A randomized comparison of three prandial insulin dosing algorithms for children and adolescents with Type 1 diabetes.

AIM: To compare systematically the impact of two novel insulin-dosing algorithms (the Pankowska Equation and the Food Insulin Index) with carbohydrate counting on postprandial glucose excursions following a high fat and a high protein meal. METHODS: A randomized, crossover trial at two Paediatric Diabetes centres was conducted. On each day, participants consumed a high protein or high fat meal with similar carbohydrate amounts. Insulin was delivered according to carbohydrate counting, the Pankowska Equation or the Food Insulin Index. Subjects fasted for 5 h following the test meal and physical activity was standardized. Postprandial glycaemia was measured for 300 min using continuous glucose monitoring. RESULTS: 33 children participated in the study. When compared to carbohydrate counting, the Pankowska Equation resulted in lower glycaemic excursion for 90-240 min after the high protein meal (p < 0.05) and lower peak glycaemic excursion (p < 0.05). The risk of hypoglycaemia was significantly lower for carbohydrate counting and the Food Insulin Index compared to the Pankowska Equation (OR 0.76 carbohydrate counting vs. the Pankowska Equation and 0.81 the Food Insulin Index vs. the Pankowska Equation). There was no significant difference in glycaemic excursions when carbohydrate counting was compared to the Food Insulin Index. CONCLUSION: The Pankowska Equation resulted in reduced postprandial hyperglycaemia at the expense of an increase in hypoglycaemia. There were no significant differences when carbohydrate counting was compared to the Food Insulin Index. Further research is required to optimize prandial insulin dosing.

Reproducibility of diagnostic criteria associated with atypical breast cytology.

OBJECTIVE: The aim of this project was to assess the interobserver and intraobserver variability when identifying cytological criteria, which were found to have a statistically significant association with C3 within a workplace environment. METHODS: Sixty C3 cases with known endpoints of malignant, benign proliferative or benign non-proliferative diagnoses were blindly and independently screened by seven experienced cytologists to identify previously reported statistically significant criteria associated with the C3 category. The criteria included the presence of myoepithelial cells or bare bipolar nuclei, cohesiveness, cystic background, papillary fragments with fibrovascular cores and tubular structures. Kappa statistics were used to measure interobserver variability. Two cytologists repeated the process 6 months later to obtain intraobserver data. RESULTS: The interobserver agreement was poor for all criteria except tubules which performed badly. The intraobserver variability for the two cytologists showed that one cytologist achieved moderate intraobserver agreement for all the criteria except cohesion which was poor, whilst the second cytologist showed poor agreement for all criteria. The reasons for the variability are multifactorial and include threshold effects where criteria lack good definition or error in identifying the criteria. CONCLUSION: Interobserver and intraobserver variability remains a significant challenge for cytologists. Despite attempts to define significant criteria associated with C3, good reproducibility could not be achieved. The C3 category is imprecise and highlights the inadequacy of the current classification reporting categories for breast FNA. The impending review of reporting breast cytology by the International Academy of Cytology is timely and appropriate.

Optimizing the combination insulin bolus split for a high-fat, high-protein meal in children and adolescents using insulin pump therapy.

AIMS: To determine the optimum combination bolus split to maintain postprandial glycaemia with a high-fat and high-protein meal in young people with Type 1 diabetes. METHODS: A total of 19 young people (mean age 12.9 ± 6.7 years) participated in a randomized, repeated-measures trial comparing postprandial glycaemic control across six study conditions after a high-fat and high-protein meal. A standard bolus and five different combination boluses were delivered over 2 h in the following splits: 70/30 = 70% standard /30% extended bolus; 60/40=60% standard/40% extended bolus; 50/50=50% standard/50% extended bolus; 40/60=40% standard/60% extended bolus; and 30/70=30% standard/70% extended bolus. Insulin dose was determined using the participant's optimized insulin:carbohydrate ratio. Continuous glucose monitoring was used to assess glucose excursions for 6 h after the test meal. RESULTS: Standard bolus and combination boluses 70/30 and 60/40 controlled the glucose excursion up to 120 min. From 240 to 300 min after the meal, the glucose area under the curve was significantly lower for combination bolus 30/70 compared with standard bolus (P=0.004). CONCLUSIONS: High-fat and high-protein meals require a ≥60% insulin:carbohydrate ratio as a standard bolus to control the initial postprandial rise. Additional insulin at an insulin:carbohydrate ratio of up to 70% is needed in the extended bolus for a high fat and protein meal to prevent delayed hyperglycaemia.

Increasing the protein quantity in a meal results in dose-dependent effects on postprandial glucose levels in individuals with Type 1 diabetes mellitus.

AIM: To determine the glycaemic impact of increasing protein quantities when consumed with consistent amounts of carbohydrate in individuals with Type 1 diabetes on intensive insulin therapy. METHODS: Participants with Type 1 diabetes [aged 10-40 years, HbA1c ≤ 64 mmol/mol (8%), BMI ≤ 91st percentile] received a 30-g carbohydrate (negligible fat) test drink daily over 5 days in randomized order. Protein (whey isolate 0 g/kg carbohydrate, 0 g/kg lipid) was added in amounts of 0 (control), 12.5, 25, 50 and 75 g. A standardized dose of insulin was given for the carbohydrate. Postprandial glycaemia was assessed by 5 h of continuous glucose monitoring. RESULTS: Data were collected from 27 participants (15 male). A dose-response relationship was found with increasing amount of protein. A significant negative relationship between protein dose and mean excursion was seen at the 30- and 60-min time points (P = 0.007 and P = 0.002, respectively). No significant relationship was seen at the 90- and 120-min time points. Thereafter, the dose-response relationship inverted, such that there was a significant positive relationship for each of the 150-300-min time points (P < 0.004). Mean glycaemic excursions were significantly greater for all protein-added test drinks from 150 to 300 min (P < 0.005) with the 75-g protein load, resulting in a mean excursion that was 5 mmol/l higher when compared with the control test drink (P < 0.001). CONCLUSIONS: Increasing protein quantity in a low-fat meal containing consistent amounts of carbohydrate decreases glucose excursions in the early (0-60-min) postprandial period and then increases in the later postprandial period in a dose-dependent manner.

Heads Up: a pilot trial of a psychological intervention to improve nutrition in head and neck cancer patients undergoing radiotherapy.

Malnutrition in head and neck cancer (HNC) patients is common and associated with poorer radiotherapy outcomes including increased mortality. This pilot trial investigates the feasibility and effectiveness of a psychological intervention to improve nutritional status, depression and mortality in HNC patients undergoing radiotherapy. Fifty-nine intervention patients received motivational interviewing and cognitive behavioural therapy compared to 70 historical controls who received treatment as usual. Participants were assessed for nutrition, depression and mortality. There were no significant differences between groups in nutritional status, depression or mortality. Subgroup analyses among patients at greater nutritional risk (cancers of the oral cavity, pharynx, larynx) revealed a potentially clinically important reduction on the PG-SGA and lower mortality (31% of controls vs. 16% intervention; P = 0.03) in favour of the intervention condition. Potential benefits in nutritional status and in mortality in this pilot trial of a psychological intervention among HNC patients at high nutritional risk suggest that a larger randomised controlled trial is warranted.

Stepped wedge cluster randomised trials: a review of the statistical methodology used and available.

BACKGROUND: Previous reviews have focussed on the rationale for employing the stepped wedge design (SWD), the areas of research to which the design has been applied and the general characteristics of the design. However these did not focus on the statistical methods nor addressed the appropriateness of sample size methods used.This was a review of the literature of the statistical methodology used in stepped wedge cluster randomised trials. METHODS: Literature Review. The Medline, Embase, PsycINFO, CINAHL and Cochrane databases were searched for methodological guides and RCTs which employed the stepped wedge design. RESULTS: This review identified 102 trials which employed the stepped wedge design compared to 37 from the most recent review by Beard et al. 2015. Forty six trials were cohort designs and 45 % (n = 46) had fewer than 10 clusters. Of the 42 articles discussing the design methodology 10 covered analysis and seven covered sample size. For cohort stepped wedge designs there was only one paper considering analysis and one considering sample size methods. Most trials employed either a GEE or mixed model approach to analysis (n = 77) but only 22 trials (22 %) estimated sample size in a way which accounted for the stepped wedge design that was subsequently used. CONCLUSIONS: Many studies which employ the stepped wedge design have few clusters but use methods of analysis which may require more clusters for unbiased and efficient intervention effect estimates. There is the need for research on the minimum number of clusters required for both types of stepped wedge design. Researchers should distinguish in the sample size calculation between cohort and cross sectional stepped wedge designs. Further research is needed on the effect of adjusting for the potential confounding of time on the study power.

Influence of dietary protein on postprandial blood glucose levels in individuals with Type 1 diabetes mellitus using intensive insulin therapy.

AIM: To determine the effects of protein alone (independent of fat and carbohydrate) on postprandial glycaemia in individuals with Type 1 diabetes mellitus using intensive insulin therapy. METHODS: Participants with Type 1 diabetes mellitus aged 7-40 years consumed six 150 ml whey isolate protein drinks [0 g (control), 12.5, 25, 50, 75 and 100] and two 150 ml glucose drinks (10 and 20 g) without insulin, in randomized order over 8 days, 4 h after the evening meal. Continuous glucose monitoring was used to assess postprandial glycaemia. RESULTS: Data were collected from 27 participants. Protein loads of 12.5 and 50 g did not result in significant postprandial glycaemic excursions compared with control (water) throughout the 300 min study period (P > 0.05). Protein loads of 75 and 100 g resulted in lower glycaemic excursions than control in the 60-120 min postprandial interval, but higher excursions in the 180-300 min interval. In comparison with 20 g glucose, the large protein loads resulted in significantly delayed and sustained glucose excursions, commencing at 180 min and continuing to 5 h. CONCLUSIONS: Seventy-five grams or more of protein alone significantly increases postprandial glycaemia from 3 to 5 h in people with Type 1 diabetes mellitus using intensive insulin therapy. The glycaemic profiles resulting from high protein loads differ significantly from the excursion from glucose in terms of time to peak glucose and duration of the glycaemic excursion. This research supports recommendations for insulin dosing for large amounts of protein.

Effects of short-term oral corticosteroid intake on dietary intake, body weight and body composition in adults with asthma - a randomized controlled trial.

BACKGROUND: Oral corticosteroids (OCS) are an efficacious treatment for asthma exacerbations, yet risk of adverse effects may decrease patient adherence to therapy. In particular, changes in appetite and dietary intake, which lead to weight gain and changes in body composition, are considered undesirable. OBJECTIVE: To determine whether 10-day OCS therapy in adults with asthma causes changes in leptin, appetite, dietary intake, body weight and body composition. METHODS: Double-blinded, placebo-controlled randomized cross-over trial of 10 days prednisolone (50 mg) in adults with stable asthma (n = 55) (ACTRN12611000562976). Pre- and post-assessment included spirometry, body weight, body composition measured by dual-energy X-ray absorptiometry and bioelectrical impedance analysis, appetite measured using a validated visual analogue scale (VAS) and dietary intake assessed using 4-day food records. Leptin was measured as a biomarker of appetite and eosinophils as an adherence biomarker. Outcomes were analysed by generalized linear mixed models. RESULTS: Subject adherence was confirmed by a significant decrease in blood eosinophils (× 10(9) /L) following prednisolone compared to placebo [Coef. -0.29, 95% CI: (-0.39, -0.19) P < 0.001]. There was no difference in serum leptin (ng/mL) [Coef. 0.13, 95% CI: (-3.47, 3.72) P = 0.945] or appetite measured by VAS (mm) [Coef. -4.93, 95% CI: (-13.64, 3.79) P = 0.267] following prednisolone vs. placebo. There was no difference in dietary intake (kJ/day) [Coef. 255, 95% CI: (-380, 891) P = 0.431], body weight (kg) [Coef. -0.38, 95% CI: (-0.81, 0.05) P = 0.083] or body fat (%) [Coef. -0.31, 95% CI: (-0.81, 0.20) P = 0.230]. Symptoms including sleep and gastrointestinal disturbance were reported significantly more often during prednisolone vs. placebo. CONCLUSIONS AND CLINICAL RELEVANCE: Short-term OCS in stable asthma did not induce significant changes in appetite, dietary intake, body weight or composition, although other adverse effects may require medical management. This evidence may assist in increasing medication adherence of asthmatics prescribed OCS for exacerbations.

The fraction of exhaled nitric oxide improves prediction of clinical allergic reaction to peanut challenge in children.

BACKGROUND: Retrospective studies of childhood peanut allergy demonstrate serum-specific IgE (IgE) levels against the peanut allergen Ara h2 may help predict a clinical reaction at food challenge. Fraction of exhaled nitric oxide (FeNO) is a non-invasive tool correlating to allergic airways inflammation and has been independently associated with increased food-specific IgE. OBJECTIVE: To assess the validity of serum-specific Ara h2 IgE measured prospectively to diagnose peanut allergy and explore the utility of FeNO as a non-invasive screening tool for childhood food challenge. METHODS: We recruited 53 participants from a cohort of consecutive children scheduled for an open-labelled peanut food challenge (OFC) by their paediatric allergist. Participants underwent skin prick test (SPT) measurement for sensitization to whole peanut extract, and serum was collected for Ara h2-specific IgE. FeNO was also measured in all cooperative children before the challenge. OFC and assessment of reaction were undertaken by clinicians blinded to test results. RESULTS: Ara h2-specific IgE and FeNO each showed improved diagnostic accuracy when compared to SPT. Receiver operator characteristic curve analysis gave an area under the curve (AUC) for Ara h2 sIgE of 0.84 (95% CI, 0.72-0.96). The AUC for FeNO, 0.83 (95% CI, 0.71-0.95), was equivalent to that of Ara h2. Combined AUC for SPT, sIgE to Ara h2 and FeNO was 0.96 (95% CI 0.90-1.00). There was no correlation between FeNO and serum nitrite levels (rs = -0.13, P = 0.6, n = 18). CONCLUSION AND CLINICAL RELEVANCE: Prospectively measured Ara h2-specific IgE improves diagnostic accuracy and reduces unsuccessful challenge to peanut. FeNO levels may provide improved diagnostic accuracy in a paediatric population undergoing OFC. The proposed FeNO-based diagnostic algorithm requires further validation studies.

Translating the use of an enriched environment poststroke from bench to bedside: study design and protocol used to test the feasibility of environmental enrichment on stroke patients in rehabilitation.

RATIONALE: Environmental enrichment, a paradigm investigated extensively in animal models, is an intervention, which by design facilitates motor, sensory, social, and cognitive activity. It has been shown to improve poststroke motor and cognitive function in animal models of stroke. This is the first study to attempt to translate this intervention from the laboratory to the clinical setting. AIMS: The overall aim of this pilot study is to test the feasibility of using environmental enrichment with stroke patients in a rehabilitation setting. The aim is to enrich the environment of stroke survivors in a rehabilitation ward and measure changes in their activity (physical, cognitive, and social activity). DESIGN: Prospective nonrandomized block design intervention study. STUDY: In the control phase we will determine the change in activity levels of patients treated in a usual rehabilitation environment over time. In the intervention phase structured observational techniques (behavioural mapping) will be used to quantify the change in activity levels of patients exposed to environmental enrichment. OUTCOMES: The primary outcome is change in activity level. Additional data collected on entry to and exit from the study will include: cognitive function using a battery of cognitive tests, general function using the Functional Independence Measure, mood using the Patient Health Questionnaire 9 and boredom using the Stroke Rehabilitation Boredom Survey. Quality of life will be assessed using the Assessment of Quality of Life 1 month postdischarge from rehabilitation. Australian New Zealand Clinical Trials Registry# ACTRN12611000629932.

In children using intensive insulin therapy, a 20-g variation in carbohydrate amount significantly impacts on postprandial glycaemia.

AIM: To determine if an insulin dose calculated for a meal containing 60 g carbohydrate maintains postprandial glycaemic control for meals containing 40, 50, 70 or 80 g carbohydrate. METHODS: Thirty-four young people (age range 8.5-17.7 years) using intensive insulin therapy consumed five test breakfasts with equivalent fat, protein and fibre contents but differing carbohydrate quantities (40, 50, 60, 70 and 80 g of carbohydrate). The preprandial insulin dose was the same for each meal, based on the subject's usual insulin:carbohydrate ratio for 60 g carbohydrate. Continuous glucose monitoring was used to monitor postprandial glucose over 180 min. RESULTS: The 40-g carbohydrate meal resulted in significantly more hypoglycaemia than the other meals (P = 0.003). There was a one in three chance of hypoglycaemia between 120 and 180 min if an insulin dose for 60 g carbohydrate was given for 40 g carbohydrate. The glucose levels of subjects on the 80-g meal were significantly higher than the 60- and 70-g carbohydrate meals at all time points between 150 and 180 min (P < 0.01). Subjects consuming the 80-g meal were more likely to have significant hyperglycaemia (blood glucose levels ≥ 12 mmol/l) compared with the other meals (P < 0.001). CONCLUSIONS: In patients using intensive insulin therapy, an individually calculated insulin dose for 60 g carbohydrate results in postprandial hypoglycaemia or hyperglycaemia for meals containing 40 and 80 g carbohydrate. To calculate mealtime insulin in order to maintain postprandial control, carbohydrate estimations should be within 10 g of the actual meal carbohydrate.

Death, dependency and health status 90 days following hospital admission for acute stroke in NSW.

BACKGROUND: Stroke is an Australian health priority area causing considerable levels of disability. We report 90-day outcomes for a cohort of acute stroke patients in New South Wales (NSW), Australia prior to randomization to a large cluster randomized controlled trial (CRCT), the Quality in Acute Stroke Care (QASC) trial. AIMS: This paper describes prospectively collected, 90-day outcome data for a cohort of NSW stroke patients, providing pre-intervention data for the QASC trial. METHODS: A consecutive sample of patients from acute stroke units in NSW was recruited. We measured patient death, disability (modified Rankin Score (mRS)), dependency (Barthel Index (BI)) and Health Status (Medical Outcomes Short-Form Health Survey (SF-36)) 90 days post-hospital admission. We also collected self-reported healthcare utilization and patient satisfaction with health professionals' advice and management to reduce risk of subsequent stroke. RESULTS: Ninety-day outcome data were obtained for 687 patients, of which, 335 (49%) had an mRS ≥2; 44 patients (6.4%) had died. For the 643 surviving patients, the mean BI was 87.2 (SD 21.9) and the mean scores for SF-36 Physical Component Summary score and Mental Component Summary score were 46.2 (SD 10.1) and 46.3 (SD 12.6) respectively. CONCLUSIONS: In this pre-intervention cohort of selected acute stroke inpatients, stroke severity was mild to moderate and subsequent clinical outcomes were favourable in the majority. The findings from this study provide a comprehensive description of 90-day health outcomes of patients who have experienced a mild-moderate stroke managed in stroke care units across metropolitan NSW and provide valuable data to inform the subsequent cluster trial.

Can children with Type 1 diabetes and their caregivers estimate the carbohydrate content of meals and snacks?

AIMS: Carbohydrate (CHO) counting allows children with Type 1 diabetes to adjust mealtime insulin dose to carbohydrate intake. Little is known about the ability of children to count CHO and whether a particular method for assessing CHO quantity is better than others. We investigated how accurately children and their caregivers estimate carbohydrate, and whether counting in gram increments improves accuracy compared with CHO portions or exchanges. METHODS: One hundred and two children and adolescents (age range 8.3-18.1 years) on intensive insulin therapy and 110 caregivers independently estimated the CHO content of 17 standardized meals (containing 8-90 g CHO), using whichever method of carbohydrate quantification they had been taught (gram increments, 10-g portions or 15-g exchanges). RESULTS: Seventy-three per cent (n = 2530) of all estimates were within 10-15 g of actual CHO content. There was no relationship between the mean percentage error and method of carbohydrate counting or glycated haemoglobin (HbA(1c)) (P > 0.05). Mean gram error and meal size were negatively correlated (r = -0.70, P < 0.0001). The longer children had been CHO counting the greater the mean percentage error (r = 0.173, P = 0.014). Core foods in non-standard quantities were most frequently inaccurately estimated, while individually labelled foods were most often accurately estimated. CONCLUSIONS: Children with Type 1 diabetes and their caregivers can estimate the carbohydrate content of meals with reasonable accuracy. Teaching CHO counting in gram increments did not improve accuracy compared with CHO portions or exchanges. Large meals tended to be underestimated and snacks overestimated. Repeated age-appropriate education appears necessary to maintain accuracy in carbohydrate estimations.

Assessment of dietary fat intake and innate immune activation as risk factors for impaired lung function.

BACKGROUND/OBJECTIVES: Preservation of lung health with aging is an important health issue in the general population, as loss of lung function with aging can lead to the development of obstructive lung disease and is a predictor of all-cause and cardiovascular mortality. Inflammation is increasingly linked to loss of lung function and evidence suggests that consumption of dietary fat exacerbates inflammation. We aimed to determine the association between dietary fat intake and lung function in older people. SUBJECTS/METHODS: Participants from the Hunter community study, a population-based cohort, were recruited during 2004 and 2005. Participants received a clinical assessment, including spirometry, and provided a blood sample. Diets were analyzed using food-frequency questionnaires. Plasma interleukin (IL)-6 and C-reactive protein was measured by Enzyme-Linked immunosorbent assay. RESULTS: Using backward stepwise linear regression, %energy from dietary fat, age and plasma IL-6 were considered as negative predictors of forced expiratory volume in one second (FEV(1)) in men. Also in men, % energy intake from dietary fat, age, body mass index and IL-6 were negative predictors of %predicted forced vital capacity (FVC). Smoking and age were negative predictors of FEV(1)/FVC. In women, plasma IL-6 and age were negative predictors of %FVC, whereas obesity was positively associated with FEV(1)/FVC. CONCLUSIONS: An increased proportion of fat in the diet is associated with the reduced lung function in older men. Dietary-fat induced innate immune activation and IL-6 release may contribute to this effect. Dietary interventions involving fat restriction should be further investigated as means of preserving lung function with aging.

Does an advanced insulin education programme improve outcomes and health service use for people with Type 2 diabetes? A 5-year follow-up of the Newcastle Empowerment course.

OBJECTIVE: To show that an advanced diabetes education programme delivers sustained benefits to people with diabetes prescribed insulin and healthcare providers over and above those provided by basic diabetes education. METHODS: An historical cohort study of 68 people with Type 1 and 51 people with Type 2 diabetes on insulin who attended the 4-day Newcastle Empowerment programme in 2001 and 2002 compared with 71 people with Type 1 and 312 people with Type 2 diabetes who attended only the basic 4-day insulin education programme over the same period, followed until 2007. Primary outcome was all hospital admissions and emergency visits; secondary outcomes were the composite of first cardiac event or death and readmission for diabetes complications. Cox-proportional hazards regression was used to analyse Type 1 and Type 2 diabetes separately. RESULTS: The empowerment programme significantly delayed time to first hospital admission/visit for patients with Type 2 diabetes; the hazard ratio (HR) of 0.41 (P = 0.01) translates into a delay of almost 3 years; this was partly driven by a significant reduction in cardiovascular events and mortality (HR = 0.24, P = 0.01). These effects were not seen for people with Type 1 diabetes. CONCLUSIONS: A one-time, advanced diabetes education programme teaching intensive insulin self-management with an empowerment style can lead to sustained improvement in patient outcomes and reduce use of hospital services for people with Type 2 diabetes on insulin.

Maternal vitamin D deficiency, ethnicity and gestational diabetes.

AIMS: Vitamin D deficiency has been linked to impaired glucose metabolism. We determined whether serum 25-hydroxyvitamin D (25OHD) is associated with glucose metabolism in pregnant women and the effect of ethnicity on this relationship. METHODS: We analysed serum 25OHD concentrations in 307 pregnant women attending a metropolitan obstetric clinic between October 2003 and May 2005. Measurements from 264 of the women were taken at the time of glucose tolerance testing at mid-gestation, a population therefore at increased risk for gestational diabetes. Pearson correlation analysis was used to test for univariate linear relationships between the natural log of serum 25OHD (ln-25OHD) and other variables. Multiple regression analysis was used to adjust for confounding factors. RESULTS: Mean serum 25OHD concentration was 53.8 +/- 23.9 nmol/l (sd). Ln-25OHD was negatively correlated with serum parathyroid hormone as expected (r -0.24, confidence intervals -0.35 to -0.12). Ln-25OHD was also negatively correlated with fasting plasma glucose (r-0.20, -0.31 to -0.08), fasting insulin (r -0.20, -0.31 to -0.08) and insulin resistance as calculated by homeostasis model assessment (r -0.21, -0.32 to -0.09). The association between fasting glucose and log-transformed 25OHD concentration was of borderline significance after accounting for ethnicity, age and body mass index in multivariate analyses (-0.13, -0.26 to 0.01). The odds ratio of gestational diabetes in women with 25OHD < 50 nmol/l did not reach statistical significance (1.92, 95% confidence interval 0.89-4.17). CONCLUSIONS: Maternal 25OHD concentrations are inversely related to fasting glucose, although further studies are required to establish whether this is independent of the effects of ethnic background.

Pleasure or pain? A profile of smokers in Northern England.

OBJECTIVE: To construct a profile of smokers using multiple indices of physical, mental and social health. STUDY DESIGN: Cross-sectional study. METHODS: The setting was Wigan and Bolton Health Authority, an urban district in the North West of England. A random sample of over 15000 adults from the Health Authority adult population completed a written questionnaire. Prevalence ratios were calculated for physical, mental and social health indicators for smokers compared with non-smokers, adjusted for borough, age and deprivation score of place of residence. RESULTS: Smokers were less likely to report their current health as good, and reported a significantly higher prevalence of arthritis, bronchitis, backache and respiratory symptoms. Smokers had more mobility problems and recent severe pain. Smokers had less healthy lifestyles across many behaviours (e.g. poorer diet, taking less regular exercise and more problem drinking). Depression and the proportion of people with a high psychiatric morbidity score were increased. More women smokers reported a lack of social support, and smokers more often reported financial difficulties. Differences were exaggerated by comparing heavy smokers with non-smokers. CONCLUSIONS: Independent of the level of deprivation of their area of residence, smokers have poorer physical, social and mental health, with a dose-response effect. Smoking creates considerable pain, but little evidence of pleasure.

American, British and European recommendations for statins in the primary prevention of cardiovascular disease applied to British men studied prospectively.

OBJECTIVE: To compare national and international recommendations for statin treatment in the primary prevention of cardiovascular disease (CVD) in middle-aged men. DESIGN: Application of the current American, British and European recommendations to results of a prospective study. PARTICIPANTS: Men aged 49-65 years (n = 1653) who participated in the Caerphilly Prospective Study. MAIN OUTCOME MEASURES: Proportion of patients who would receive statin treatment, the number needed to treat (NNT) to prevent one first CVD event (myocardial infarction or stroke) over 10 years and the potential number of events prevented over 10 years in the whole population (population impact) by the use of statins in accordance with each set of guidelines, assuming a reduction of risk in the range 10-50% from the observed events and baseline risk factors. RESULTS: 212 events were noted. For an anticipated reduction in first CVD events of 30% with statin treatment, the NNT was 26.0, if the whole population was treated. The lowest NNT was 12.1 for the National Service Framework, achieved when only 14% of the men received a statin. This prevented the lowest number of events (19.2/212), however, and had the smallest population impact on CVD incidence (-9.1%). The American and earlier Joint British Societies guidelines, although giving NNTs of around 21, prevented more events and had a greater population impact of -21.6% to -23.3%. They did, however, target about 60% of the male population. The British Hypertension Society guidelines and new Joint British Societies recommendations achieved the greatest population impact of -27% while maintaining the NNT at 22.2. They did, however, target three quarters of this population. CONCLUSION: Even effective preventive treatment will have little impact in preventing disease if patients at typical risk are not treated. Whether cholesterol lowering on such a scale should be attempted with drugs raises philosophical, psychological and economic considerations, particularly in view of the high likelihood of individual benefit from statin treatment. More effective nutritional policies to reduce serum cholesterol on a population level and reduce the requirement for statins in primary prevention should also be considered.

Does routine assessment and real-time feedback improve cancer patients' psychosocial well-being?

This study examined the effectiveness of giving medical oncologists immediate feedback about cancer patients' self-reported psychosocial well-being in reducing those patients' levels of anxiety, depression, perceived needs and physical symptoms. Cancer patients attending one cancer centre for their first visit were allocated to intervention (n = 42) or control (n = 38) groups. All patients completed a computerized survey assessing their psychosocial well-being while waiting to see the oncologist. Intervention patients' responses were immediately scored and summary reports were placed in each patient's file for follow-up. A total of 48 participants (25 intervention and 23 control) completed the survey four times. Intervention patients who reported a debilitating physical symptom at visit 2 were significantly less likely to report a debilitating physical symptom at visit 3 compared with control patients (OR = 2.8, P = 0.04). Reductions in levels of anxiety, depression and perceived needs among intervention patients were not significantly different to control patients. Repeated collection and immediate feedback of patient-reported health information to oncologists has potential to improve patients' symptom control, but has little impact upon emotional well-being, including those at high risk. Future research should consider providing the feedback to other health professionals and patients, and monitor the impact on the process of individual patient care.