Athene Lane

Inverse relationship between alcohol consumption and active Helicobacter pylori infection: the Bristol Helicobacter project

OBJECTIVE:The aim of this study was to examine whether smoking or consumption of alcohol or coffee is associated with active Helicobacter pylori (H. pylori) infection.METHODS:This was a cross-sectional population study conducted as part of a randomized controlled trial of H. pylori infection eradication in southwest England. A total of 10,537 subjects, recruited from seven general practices, underwent 13C-urea breath testing for active infection with H. pylori and provided data on smoking, usual weekly consumption of alcohol, and daily intake of coffee.RESULTS:Smoking or coffee consumption were not related to active H. pylori infection. Total alcohol consumption was associated with a small, but not statistically significant, decrease in the odds of infection. After adjustment for age, sex, ethnic status, childhood and adult social class, smoking, coffee consumption, and intake of alcoholic beverages other than wine, subjects drinking 3–6 units of wine/wk had an 11% lower risk of H. pylori infection compared with those who took no wine: OR = 0.89, 95% CI = 0.80–0.99. Higher wine consumption was associated with a further 6% reduction in the risk of infection: OR = 0.83, 95% CI = 0.64–1.07. Intake of 3–6 units of beer (but no greater intake) was associated with a similar reduction in the risk of infection when compared to no beer intake (OR = 0.83, 95% CI = 0.75–0.91).CONCLUSIONS:This study indicates that modest consumption of wine and beer (approximately 7 units/wk) protects against H. pylori infection, presumably by facilitating eradication of the organism.

Genetic Variants in the Vitamin D Receptor Are Associated with Advanced Prostate Cancer at Diagnosis: Findings from the Prostate Testing for Cancer and Treatment Study and a Systematic Review

Low levels of plasma vitamin D have been implicated as a possible risk factor for both prostate cancer incidence and advanced disease, and recent phase II trials suggest that vitamin D supplementation might delay progression of prostate cancer. Common polymorphisms in the vitamin D receptor (VDR) are associated with VDR activity and are therefore potentially useful proxies for assessing whether vitamin D is causally related to advanced prostate cancer. We genotyped five well-known VDR polymorphisms in 1,604 men with prostate cancer from the Prostate Testing for Cancer and Treatment study. Our aim was to examine the association between VDR polymorphisms and cancer stage (localized versus advanced) as well as cancer grade (Gleason score <7 versus ≥7). Moreover, we also carried out a systematic review and meta-analysis of 13 similar studies. As a result of our meta-analysis, we revealed three polymorphisms, BsmI, ApaI, and TaqI, associated with high Gleason score with an overall summary odds ratios (95% confidence intervals) of 1.12 (1.00-1.25; bb versus BB + Bb), 1.25 (1.02-1.53; aa versus AA + Aa), and 0.82 (0.69-0.98; Tt + tt versus TT), respectively. The haplotype analysis revealed that the BsmI (B)-ApaI (A)-TaqI (t) participants compared with BsmI (b)-ApaI (a)-TaqI (T) individuals were less likely to have high Gleason scores (odds ratio, 0.84; 95% confidence interval, 0.71-1.00; Punadjusted = 0.050; Padjusted = 0.014). Our finding provides some support for the hypothesis that low levels of vitamin D may increase the risk of prostate cancer progression. (Cancer Epidemiol Biomarkers Prev 2009;18(11):2874–81)

Increased population prevalence of reflux and obesity in the United Kingdom compared with Sweden: a potential explanation for the difference in incidence of esophageal adenocarcinoma.

Objectives The incidence of esophageal adenocarcinoma is five times higher in the UK than in Sweden. We examined the prevalence of established risk factors for esophageal adenocarcinoma in both populations. Methods A population-based cross-sectional study comparing the prevalence of gastroesophageal reflux symptoms, obesity, and tobacco smoking between random samples of the English and Swedish populations aged 40–59 years. Data were collected through self-report questionnaires. Multivariable logistic regression yielded odds ratios with 95% confidence intervals, adjusting for potential confounding. Results The sample was composed of 3633 English and 1483 Swedish people (response rates 43 and 62%, respectively). The prevalence of reflux symptoms occurring at least weekly was twice as common in the English compared with the Swedish sample. Obesity (BMI ≥30) was also nearly two-fold more common in the English sample. The frequency of tobacco smoking was similar in both countries. The combination of reflux symptoms and a BMI of at least 25 was three-fold more common in the English than in the Swedish sample. Conclusion The substantially higher prevalence of reflux symptoms and obesity in samples of the English population compared with the Swedish population might contribute to the known higher incidence of esophageal adenocarcinoma in the UK.

Effect of Helicobacter pylori infection on blood pressure: a community based cross sectional study

Many studies have reported an association between Helicobacter pylori infection and an increased risk of cardiovascular disease. The strength of the association has been hard to judge because of the varied methods of the studies and substantial heterogeneity of the findings. Mechanisms that may contribute to this association include abnormalities in the levels of certain blood proteins (for example fibrinogen or C reactive protein) secondary to the chronic infection 1 2 and raised blood pressure in people infected with H pylori .3–5 There are several methodological difficulties in carrying out studies to determine whether H pylori infection results in raised blood pressure. We have attempted to minimise such problems in a large prospective community based study of the association between H pylori infection and blood pressure. The Bristol helicobacter project is a community based study centred on the northeastern suburbs of Bristol. The primary aims of the study are to assess the …

Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life

To present the baseline patient‐reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external‐beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.

The importance of dietary change for men diagnosed with and at risk of prostate cancer: a multi-centre interview study with men, their partners and health professionals

BackgroundThe diagnosis of prostate cancer (PC) can provide a trigger for dietary change, and there is evidence that healthier diets may improve quality of life and clinical outcomes. However, men’s views about dietary change in PC survivorship are largely unknown. This multi-centre qualitative interview study explored men’s views about dietary change in PC survivorship, to better understand motivations for, and barriers to, achieving desired changes. The role of radical and active surveillance treatments on dietary change and the influence of men’s partners were examined. Focus groups also evaluated stakeholder opinion, including healthcare professionals, about the provision of dietary advice to PC patients.MethodsA multi-centre interview study explored views about diet and motivations for, and barriers to, dietary change in men at elevated risk or diagnosed with PC following prostate specific antigen (PSA) testing. 58 men and 11 partners were interviewed. Interviews and focus groups were undertaken with 11 healthcare professionals, 5 patients and 4 partners to evaluate stakeholders’ opinions about the feasibility and acceptability of providing dietary advice to PC patients. Data were analysed using methods of constant comparison and thematic analysis.ResultsOver half of diagnosed men reported making dietary changes, primarily to promote general or prostate health or facilitate coping, despite their uncertainty about diet-PC links. Interest in dietary advice was high. Information needs varied depending on treatment received, with men on active surveillance more frequently modifying their diet and regarding this as an adjunct therapy. Men considered their partners integral to implementing changes. Provision of dietary advice to men diagnosed with PC was considered by healthcare professionals and men to be feasible and appropriate in the context of a holistic ‘care package’.ConclusionsMany men make positive dietary changes after PC diagnosis, which are perceived by men and their partners to bring psychological and general health benefits and could help future dietary intervention trials. Men and their partners desire more and better dietary information that may support PC survivorship, particularly among those embarking on active surveillance/monitoring programmes. There are opportunities for healthcare professionals to support PC patients both clinically and psychologically by the routine integration of healthy eating advice into survivorship care plans.

Feasibility and cost of obtaining informed consent for essential review of medical records in large-scale health services research

Objective: To evaluate the effectiveness and cost of obtaining consent for review of medical records within the passively observed non-intervention arm of a cluster randomized controlled trial, ‘Comparison Arm for ProtecT’. Methods: Two hundred and thirty men, who had been notified to the trial by cancer registries as having prostate cancer, were sent a consent form from their general practitioner or secondary care clinician. The consent rate of participants to the review of their medical records and the estimated costs of the process were evaluated. Results: One hundred and seventy-nine men (84%: 95% CI = 78%, 89%) consented to have their medical notes reviewed at an estimated cost of £123 (€172,

Evaluating best practice in informed consent discussions: a new method of evaluating information provision and patient understanding during trial recruitment consultations

248) per person. Conclusions: A high consent rate for review of medical notes is achievable but at a cost. There needs to be renewed debate about the automatic need for consent to review medical records where the chance of personal harm is negligible and the purpose of the review is to provide robust evidence to save lives, prevent needless suffering, and improve the effectiveness and efficiency of health care delivery.

The Rationale and Design of the Reducing Pathology in Alzheimer's Disease through Angiotensin TaRgeting (RADAR) Trial

Background Use of discussion and questioning is an effective supplement to written information provision during trial recruitment. Current evaluations of recruitment consultations monitor information delivered by recruiters, ignoring evidence of patient understanding/misunderstanding. This study a) developed a method of evaluating the quality of information provision and understanding during informed consent consultations for RCT recruitment (QUICC-RCT) that took patient responses into account and b) investigated the feasibility of applying it as a tool to evaluate informed consent (IC) in recruitment consultations.

Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience

BACKGROUND Anti-hypertensives that modify the renin angiotensin system may reduce Alzheimers disease (AD) pathology and reduce the rate of disease progression. OBJECTIVE To conduct a phase II, two arm, double-blind, placebo-controlled, randomized trial of losartan to test the efficacy of Reducing pathology in Alzheimers Disease through Angiotensin TaRgeting (RADAR). METHODS Men and women aged at least 55 years with mild-to-moderate AD will be randomly allocated 100 mg encapsulated generic losartan or placebo once daily for 12 months after successful completion of a 2-week open-label phase and 2-week placebo washout to establish drug tolerability. 228 participants will provide at least 182 subjects with final assessments to provide 84% power to detect a 25% difference in atrophy rate (therapeutic benefit) change over 12 months at an alpha level of 0.05. We will use intention-to-treat analysis, estimating between-group differences in outcomes derived from appropriate (linear or logistic) multivariable regression models adjusting for minimization variables. RESULTS The primary outcome will be rate of whole brain atrophy as a surrogate measure of disease progression. Secondary outcomes will include changes to 1) white matter hyperintensity volume and cerebral blood flow; 2) performance on a standard series of assessments of memory, cognitive function, activities of daily living, and quality of life. Major assessments (for all outcomes) and relevant safety monitoring of blood pressure and bloods will be at baseline and 12 months. Additional cognitive assessment will also be conducted at 6 months along with safety blood pressure and blood monitoring. Monitoring of blood pressure, bloods, and self-reported side effects will occur during the open-label phase and during the majority of the post-randomization dispensing visits. CONCLUSION This study will identify whether losartan is efficacious in the treatment of AD and whether definitive Phase III trials are warranted.