patients anaesthetised with a Softseal™ both in recovery (p = 0.015) and at 24 h (p = 0.012). We conclude that the Softseal™ performs less well and causes more complications than the LMA‐Unique™.
Histamine release during adult cardiopulmonary bypass
Authors: Fayaz K. M. , Pugh S. , Balachandran S. , Sudheer P. S. , Hall J. E.
Published: October 2005

Histamine, an inflammatory mediator in its own right, may also be a marker for a more widespread systemic inflammatory process. In this study we have examined variations in plasma histamine concentrations produced during the course of cardiac surgery involving cardiopulmonary bypass, the relationship between these variations and intra‐operative events. By assays of serum tryptase and CD‐63 expression we have also attempted to identify the source of histamine. Histamine concentrations that were significantly raised from baseline level were demonstrated. These were elevated from the time of aortic cross‐clamping and continued to be raised for 24 h postoperatively (p < 0.00625). This was associated with an increase in CD‐63 expression (p < 0.025) (but not an increase in tryptase concentration) following aortic cross‐clamping and protamine administration, suggesting that basophils are the source of histamine. 41% of patients had arrhythmias in the post bypass period. The rise in histamine levels was not related to the incidence of cardiac arrhythmias.
On spatial prediction of soil properties in the presence of a spatial trend: the empirical best linear unbiased predictor (E‐BLUP) with REML
Authors: Lark R. M. , Cullis B. R. , Welham S. J.
Published: October 2005

Geostatistical estimates of a soil property by kriging are equivalent to the best linear unbiased predictions (BLUPs). Universal kriging is BLUP with a fixed‐effect model that is some linear function of spatial co‐ordinates, or more generally a linear function of some other secondary predictor variable when it is called kriging with external drift. A problem in universal kriging is to find a spatial variance model for the random variation, since empirical variograms estimated from the data by method‐of‐moments will be affected by both the random variation and that variation represented by the fixed effects.

The geostatistical model of spatial variation is a special case of the linear mixed model where our data are modelled as the additive combination of fixed effects (e.g. the unknown mean, coefficients of a trend model), random effects (the spatially dependent random variation in the geostatistical context) and independent random error (nugget variation in geostatistics). Statisticians use residual maximum likelihood (REML) to estimate variance parameters, i.e. to obtain the variogram in a geostatistical context. REML estimates are consistent (they converge in probability to the parameters that are estimated) with less bias than both maximum likelihood estimates and method‐of‐moment estimates obtained from residuals of a fitted trend. If the estimate of the random effects variance model is inserted into the BLUP we have the empirical BLUP or E‐BLUP. Despite representing the state of the art for prediction from a linear mixed model in statistics, the REML–E‐BLUP has not been widely used in soil science, and in most studies reported in the soils literature the variogram is estimated with methods that are seriously biased if the fixed‐effect structure is more complex than just an unknown constant mean (ordinary kriging). In this paper we describe the REML–E‐BLUP and illustrate the method with some data on soil water content that exhibit a pronounced spatial trend.
ADP‐ribosylation of dinitrogenase reductase in Azospirillum brasilense is regulated by AmtB‐dependent membrane sequestration of DraG
Authors: Huergo Luciano F. , Souza Emanuel M. , Araujo Mariana S. , Pedrosa Fábio O. , Chubatsu Leda S. , Steffens Maria B. R. , Merrick Mike
Published: October 2005

Nitrogen fixation in some diazotrophic bacteria is regulated by mono‐ADP‐ribosylation of dinitrogenase reductase (NifH) that occurs in response to addition of ammonium to the extracellular medium. This process is mediated by dinitrogenase reductase ADP‐ribosyltransferase (DraT) and reversed by dinitrogenase reductase glycohydrolase (DraG), but the means by which the activities of these enzymes are regulated are unknown. We have investigated the role of the PII proteins (GlnB and GlnZ), the ammonia channel protein AmtB and the cellular localization of DraG in the regulation of the NifH‐modification process in Azospirillum brasilense. GlnB, GlnZ and DraG were all membrane‐associated after an ammonium shock, and both this membrane sequestration and ADP‐ribosylation of NifH were defective in an amtB mutant. We now propose a model in which membrane association of DraG after an ammonium shock creates a physical separation from its cytoplasmic substrate NifH thereby inhibiting ADP‐ribosyl‐removal. Our observations identify a novel role for an ammonia channel (Amt) protein in the regulation of bacterial nitrogen metabolism by mediating membrane sequestration of a protein other than a PII family member. They also suggest a model for control of ADP‐ribosylation that is likely to be applicable to all diazotrophs that exhibit such post‐translational regulation of nitrogenase.
Exploring the role of self‐management programmes in caring for people from culturally and linguistically diverse backgrounds in Melbourne, Australia
Authors: Walker Christine , Weeks Amanda , McAvoy Brian , Demetriou Elsa
Published: October 2005

Background  Chronic disease self‐management programmes are now an important adjunct to the treatment and care of Australians with chronic illnesses. Most programmes are delivered in English and cater for ‘Anglo’ views of health and illness. The Peer‐Led Self‐Management of Chronic Illness Project was funded by the National Health and Medical Research Council (NHMRC) to test the hypothesis that the Stanford University Chronic Disease Self‐Management Program would improve health outcomes for people from the Vietnamese, Greek, Chinese and Italian communities in Melbourne's north‐eastern suburbs.

Objective  To examine the extent to which the programme required modification so that the concepts associated with self‐management programmes have relevance to the health behaviours of people with chronic illness from the above communities.

Methods  Four focus groups facilitated in English, using interpreters.

Results  There was wide understanding of the concepts employed in self‐management programmes. Literacy problems emerged as the major obstacle to participating in unmodified programmes.

Conclusion  The conceptual aspects of the programme require less modification than originally predicted, but the programme requires sensitive modification so that it is accessible to people with low literacy levels.
Meeting the educational needs of people at risk of diabetes‐related amputation: a vignette study with patients and professionals
Authors: Johnson Maxine , Newton Peggy , Jiwa Moyez , Goyder Elizabeth
Published: October 2005

Objective  To investigate how patients and professionals view the role of advice in diabetes foot care, in order to inform educational practice.

Design  A qualitative study based upon one‐to‐one interviews using a vignette technique with patients and professionals.

Setting and participants  Interviews with 15 patients with diabetes‐related foot complications attending diabetes foot clinics, and 15 health professionals across two hospital sites and two primary care trusts.

Results  There were similarities between issues raised by patients and professionals, with differences in emphasis. An important factor was patient understanding and acceptance of the implications of diabetes from diagnosis. Many patients reported a lack of early understanding that may reflect inadequate provision or acceptance of advice. Development of positive relationships with health professionals was important for patients and encouraged shared understanding. Use of the vignette technique highlighted the gap between patient knowledge and action, with patients and professionals emphasizing their own responsibilities in relation to reduction of risk through education and action. Responses suggest that early positive interactions with appropriately trained professionals are needed to help patients assimilate advice into everyday routines.

Conclusions  For effective preventive care, patients need to understand how diabetes impacts on their health. Foot care education should begin early, be patient‐centred and delivered with empathy by professionals whom the patients trust. The findings reflect patient and professional expectations in educational practice, and therefore have relevance for other chronic conditions for which much education and advice is related to self‐care.
Patient priorities in colorectal cancer screening decisions1
Authors: Dolan James G.
Published: October 2005

Background  Colorectal cancer screening guidelines in the United States recommend that decisions about screening should incorporate patient preferences, but little is known about how patients make the trade‐offs inherent in choosing one of the five currently recommended screening programmes.

Study population  Forty‐eight primary care patients at average risk for colorectal cancer who completed an experimental shared decision‐making intervention based on a multicriteria decision analysis.

Methods  Descriptive analysis of priorities assigned to decision criteria describing the advantages and disadvantages of the five currently recommended colorectal screening programmes in the United States. Criteria were divided into four major criteria – avoid cancer, avoid screening side‐effects, avoid false positive test results and the combined importance of other considerations – and three subcriteria: the number of screening tests, test preparation and the test itself. Cluster analysis was used to identify common combinations of priorities within each set of criteria.

Results  Patients assigned widely variable priorities to both the criteria and subcriteria: the average range of priorities was 46 on a 100 point priority scale. Cluster analysis identified six different combinations of priorities for the major criteria and four for the subcriteria. The differences in priorities assigned to both the criteria and subcriteria in the clusters were statistically significant with P < 0.0001.

Conclusions  Even within a small group of patients, preferences vary widely regarding trade‐offs involved in choosing among the currently recommended colorectal cancer screening programmes in the United States. These results provide empiric support for recommendations to utilize a shared decision‐making process when making colorectal cancer screening decisions and highlight the need for additional research into how average risk patients view the trade‐offs inherent in choosing a colorectal cancer screening programme.
Patient, consumer, client, or customer: what do people want to be called?
Authors: Deber Raisa B. , Kraetschmer Nancy , Urowitz Sara , Sharpe Natasha
Published: October 2005

Objective  To clarify preferred labels for people receiving health care.

Background  The proper label to describe people receiving care has evoked considerable debate among providers and bio‐ethicists, but there is little evidence as to the preferences of the people involved.

Design  We analysed dictionary definitions as to the derivation and connotations of such potential labels as: patient, client, customer, consumer, partner and survivor. We then surveyed outpatients from four clinical populations in Ontario, Canada about their feelings about these labels.

Setting and participants  People from breast cancer (n = 202), prostate disease (n = 202) and fracture (n = 202) clinics in an urban Canadian teaching hospital (Sharpe study), and people with HIV/AIDS at 10 specialty care clinics and three primary care practices affiliated with the HIV Ontario Observational Database (n = 431).

Variables and outcome measures  The survey instruments included questions about opinion of label, role in treatment decision‐making (the Problem Solving Decision Making scale), trust, use of information and health status.

Results  Our respondents moderately liked the label ‘patient’. The other alternatives evoked moderate to strong dislike.

Conclusions  Many alternatives to ‘patient’ incorporate assumptions (e.g. a market relationship) which care recipients may also find objectionable. People who are receiving care find the label ‘patient’ much less objectionable than the alternatives that have been suggested.
A consultation leaflet to improve an older patient's involvement in general practice care: a randomized trial
Authors: Wetzels Raymond , Wensing Michel , van Weel Chris , Grol Richard
Published: October 2005

Objective  To evaluate the effects of a programme to enhance the involvement of older patients in their consultations in general practice.

Design  Cluster randomized trial, in which data was collected from different cohorts.

Setting and participants  Twenty‐five general practices in the south‐east part of the Netherlands and their patients aged 70 years and over.

Intervention  Patients in the intervention group received a leaflet to help them prepare for the consultation. General practitioners (GPs) received an outreach visit to optimize older patients’ involvement when visiting their GP. Patients in the control group received usual care.

Main outcome measures  Questionnaires measuring involvement (COMRADE), enablement (Patient Enablement Index) and satisfaction with their care (EUROPEP).

Results  Pre‐intervention 315 patients and post‐intervention 263 patients were included. Subjects were satisfied with their involvement and the GP's behaviour during the consultation. No differences in effect as a result of the leaflet on involvement, enablement or satisfaction were found between the intervention and the control group. Of 318 patients who received the leaflet and visited their GP in the intervention period, 47 patients used the leaflet. These users were more accustomed to prepare themselves for consultations. Users reported more psychological problems than non‐users.

Conclusions  No relevant effects of the implementation programme on involvement, enablement or satisfaction were found. Other strategies are needed to enhance involvement of older patients in their care. Alternatively, older patients may perceive themselves sufficiently involved.