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Choosing an appropriate electronic data capture system (EDC) is a critical decision for all randomized controlled trials (RCT). In this paper, we document our process for developing and implementing an EDC for a multisite RCT evaluating the efficacy and implementation of an enhanced primary care model for individuals with opioid use disorder who are returning to the community from incarceration.
Informed by the Knowledge-to-Action conceptual framework and user-centered design principles, we used Claris Filemaker software to design and implement CRICIT, a novel EDC that could meet the varied needs of the many stakeholders involved in our study.
CRICIT was deployed in May 2021 and has been continuously iterated and adapted since. CRICIT’s features include extensive participant tracking capabilities, site-specific adaptability, integrated randomization protocols, and the ability to generate both site-specific and study-wide summary reports.
CRICIT is highly customizable, adaptable, and secure. Its implementation has enhanced the quality of the study’s data, increased fidelity to a complicated research protocol, and reduced research staff’s administrative burden. CRICIT and similar systems have the potential to streamline research activities and contribute to the efficient collection and utilization of clinical research data.
Differences in health outcomes between meat-eaters and non-meat-eaters might relate to differences in dietary intakes between these diet groups. We assessed intakes of major protein-source foods and other food groups in six groups of meat-eaters and non-meat-eaters participating in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Oxford study.
Materials and methods
Data were from 30, 239 participants who answered four questions regarding their consumption of meat, fish, dairy or eggs and completed a food frequency questionnaire (FFQ) in 2010. Participants were categorized as regular meat-eaters (> 50 grams of total/any meat per day: n = 12,997); low meat-eaters (< 50 grams of total/any meat per day: n = 4,650); poultry-eaters (poultry but no red meat: n = 591); fish-eaters (no meat but consumed fish: n = 4,528); vegetarians (no meat or fish: n = 6,672); and vegans (no animal products: n = 801). FFQ foods were categorised into 45 food groups. Analysis of variance was used to test for differences between age-adjusted mean intakes of each food group by diet group.
We found that regular meat-eaters, vegetarians and vegans, respectively, consumed about a third, quarter and a fifth of their total energy intake from high protein-source foods. Compared with regular meat-eaters, low and non-meat-eaters consumed higher amounts of high-protein meat alternatives (soy, legumes, pulses, nuts, seeds) and other plant-based foods (whole grains, vegetables, fruits) and lower amounts of refined grains, fried foods, alcohol, and sugar-sweetened beverages.
Overall, our results suggest that there were large differences in the amounts and types of protein-rich and other foods eaten by regular, low and non-meat-eaters. These findings provide insight into potential nutritional explanations for differences in health outcomes between diet groups.
Pattern analysis has emerged as a tool to depict the role of multiple nutrients/foods in relation to health outcomes. The present study aimed at extracting nutrient patterns with respect to breast cancer (BC) aetiology.
Nutrient patterns were derived with treelet transform (TT) and related to BC risk. TT was applied to twenty-three log-transformed nutrient densities from dietary questionnaires. Hazard ratios (HR) and 95 % confidence intervals computed using Cox proportional hazards models quantified the association between quintiles of nutrient pattern scores and risk of overall BC, and by hormonal receptor and menopausal status. Principal component analysis was applied for comparison.
The European Prospective Investigation into Cancer and Nutrition (EPIC).
Women (n 334 850) from the EPIC study.
The first TT component (TC1) highlighted a pattern rich in nutrients found in animal foods loading on cholesterol, protein, retinol, vitamins B12 and D, while the second TT component (TC2) reflected a diet rich in β-carotene, riboflavin, thiamin, vitamins C and B6, fibre, Fe, Ca, K, Mg, P and folate. While TC1 was not associated with BC risk, TC2 was inversely associated with BC risk overall (HRQ5 v. Q1=0·89, 95 % CI 0·83, 0·95, Ptrend<0·01) and showed a significantly lower risk in oestrogen receptor-positive (HRQ5 v. Q1=0·89, 95 % CI 0·81, 0·98, Ptrend=0·02) and progesterone receptor-positive tumours (HRQ5 v. Q1=0·87, 95 % CI 0·77, 0·98, Ptrend<0·01).
TT produces readily interpretable sparse components explaining similar amounts of variation as principal component analysis. Our results suggest that participants with a nutrient pattern high in micronutrients found in vegetables, fruits and cereals had a lower risk of BC.
Whole-grain intake has been reported to be associated with a lower risk of several lifestyle-related diseases such as type 2 diabetes, CVD and some types of cancers. As measurement errors in self-reported whole-grain intake assessments can be substantial, dietary biomarkers are relevant to be used as complementary tools for dietary intake assessment. Alkylresorcinols (AR) are phenolic lipids found almost exclusively in whole-grain wheat and rye products among the commonly consumed foods and are considered as valid biomarkers of the intake of these products. In the present study, we analysed the plasma concentrations of five AR homologues in 2845 participants from ten European countries from a nested case–control study in the European Prospective Investigation into Cancer and Nutrition. High concentrations of plasma total AR were found in participants from Scandinavia and Central Europe and lower concentrations in those from the Mediterranean countries. The geometric mean plasma total AR concentrations were between 35 and 41 nmol/l in samples drawn from fasting participants in the Central European and Scandinavian countries and below 23 nmol/l in those of participants from the Mediterranean countries. The whole-grain source (wheat or rye) could be determined using the ratio of two of the homologues. The main source was wheat in Greece, Italy, the Netherlands and the UK, whereas rye was also consumed in considerable amounts in Germany, Denmark and Sweden. The present study demonstrates a considerable variation in the plasma concentrations of total AR and concentrations of AR homologues across ten European countries, reflecting both quantitative and qualitative differences in the intake of whole-grain wheat and rye.
Vegetarians and vegans exclude certain food sources of vitamin D from their diet, but it is not clear to what extent this affects plasma concentrations of 25-hydroxyvitamin D (25(OH)D). The objective was to investigate differences in vitamin D intake and plasma concentrations of 25(OH)D among meat eaters, fish eaters, vegetarians and vegans.
A cross-sectional analysis.
Plasma 25(OH)D concentrations were measured in 2107 white men and women (1388 meat eaters, 210 fish eaters, 420 vegetarians and eighty-nine vegans) aged 20–76 years from the European Prospective Investigation into Cancer and Nutrition (EPIC)–Oxford cohort.
Plasma 25(OH)D concentrations reflected the degree of animal product exclusion and, hence, dietary intake of vitamin D; meat eaters had the highest mean intake of vitamin D (3·1 (95 % CI 3·0, 3·2) μg/d) and mean plasma 25(OH)D concentrations (77·0 (95 % CI 75·4, 78·8) nmol/l) and vegans the lowest (0·7 (95 % CI 0·6, 0·8) μg/d and 55·8 (95 % CI 51·0, 61·0) nmol/l, respectively). The magnitude of difference in 25(OH)D concentrations between meat eaters and vegans was smaller (20 %) among those participants who had a blood sample collected during the summer months (July–September) compared with the winter months (38 %; January–March). The prevalence of low plasma concentrations of 25(OH)D (<25 nmol/l) during the winter and spring ranged from <1 % to 8 % across the diet groups.
Plasma 25(OH)D concentrations were lower in vegetarians and vegans than in meat and fish eaters; diet is an important determinant of plasma 25(OH)D in this British population.
Epidemiological data suggest that a diet rich in animal foods may be associated with an increased risk of several cancers, including cancers of the prostate, colorectum and breast, but the possible mechanism is unclear. It is hypothesised that phytanic acid, a C20 branched-chain fatty acid found predominantly in foods from ruminant animals, may be involved in early cancer development because it has been shown to up regulate activity of α-methylacyl-coenzyme A racemase, an enzyme commonly found to be over-expressed in tumour cells compared with normal tissue. However, little is known about the distribution of plasma phytanic acid concentrations or its dietary determinants in the general population. The primary aim of the present cross-sectional study was to determine circulating phytanic acid concentrations among ninety-six meat-eating, lacto-ovo-vegetarian and vegan women, aged 20–69 years, recruited into the Oxford component of the European Prospective Investigation into Cancer and Nutrition (EPIC-Oxford). Meat-eaters had, on average, a 6.7-fold higher geometric mean plasma phytanic acid concentration than the vegans (5·77 v. 0·86 μmol/l; P < 0·0001) and a 47 % higher mean concentration than the vegetarians (5·77 v. 3·93 μmol/l; P = 0·016). The strongest determinant of plasma phytanic acid concentration appeared to be dairy fat intake (r 0·68; P < 0·0001); phytanic acid levels were not associated with age or other lifestyle factors. These data show that a diet high in fat from dairy products is associated with increased plasma phytanic acid concentration, which may play a role in cancer development.
To assess the epidemiological evidence on diet and cancer and make public health recommendations.
Review of published studies, concentrating on recent systematic reviews, meta-analyses and large prospective studies.
Conclusions and recommendations:
Overweight/obesity increases the risk for cancers of the oesophagus (adenocarcinoma), colorectum, breast (postmenopausal), endometrium and kidney; body weight should be maintained in the body mass index range of 18.5–25?kg/m2, and weight gain in adulthood avoided. Alcohol causes cancers of the oral cavity, pharynx, oesophagus and liver, and a small increase in the risk for breast cancer; if consumed, alcohol intake should not exceed 2?units/d. Aflatoxin in foods causes liver cancer, although its importance in the absence of hepatitis virus infections is not clear; exposure to aflatoxin in foods should be minimised. Chinese-style salted fish increases the risk for nasopharyngeal cancer, particularly if eaten during childhood, and should be eaten only in moderation. Fruits and vegetables probably reduce the risk for cancers of the oral cavity, oesophagus, stomach and colorectum, and diets should include at least 400?g/d of total fruits and vegetables. Preserved meat and red meat probably increase the risk for colorectal cancer; if eaten, consumption of these foods should be moderate. Salt preserved foods and high salt intake probably increase the risk for stomach cancer; overall consumption of salt preserved foods and salt should be moderate. Very hot drinks and foods probably increase the risk for cancers of the oral cavity, pharynx and oesophagus; drinks and foods should not be consumed when they are scalding hot. Physical activity, the main determinant of energy expenditure, reduces the risk for colorectal cancer and probably reduces the risk for breast cancer; regular physical activity should be taken.
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