Petra Rauchhaus

A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial

BACKGROUND The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. METHODS We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index (BMI) of 28 kg/m(2) or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2-9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. FINDINGS 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95-5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64-5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon). INTERPRETATION The FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity. FUNDING Scottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06).

Invasive Breast Cancer: Relationship between Shear-wave Elastographic Findings and Histologic Prognostic Factors

PURPOSE To compare the histologic prognostic feature of invasive breast cancer with mean stiffness as measured with shear-wave elastography. MATERIALS AND METHODS This retrospective study was exempted from ethical committee review. Patient consent for use of images for research was obtained. The study group comprised 101 consecutive women (age range, 38-91 years) with solid lesions identified during routine breast ultrasonography (US) performed between April 2010 and March 2011 and subsequently confirmed at histologic examination to be invasive cancers. Four elastographic images in two orthogonal planes were obtained of each lesion, and mean stiffness values were obtained from each image. Histologic findings following surgery were used for comparison, namely histologic grade, tumor type, invasive size, vascular invasion status, and lymph node status. Relationship between mean stiffness and histologic parameters was investigated by using a general linear model and multiple regression analysis. RESULTS High histologic grade (P < .0001), large invasive size (P < .0001), lymph node involvement (P < .0001), tumor type (P < .0001), and vascular invasion (P = .0077) all showed statistically significant positive association with high mean stiffness values. Multiple linear regression indicated that invasive size is the strongest pathologic determinant of mean stiffness (P < .0001), with histologic grade also having significant influence (P = .022). CONCLUSION In this study, breast cancers with higher mean stiffness values at shear-wave elastography had poorer prognostic features.

The impact of a bodyweight and physical activity intervention (BeWEL) initiated through a national colorectal cancer screening programme: randomised controlled trial

Objective To evaluate the impact of a diet and physical activity intervention (BeWEL) on weight change in people with a body mass index >25 weight (kg)/height (m)2 at increased risk of colorectal cancer and other obesity related comorbidities. Design Multicentre, parallel group, randomised controlled trial. Setting Four Scottish National Health Service health boards. Participants 329 overweight or obese adults (aged 50 to 74 years) who had undergone colonoscopy after a positive faecal occult blood test result, as part of the national bowel screening programme, and had a diagnosis of adenoma confirmed by histopathology. 163 were randomised to intervention and 166 to control. Intervention Participants were randomised to a control group (weight loss booklet only) or 12 month intervention group (three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls). A goal of 7% reduction in body weight was set and participants received a personalised energy prescription (2508 kJ (600 kcal) below that required for weight maintenance) and bodyweight scales. Motivational interviewing techniques explored self assessed confidence, ambivalence, and personal values concerning weight. Behavioural strategies included goal setting, identifying intentions of implementation, self monitoring of body weight, and counsellor feedback about reported diet, physical activity, and weight change. Main outcome measures The primary outcome was weight change over 12 months. Secondary outcomes included changes in waist circumference, blood pressure, fasting cardiovascular biomarkers, and glucose metabolism variables, physical activity, diet, and alcohol consumption. Results At 12 months, data on the primary outcome were available for 148 (91%) participants in the intervention group and 157 (95%) in the control group. Mean weight loss was 3.50 kg (SD 4.91) (95% confidence interval 2.70 to 4.30) in the intervention group compared with 0.78 kg (SD 3.77) (0.19 to 1.38) in the control group. The group difference was 2.69 kg (95% confidence interval 1.70 to 3.67). Differences between groups were significant for waist circumference, body mass index, blood pressure, blood glucose level, diet, and physical activity. No reported adverse events were considered to be related to trial participation. Conclusions Significant weight loss can be achieved by a diet and physical activity intervention initiated within a national colorectal cancer screening programme, offering considerable potential for risk reduction of disease in older adults. Trial registration Current Controlled Trials ISRCTN53033856.

Can shear-wave elastography predict response to neoadjuvant chemotherapy in women with invasive breast cancer?

Background:Response of invasive breast cancer to neoadjuvant chemotherapy (NAC) is variable, and prediction of response is imperfect. We aimed to ascertain whether tissue stiffness in breast cancers, as assessed by shear-wave elastography (SWE) before treatment, is associated with response.Methods:We retrospectively compared pre-treatment tumour mean tissue stiffness, with post-treatment Residual Cancer Burden (RCB) scores and its components in 40 women with breast cancer treated by NAC using Pearson’s correlation coefficient (CC), a general linear model and multiple linear regression. Subgroup analysis was carried out for luminal, HER2-positive and basal immuno-histochemical subtypes.Results:Statistically significant correlations were shown between stiffness and RCB scores and between stiffness and percentage tumour cellularity. The correlation between stiffness and percentage cellularity was strongest (CC 0.35 (P<0.0001) compared with CC 0.23 (P=0.004) for the RCB score). The results of a general linear model show that cellularity and RCB score maintain independent relationships with stiffness. By multiple linear regression, only cellularity maintained a significant relationship with stiffness.Conclusion:Pre-treatment tumour stiffness measured by SWE, has a statistically significant relationship with pathological response of invasive breast cancer to NAC.

Evaluating the reliability, validity, acceptability, and practicality of SMS text messaging as a tool to collect research data: results from the Feeding Your Baby project.

OBJECTIVE To test the reliability, validity, acceptability, and practicality of short message service (SMS) messaging for collection of research data. MATERIALS AND METHODS The studies were carried out in a cohort of recently delivered women in Tayside, Scotland, UK, who were asked about their current infant feeding method and future feeding plans. Reliability was assessed by comparison of their responses to two SMS messages sent 1 day apart. Validity was assessed by comparison of their responses to text questions and the same question administered by phone 1 day later, by comparison with the same data collected from other sources, and by correlation with other related measures. Acceptability was evaluated using quantitative and qualitative questions, and practicality by analysis of a researcher log. RESULTS Reliability of the factual SMS message gave perfect agreement. Reliabilities for the numerical question were reasonable, with κ between 0.76 (95% CI 0.56 to 0.96) and 0.80 (95% CI 0.59 to 1.00). Validity for data compared with that collected by phone within 24 h (κ =0.92 (95% CI 0.84 to 1.00)) and with health visitor data (κ =0.85 (95% CI 0.73 to 0.97)) was excellent. Correlation validity between the text responses and other related demographic and clinical measures was as expected. Participants found the method a convenient and acceptable way of providing data. For researchers, SMS text messaging provided an easy and functional method of gathering a large volume of data. CONCLUSION In this sample and for these questions, SMS was a reliable and valid method for capturing research data.

Long-term effect of lithium maintenance therapy on estimated glomerular filtration rate in patients with affective disorders: a population-based cohort study

BACKGROUND For more than 40 years, the long-term effect of lithium maintenance therapy on renal function has been debated. We aimed to assess the effect of lithium maintenance therapy on estimated glomerular filtration rate (eFGR) in patients with affective disorders, and explore predictors for a decrease in eGFR. METHODS This population-based cohort study included adult patients (18-65 years of age at baseline) in Tayside (Scotland, UK) who had recently started on lithium maintenance treatment between Jan 1, 2000, and Dec 31, 2011 (retrospectively assigned to the lithium group) or those with exposure to other first-line drugs used in the treatment of affective disorders (quetiapine, olanzapine, and semisodium valproate) during the same period (retrospectively assigned to the comparator group). Patients had to have at least 6 months of (incidence) exposure to lithium or any of the comparator drugs, at least two eGFR values available in the observation period (one at baseline and at least one after ≥6 months post baseline). We excluded patients with previous exposure to lithium or one of the comparator drugs, those with a previous diagnosis of schizophrenia or other psychotic disorder, those with glomerular disease, tubulo-interstitial disease, or chronic kidney disease stages 4-5 at baseline, and those who had undergone renal transplant before exposure. Maximum follow-up was 12 years. Data were provided by the University of Dundee Health Informatics Centre, who have access to health-related population-based datasets containing data for every patient registered with a regional family doctor. Each patient has a unique ten-digit identifier, the Community Health Index, enabling us to link laboratory tests, dispensed community prescriptions, Scottish Morbidity Records, and mortality records to the patient. All data were anonymised according to Health Informatics Centre standard operating procedures. The primary outcome was the change per year in the eGFR, adjusted for age, sex, and baseline eGFR, and analysed by random coefficient models. FINDINGS 1120 patients (305 exposed to lithium and 815 to comparator drugs) qualified for inclusion, providing 13 963 eGFR values over 12 years. The mean duration of exposure to lithium was 55 months (SD 42; range 6-144). Mean annual decline in eGFR (adjusted for age, sex, and baseline eGFR) was 1·3 mL/min per 1·73 m(2) (SE 0·2) in the lithium group, which did not differ significantly to that in the comparator group (0·9 mL/min/1·73 m(2) [SE 0·15]). After adjustment for additional confounders, the monthly decline in eGFR attributable to lithium exposure amounted to 0·02 mL/min per 1·73 m(2) (SE 0·02, p=0·30). As a post-hoc secondary outcome, we estimated the annual decline in eGFR for the lithium group to be 1·0 mL/min per 1·73 m(2) (SE 0·2), which again did not differ significantly to that in the comparator group (0·4 mL/min/1·73 m(2) [SE 0·2]. Modelling identified significant predictors for eGFR decline as age, baseline eGFR, comorbidities, co-prescriptions of nephrotoxic drugs, and episodes of lithium toxicity; however, duration of exposure to lithium and mean serum lithium level were not significant predictors for eGFR decline. INTERPRETATION Our analysis suggests no effect of stable lithium maintenance therapy (lithium levels in therapeutic range) on the rate of change in eGFR over time. Our results therefore contradict the idea that long-term lithium therapy is associated with nephrotoxicity in the absence of episodes of acute intoxication and that duration of therapy and cumulative dose are the major determinants of toxicity. FUNDING None.

Common carotid intima media thickness and ankle-brachial pressure index correlate with local but not global atheroma burden: a cross sectional study using whole body magnetic resonance angiography.

Background Common carotid intima media thickness (CIMT) and ankle brachial pressure index (ABPI) are used as surrogate marker of atherosclerosis, and have been shown to correlate with arterial stiffness, however their correlation with global atherosclerotic burden has not been previously assessed. We compare CIMT and ABPI with atheroma burden as measured by whole body magnetic resonance angiography (WB-MRA). Methods 50 patients with symptomatic peripheral arterial disease were recruited. CIMT was measured using ultrasound while rest and exercise ABPI were performed. WB-MRA was performed in a 1.5T MRI scanner using 4 volume acquisitions with a divided dose of intravenous gadolinium gadoterate meglumine (Dotarem, Guerbet, FR). The WB-MRA data was divided into 31 anatomical arterial segments with each scored according to degree of luminal narrowing: 0 = normal, 1 = <50%, 2 = 50–70%, 3 = 70–99%, 4 = vessel occlusion. The segment scores were summed and from this a standardized atheroma score was calculated. Results The atherosclerotic burden was high with a standardised atheroma score of 39.5±11. Common CIMT showed a positive correlation with the whole body atheroma score (β 0.32, p = 0.045), however this was due to its strong correlation with the neck and thoracic segments (β 0.42 p = 0.01) with no correlation with the rest of the body. ABPI correlated with the whole body atheroma score (β −0.39, p = 0.012), which was due to a strong correlation with the ilio-femoral vessels with no correlation with the thoracic or neck vessels. On multiple linear regression, no correlation between CIMT and global atheroma burden was present (β 0.13 p = 0.45), while the correlation between ABPI and atheroma burden persisted (β −0.45 p = 0.005). Conclusion ABPI but not CIMT correlates with global atheroma burden as measured by whole body contrast enhanced magnetic resonance angiography in a population with symptomatic peripheral arterial disease. However this is primarily due to a strong correlation with ilio-femoral atheroma burden.

Prediction of initiation and cessation of breastfeeding from late pregnancy to 16 weeks: the Feeding Your Baby (FYB) cohort study.

Objective To derive prediction models for both initiation and cessation of breastfeeding using demographic, psychological and obstetric variables. Design A prospective cohort study. Setting Women delivering at Ninewells Hospital, Dundee, UK. Data sources Demographic data and psychological measures were obtained during pregnancy by questionnaire. Birth details, feeding method at birth and at hospital discharge were obtained from the Ninewells hospital database, Dundee, UK. Breastfeeding women were followed up by text messages every 2 weeks until 16 weeks or until breastfeeding was discontinued to ascertain feeding method and feeding intentions. Participants Pregnant women over 30 weeks gestation aged 16 years and above, living in Dundee, booked to deliver at Ninewells Hospital, Dundee, and able to speak English. Main outcome measure Initiation and cessation of breastfeeding. Results From the total cohort of women at delivery (n=344) 68% (95% CI 63% to 73%) of women had started breastfeeding at discharge. Significant predictors of initiating breastfeeding were older age, parity, greater intention to breastfeed from a Theory of Planned Behaviour (TPB)-based questionnaire, higher Iowa Infant Feeding Assessment Scale (IIFAS) score as well as living with a husband or partner. For the final model, the AUROC was 0.967. For those who initiated breastfeeding (n=233), the strongest predictors of stopping were low intention to breastfeed from TPB, low IIFAS score and non-managerial/professional occupations. Conclusions The findings from this study will be used to inform the protocol for an intervention study to encourage and support prolonged breastfeeding as intentions appear to be a key intervention focus for initiation. The predictive models could be used to identify women at high risk of not initiating and also women at high risk of stopping for interventions to improve the longevity of breastfeeding.

Chromosome 9p deletion in clear cell renal cell carcinoma predicts recurrence and survival following surgery

Background:Wider clinical applications of 9p status in clear cell renal cell carcinoma (ccRCC) are limited owing to the lack of validation and consensus for interphase fluorescent in situ hybridisation (I-FISH) scoring technique. The aim of this study was to analytically validate the applicability of I-FISH in assessing 9p deletion in ccRCC and to clinically assess its long-term prognostic impact following surgical excision of ccRCC.Methods:Tissue microarrays were constructed from 108 renal cell carcinoma (RCC) tumour paraffin blocks. Interphase fluorescent in situ hybridisation analysis was undertaken based on preset criteria by two independent observers to assess interobserver variability. 9p status in ccRCC tumours was determined and correlated to clinicopathological variables, recurrence-free survival and disease-specific survival.Results:There were 80 ccRCCs with valid 9p scoring and a median follow-up of 95 months. Kappa statistic for interobserver variability was 0.71 (good agreement). 9p deletion was detected in 44% of ccRCCs. 9p loss was associated with higher stage, larger tumours, necrosis, microvascular and renal vein invasion, and higher SSIGN (stage, size, grade and necrosis) score. Patients with 9p-deleted ccRCC were at a higher risk of recurrence (P=0.008) and RCC-specific mortality (P=0.001). On multivariate analysis, 9p deletion was an independent predictor of recurrence (hazard ratio 4.323; P=0.021) and RCC-specific mortality (hazard ratio 4.603; P=0.007). The predictive accuracy of SSIGN score improved from 87.7% to 93.1% by integrating 9p status to the model (P=0.001).Conclusions:Loss of 9p is associated with aggressive ccRCC and worse prognosis in patients following surgery. Our findings independently confirm the findings of previous reports relying on I-FISH to detect 9p (CDKN2A) deletion.

Increased cancer awareness among British adolescents after a school-based educational intervention: a controlled before-and-after study with 6-month follow-up

BackgroundThere is a lack of evidence around the effectiveness of school-based interventions designed to raise adolescents’ cancer awareness. To address this deficit this study assessed the impact of an intervention delivered in the United Kingdom by Teenage Cancer Trust on: recall (open question) and recognition (closed question) of cancer warning signs; knowledge of common childhood, teenage, male and female cancers; awareness of the relationship between cancer and age; anticipated medical help-seeking delay; perceived barriers to seeking medical advice about cancer; and examined variation of intervention effect by gender and whether adolescents reported that they knew someone with cancer.MethodsThe Cancer Awareness Measure (CAM) was completed by 422 adolescents (male: 221, 52.4%) aged 11-17 years old (mean age=13.8, standard deviation=1.26) two weeks before and two weeks after the intervention in three schools, and on two occasions four weeks apart in a fourth (control) school. Intervention schools were followed-up 6-months post-intervention.ResultsRecognition of nine common cancer warning signs significantly increased two weeks after the intervention (4.6 to 6.8, p<0.001) and was maintained at 6-month follow-up (6.2, p<0.001). Endorsement of emotional barriers to help-seeking ‘not confident to talk about symptoms’ (53% to 45%, p=0.021) and ‘worried about what the doctor might find’ (70% to 63%, p=0.021) significantly decreased two weeks after the intervention but changes were not maintained at 6-months. The intervention had a greater impact on females and those who knew someone with cancer.ConclusionsThe intervention is an effective way to raise adolescents’ cancer awareness, especially of cancer symptoms. Further development and evaluation is required to maximise intervention impact, particularly on barriers to help-seeking behaviour.