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1.  Health on the Web: Randomised Controlled Trial of Online Screening and Brief Alcohol Intervention Delivered in a Workplace Setting 
PLoS ONE  2014;9(11):e112553.
Background
Alcohol misuse in England costs around £7.3 billion (US$12.2 billion) annually from lost productivity and absenteeism. Delivering brief alcohol interventions to employees as part of a health check may be acceptable, particularly with online delivery which can provide privacy for this stigmatised behaviour. Research to support this approach is limited and methodologically weak. The aim was to determine the effectiveness of online screening and personalised feedback on alcohol consumption, delivered in a workplace as part of a health check.
Methods and Findings
This two-group online individually randomised controlled trial recruited employees from a UK-based private sector organisation (approx. 100,000 employees). 3,375 employees completed the online health check in the three week recruitment period. Of these, 1,330 (39%) scored five or more on the AUDIT-C (indicating alcohol misuse) and were randomised to receive personalised feedback on their alcohol intake, alongside feedback on other health behaviours (n = 659), or to receive feedback on all health behaviours except alcohol intake (n = 671). Participants were mostly male (75%), with a median age of 48 years and half were in managerial positions (55%). Median Body Mass Index was 26, 12% were smokers, median time undertaking moderate/vigorous physical activity a week was 173 minutes and median fruit and vegetable consumption was three portions a day. Eighty percent (n = 1,066) of participants completed follow-up questionnaires at three months. An intention to treat analysis found no difference between experimental groups for past week drinking (primary outcome) (5.6% increase associated with the intervention (95% CI −4.7% to 16.9%; p = .30)), AUDIT (measure of alcohol-related harm) and health utility (EQ-5D).
Conclusions
There was no evidence to support the use of personalised feedback within an online health check for reducing alcohol consumption among employees in this organisation. Further research is needed on how to engage a larger proportion of employees in screening.
Trial Registration
International Standard Randomised Controlled Trial Number Register ISRCTN50658915
doi:10.1371/journal.pone.0112553
PMCID: PMC4237335  PMID: 25409454
2.  Beta-blockers for heart failure 
This is the protocol for a review and there is no abstract. The objectives are as follows:
Our objective is to appraise the effectiveness of beta blockers in patients with heart failure. Our protocol defined main outcome is all cause mortality. The specific a priori defined aims are to examine: the effectiveness of beta blockers in all trials of patients with heart failure, and examine the importance of the presence or absence of ischaemic cardiomyopathy in patients included in trials and vasodilator properties of beta blocking agents used. We will also examine the predictive value of left ventricular function, age, use of angiotensin converting enzyme inhibitors and New York Heart Association Class (NYHA), and the rate of discontinuation of therapy due to treatment.
There are a number of important ongoing trials for which data will become available in the next few years. Thus a systematic review which may be updated regularly is required to provide an up to date synthesis of the available data in this increasingly important area.
doi:10.1002/14651858.CD002131
PMCID: PMC4234084  PMID: 25411555
5.  Surgeon length of service and risk-adjusted outcomes: linked observational analysis of the UK National Adult Cardiac Surgery Audit Registry and General Medical Council Register 
Summary
Objectives
To explore the relationship between in-hospital mortality following adult cardiac surgery and the time since primary clinical qualification for the responsible consultant cardiac surgeon (a proxy for experience).
Design
Retrospective analysis of prospectively collected national registry data over a 10-year period using mixed-effects multiple logistic regression modelling. Surgeon experience was defined as the time between the date of surgery and award of primary clinical qualification.
Setting
UK National Health Service hospitals performing cardiac surgery between January 2003 and December 2012.
Participants
All patients undergoing coronary artery bypass grafts and/or valve surgery under the care of a consultant cardiac surgeon.
Main outcome measures
All-cause in-hospital mortality.
Results
A total of 292,973 operations performed by 273 consultant surgeons (with lengths of service from 11.2 to 42.0 years) were included. Crude mortality increased approximately linearly until 33 years service, before decreasing. After adjusting for case-mix and year of surgery, there remained a statistically significant (p = 0.002) association between length of service and in-hospital mortality (odds ratio 1.013; 95% CI 1.005–1.021 for each year of ‘experience’).
Conclusions
Consultant cardiac surgeons take on increasingly complex surgery as they gain experience. With this progression, the incidence of adverse outcomes is expected to increase, as is demonstrated in this study. After adjusting for case-mix using the EuroSCORE, we observed an increased risk of mortality in patients operated on by longer serving surgeons. This finding may reflect under-adjustment for risk, unmeasured confounding or a real association. Further research into outcomes over the time course of surgeon's careers is required.
doi:10.1177/0141076814538788
PMCID: PMC4206624  PMID: 25193057
clinical experience; length of service; clinical performance; General Medical Council register; cardiac surgery; audit
6.  A pilot study to assess the feasibility and impact of a brief motivational intervention on problem drug and alcohol use in adult mental health inpatient units: study protocol for a randomized controlled trial 
Trials  2014;15(1):308.
Background
Substance misuse in those with severe mental health problems is common and associated with poor engagement in treatment and treatment outcomes. Up to 44% of those admitted into psychiatric inpatient facilities have coexisting substance-misuse problems. However, this is not routinely addressed as part of their treatment plan. A mental health admission may present a window of opportunity for inpatients to reevaluate the impact of their substance use. This study will aim to evaluate the effectiveness of a targeted brief motivational intervention in improving engagement in treatment and to assess how feasible and acceptable this intervention is to inpatients and staff as a routine intervention.
Methods/Design
This randomized controlled trial will use concealed randomization; blind, independent assessment of outcome at 3 months; characterization of refusers and dropouts; and be analyzed according to the intention-to-treat principle. After baseline assessments, eligible participants will be randomized either to the Brief Integrated Motivational Intervention plus Treatment As Usual, or Treatment as Usual alone. Eligible participants will be those who are new admissions; >18 years; ICD-10 diagnosis of -schizophrenia or related disorder, bipolar affective disorder, recurrent depressive disorder, and DSM-IV diagnosis of substance abuse or dependence over the last 3 months. The primary outcome is engagement in treatment for substance misuse, and secondary outcomes include readiness to change substance misuse together with a cost-effectiveness analysis. Qualitative interviews with staff and participants will assess the acceptability of the intervention.
Discussion
This pilot randomized trial will provide the first robust evidence base for inpatient care of people with severe mental health problems and co-morbid substance misuse and provide the groundwork for confirmatory trials to evaluate a potentially feasible, cost-effective, and easy-to-implement treatment option that may be readily integrated into standard inpatient and community-based care.
Trial registration
ISRCTN43548483 Date of ISRCTN assignation: 4/17/2014.
doi:10.1186/1745-6215-15-308
PMCID: PMC4124140  PMID: 25085539
Inpatient; Comorbid; intervention; Brief motivational intervention; Treatment; Randomized controlled trial; Dual diagnosis; Substance misuse; Severe mental health condition; Schizophrenia; Psychiatric hospital admission
8.  Ophthalmic statistics note 1: unit of analysis 
doi:10.1136/bjophthalmol-2013-304587
PMCID: PMC4107464  PMID: 24357496
Epidemiology; Medical Education
9.  Gender Differences in Survival and the Use of Primary Care Prior to Diagnosis of Three Cancers: An Analysis of Routinely Collected UK General Practice Data 
PLoS ONE  2014;9(7):e101562.
Objective
To explore whether there are gender differences in the number of GP recorded cases, the probability of survival and consulting pattern prior to diagnosis amongst patients with three non-sex-specific cancers.
Design
Cross sectional study.
Setting
UK primary care.
Subjects
12,189 patients aged 16 years or over diagnosed with colorectal cancer (CRC), 11,081 patients with lung cancer and 4,352 patients with malignant melanoma, with first record of cancer diagnosis during 1997–2006.
Main outcome measures
Cancer cases recorded in primary care; probability of survival following diagnosis; and number of GP contacts within the 24 months preceding diagnosis.
Results
From 1997–2006, overall rates of GP recorded CRC and lung cancer cases recorded were higher in men than in women, but rates of malignant melanoma were higher in women than in men. Gender differences in survival were small; 49% of men and 53% of women survived at least 5 years following CRC diagnosis; 9% of men and 12% of women with lung cancer, and 77% of men and 86% of women with malignant melanoma. The adjusted male to female relative hazard ratio of death in all patients was 1.20 (95%CI 1.13–1.30), 1.24 (95%CI 1.16–1.33) and 1.73 (95%CI 1.51–2.00) for CRC, lung cancer and malignant melanoma respectively. However, gender differences in the relative risk were much smaller amongst those who died during follow-up. For each cancer, there was little evidence of gender difference in the percentage who consulted and the number of GP contacts made within 24 months prior to diagnosis.
Conclusions
This study found that patterns of consulting prior to cancer diagnosis differed little between two genders, providing no support for the hypothesis that gender differences in survival are explained by gender differences in consultation for more serious illness, and suggests the need for a more critical view of gender and consultation.
doi:10.1371/journal.pone.0101562
PMCID: PMC4094390  PMID: 25014510
10.  Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial 
Trials  2014;15:158.
Background
Chronic kidney disease is associated with increased arterial stiffness even in the early stages and this is thought to be a key mediator in the pathophysiology of the increased cardiovascular risk associated with this condition. The use of low-dose spironolactone has previously been shown to improve arterial stiffness and reduce left ventricular mass safely in early-stage chronic kidney disease in the context of careful monitoring at a university hospital. However, the majority of patients with chronic kidney disease are managed by their general practitioners in the community. It is not known whether similar beneficial effects can be achieved safely using spironolactone in the primary care setting. The aim of this study is to determine whether low-dose spironolactone can safely lower arterial stiffness in patients with stage 3 chronic kidney disease in the primary care setting.
Methods/design
STOP-CKD is a multicentre, prospective, randomized, double-blind, placebo-controlled pilot trial of 240 adult patients with stage 3 chronic kidney disease recruited from up to 20 general practices in South Birmingham, England. Participants will be randomly allocated using a secured web-based computer randomization system to receive either spironolactone 25 mg once daily or a matching inactive placebo for 40 weeks, followed by a wash-out period of 6 weeks. Investigators, outcome assessors, data analysts and participants will all be blinded to the treatment allocation. The primary endpoint is improved arterial stiffness, as measured by carotid-femoral pulse wave velocity between baseline and 40 weeks. The secondary endpoints are incidence of hyperkalaemia, change in estimated glomerular filtration rate, change in urine albumin:creatinine ratio, change in brachial blood pressure, change in pulse waveform characteristics and overall tolerability of spironolactone. An additional quality control study, aiming to compare the laboratory serum potassium results of samples processed via two methods (utilizing routine transport or centrifugation on site before rapid transport to the laboratory) for 100 participants and a qualitative research study exploring patients’ and general practitioners’ attitudes to research and the use of spironolactone in chronic kidney disease in the community setting will be embedded in this pilot study.
Trial registration
Current Controlled Trials ISRCTN80658312.
doi:10.1186/1745-6215-15-158
PMCID: PMC4113230  PMID: 24886272
arterial stiffness; cardiovascular events; chronic kidney disease; feasibility; mineralocorticoid receptor antagonist; pulse wave velocity; qualitative; randomized controlled trial; renal dysfunction; spironolactone
11.  Understanding Patients’ Adherence-Related Beliefs about Medicines Prescribed for Long-Term Conditions: A Meta-Analytic Review of the Necessity-Concerns Framework 
PLoS ONE  2013;8(12):e80633.
Background
Patients’ beliefs about treatment influence treatment engagement and adherence. The Necessity-Concerns Framework postulates that adherence is influenced by implicit judgements of personal need for the treatment (necessity beliefs) and concerns about the potential adverse consequences of taking it.
Objective
To assess the utility of the NCF in explaining nonadherence to prescribed medicines.
Data sources
We searched EMBASE, Medline, PsycInfo, CDSR/DARE/CCT and CINAHL from January 1999 to April 2013 and handsearched reference sections from relevant articles.
Study eligibility criteria
Studies using the Beliefs about Medicines Questionnaire (BMQ) to examine perceptions of personal necessity for medication and concerns about potential adverse effects, in relation to a measure of adherence to medication.
Participants
Patients with long-term conditions.
Study appraisal and synthesis methods
Systematic review and meta-analysis of methodological quality was assessed by two independent reviewers. We pooled odds ratios for adherence using random effects models.
Results
We identified 3777 studies, of which 94 (N = 25,072) fulfilled the inclusion criteria. Across studies, higher adherence was associated with stronger perceptions of necessity of treatment, OR = 1.742, 95% CI [1.569, 1.934], p<0.0001, and fewer Concerns about treatment, OR = 0.504, 95% CI: [0.450, 0.564], p<0.0001. These relationships remained significant when data were stratified by study size, the country in which the research was conducted and the type of adherence measure used.
Limitations
Few prospective longitudinal studies using objective adherence measures were identified.
Conclusions
The Necessity-Concerns Framework is a useful conceptual model for understanding patients’ perspectives on prescribed medicines. Taking account of patients’ necessity beliefs and concerns could enhance the quality of prescribing by helping clinicians to engage patients in treatment decisions and support optimal adherence to appropriate prescriptions.
doi:10.1371/journal.pone.0080633
PMCID: PMC3846635  PMID: 24312488
12.  Use of Primary Care Data for Detecting Impetigo Trends, United Kingdom, 1995–2010 
Emerging Infectious Diseases  2013;19(10):1646-1648.
Using a primary care database, we identified a major increase in impetigo in the United Kingdom during 1995–2010. Despite a doubled rate of primary care consultations, this increase was not identified by routine surveillance. Primary care databases are a valuable and underused source of surveillance data on infectious diseases.
doi:10.3201/eid1910.130433
PMCID: PMC3810750  PMID: 24047615
impetigo; epidemiology; Staphylococcus aureus; primary care; United Kingdom; bacteria
13.  Do men consult less than women? An analysis of routinely collected UK general practice data 
BMJ Open  2013;3(8):e003320.
Objective
To examine whether gender differences in primary care consultation rates (1) vary by age and deprivation status and (2) diminish when consultation for reproductive reasons or common underlying morbidities are accounted for.
Design
Cross-sectional study of a cohort of patients registered with general practice.
Setting
UK primary care.
Subjects
Patients (1 869 149 men and 1 916 898 women) registered with 446 eligible practices in 2010.
Primary outcome measures
Primary care consultation rate.
Results
This study analyses routinely collected primary care consultation data. The crude consultation rate was 32% lower in men than women. The magnitude of gender difference varied across the life course, and there was no ‘excess’ female consulting in early and later life. The greatest gender gap in primary care consultations was seen among those aged between 16 and 60 years. Gender differences in consulting were higher in people from more deprived areas than among those from more affluent areas. Accounting for reproductive-related consultations diminished but did not eradicate the gender gap. However, consultation rates in men and women who had comparable underlying morbidities (as assessed by receipt of medication) were similar; men in receipt of antidepressant medication were only 8% less likely to consult than women in receipt of antidepressant medication (relative risk (RR) 0.916, 95% CI 0.913 to 0.918), and men in receipt of medication to treat cardiovascular disease were just 5% less likely to consult (RR=0.950, 95% CI 0.948 to 0.952) than women receiving similar medication. These small gender differences diminished further, particularly for depression (RR=0.950, 95% CI 0.947 to 0.953), after also taking account of reproductive consultations.
Conclusions
Overall gender differences in consulting are most marked between the ages of 16 and 60 years; these differences are only partially accounted for by consultations for reproductive reasons. Differences in consultation rates between men and women were largely eradicated when comparing men and women in receipt of medication for similar underlying morbidities.
doi:10.1136/bmjopen-2013-003320
PMCID: PMC3753483  PMID: 23959757
Primary Care; Health Services Administration & Management; Epidemiology; Social Medicine
14.  Health on the web: randomised trial of work-based online screening and brief intervention for hazardous and harmful drinking 
BMC Public Health  2013;13:505.
Background
Alcohol misuse is a significant international public health problem. Screening and brief intervention (SBI) in primary care reduces alcohol consumption by about 15 – 30%, sustained over 12 months in hazardous or harmful drinkers but implementation has proved difficult leading to growing interest in exploring the effectiveness of SBI in other settings, including the workplace. Computerised interventions for alcohol misuse can be as effective as traditional face-to-face interventions and may have advantages, including anonymity, convenience and availability.
Methods/design
Individually randomised controlled trial to determine the effectiveness and cost-effectiveness of offering online screening and brief intervention for alcohol misuse in a workplace. Participants: adults (aged 18 or over) employed by participating employers scoring 5 or more on a three item screen for alcohol misuse (the AUDIT-C) indicating possible hazardous or harmful alcohol consumption, recruited through the offer of an online health check providing screening for a range of health behaviours with personalised feedback. Participants who accept the health check and score 5 or more on the alcohol screen will be randomised to receiving immediate feedback on their alcohol consumption and access to an online intervention offering support in reducing alcohol consumption (Down Your Drink) or delayed feedback and access to Down Your Drink after completion of follow-up data at three months. All employees who take the online health check will receive personalised feedback on other screened health behaviours including diet, physical activity, smoking, and body mass index. The primary outcome is alcohol consumption in the past week at three months; secondary outcomes are the AUDIT, EQ-5D, days off work, number and duration of hospital admissions, costs and use of the intervention. A sample size of 1,472 participants (736 in each arm) provides 90% power with 5% significance to determine a 20% reduction in alcohol consumption. Outcomes between groups at three months will be compared following the intention to treat principle and economic analyses will follow NICE guidance.
Discussion
This innovative design avoids recruitment bias by not mentioning alcohol in the invitation and avoids reactivity of assessment by not collecting baseline data on alcohol consumption.
doi:10.1186/1471-2458-13-505
PMCID: PMC3671166  PMID: 23706155
Alcohol-related disorders; Alcohol; Screening and brief intervention; Internet; Randomised; Controlled trial; Workplace; Health promotion
15.  Don’t turn your back on the symptoms of psychosis: a proof-of-principle, quasi-experimental public health trial to reduce the duration of untreated psychosis in Birmingham, UK 
BMC Psychiatry  2013;13:67.
Background
Reducing the duration of untreated psychosis (DUP) is an aspiration of international guidelines for first episode psychosis; however, public health initiatives have met with mixed results. Systematic reviews suggest that greater focus on the sources of delay within care pathways, (which will vary between healthcare settings) is needed to achieve sustainable reductions in DUP (BJP 198: 256-263; 2011).
Methods/Design
A quasi-experimental trial, comparing a targeted intervention area with a ‘detection as usual’ area in the same city. A proof-of–principle trial, no a priori assumptions are made regarding effect size; key outcome will be an estimate of the potential effect size for a definitive trial. DUP and number of new cases will be collected over an 18-month period in target and control areas and compared; historical data on DUP collected in both areas over the previous three years, will serve as a benchmark. The intervention will focus on reducing two significant DUP component delays within the overall care pathway: delays within the mental health service and help-seeking delay.
Discussion
This pragmatic trial will be the first to target known delays within the care pathway for those with a first episode of psychosis. If successful, this will provide a generalizable methodology that can be implemented in a variety of healthcare contexts with differing sources of delay.
Trial registration
http://www.controlled-trials.com/ISRCTN45058713
doi:10.1186/1471-244X-13-67
PMCID: PMC3599688  PMID: 23432935
Public mental health campaign; First-episode psychosis; Early detection; Duration of untreated psychosis; Youth mental health
16.  A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR-FVG): the study protocol 
BMJ Open  2013;3(2):e002304.
Introduction
There is a strong body of evidence demonstrating the effectiveness of brief interventions by primary care professionals for risky drinkers. However, implementation levels remain low because of time constraints and other factors. Facilitated access to an alcohol reduction website offers primary care professionals a time-saving alternative to standard face-to-face intervention, but it is not known whether it is as effective.
Methods and analysis
A randomised controlled non-inferiority trial for risky drinkers comparing facilitated access to a dedicated website with standard face-to-face brief intervention to be conducted in primary care settings in the Region of Friuli Giulia Venezia, Italy. Adult patients will be given a leaflet inviting them to log on to a website to complete the Alcohol Use Disorders Identification Test (AUDIT-C) alcohol screening questionnaire. Screen positives will be requested to complete an online trial module including consent, baseline assessment and randomisation to either standard intervention by the practitioner or facilitated access to an alcohol reduction website. Follow-up assessment of risky drinking will be undertaken online at 1 month, 3 months and 1 year using the full AUDIT questionnaire. Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of 10%. Assuming a reduction of 30% of risky drinkers receiving standard intervention, 1000 patients will be required to give 90% power to reject the null hypothesis.
Ethics and dissemination
The protocol was approved by the Isontina Independent Local Ethics Committee on 14 June 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident.
Registration details
Trial registration number NCT: 01638338.
doi:10.1136/bmjopen-2012-002304
PMCID: PMC3586130  PMID: 23408073
Health Promotion
17.  Can we update the Summary Hospital Mortality Index (SHMI) to make a useful measure of the quality of hospital care? An observational study 
BMJ Open  2013;3(1):e002018.
Objective
To advance methods for the estimation of hospital performance based upon mortality ratios.
Design
Observational study estimating trust performance in a year derived according to comparative standards from a 3-year period, accounting for patient-level case-mix and overdispersion (unexplained variability).
Participants
23 363 630 admissions to the English National Health Service (NHS) by NHS Trust.
Main outcome measures
Number of SDs (QUality and Outcomes Research Unit Measure, QUORUM banding) and comparative odds of hospital mortality difference from mean performance by trust compared for 2010/2011, 2008/2009 and 2009/2010, accounting for patient-level case-mix.
Results
The model was highly predictive of mortality (C statistic=0.93), and well calibrated by risk stratum. There was substantial overdispersion. No trusts were more than 3 SDs above the mean, and only one trust was more than 2 SDs above the mean for 2010/2011.
Conclusions
QUORUM is highly predictive of patient mortality in hospital or up to 30 days after admission. However, like the Summary Hospital Mortality Indicator (SHMI), QUORUM is subjected to considerable remaining legitimate but unexplained variation. It is unlikely that measures like QUORUM and SHMI will be useful beyond identifying a very small number of trusts as potential outliers.
doi:10.1136/bmjopen-2012-002018
PMCID: PMC3563139  PMID: 23370014
Public Health; Education & Training (See Medical Education & Training); Epidemiology
20.  Variation in Recorded Child Maltreatment Concerns in UK Primary Care Records: A Cohort Study Using The Health Improvement Network (THIN) Database 
PLoS ONE  2012;7(11):e49808.
Objectives
To determine variation over time and between practices in recording of concerns related to abuse and neglect (maltreatment) in children's primary care records.
Design
Retrospective cohort study using a United Kingdom representative primary care database.
Setting
448 General Practices.
Participants
In total 1,548, 972 children (<18 y) registered between 1995 and 2010.
Main Outcome Measures
Change in annual incidence of one or more maltreatment-related codes per child year of registration. Variation between general practices measured as the proportion of registered children with one or more maltreatment-related codes during 3 years (2008–2010).
Results
From 1995–2010, annual incidence rates of any coded maltreatment-related concerns rose by 10.8% each year (95% confidence interval 10.5, 11.2; adjusted for sex, age and deprivation). In 2010 the rate was 9.5 per 1000 child years (95%CI: 9.3, 9.8), equivalent to a prevalence of 0.8% of all registered children in 2010. Across all practices, the median prevalence of children with any maltreatment-related codes in three years (2008 to 2010) was 0.9% (range 0%–13.4%; 11 practices (2.5%) had zero children with relevant codes in the same period). Once we accounted for sex, age, and deprivation, the prevalence for each practice was within two standard errors of the grand mean.
Conclusions
General Practitioners (GPs) are far from disengaged from safeguarding children; they are consistently and increasingly recording maltreatment concerns. As these results are likely to underestimate the burden of maltreatment known to primary care, there is much scope for increasing recording in primary care records with implications for resources to respond to concerns about maltreatment. Interventions and policies should build on this evidence that the average GP in the UK is engaged in child safeguarding activity.
doi:10.1371/journal.pone.0049808
PMCID: PMC3509120  PMID: 23209604
21.  Cardiovascular Outcomes in the AFFIRM Trial: An Assessment of Individual Antiarrhythmic Drug Therapies compared to Rate Control Using Propensity Score Matched Analyses 
Objective
The impact of individual antiarrhythmic drugs (AADs) on mortality and hospitalization in atrial fibrillation (AF) was evaluated
Background
Cardiovascular (CV) outcomes in AF patients on pharmacologic rhythm control therapy have not been compared with rate control therapy based on AAD selection.
Methods
We compared CV outcomes in the AFFIRM trial in subgroups defined by the initial AAD selected with propensity score matched subgroups from the rate arm (Rate).
Results
729 amiodarone patients, 606 sotalol patients & 268 class 1C patients were matched. The composite outcome of mortality or CV hospitalizations (CVH) showed better outcomes with Rate compared to amiodarone (Hazard Ratio [HR] 1.18, 95% confidence intervals {CI}:1.03–1.36, p=0.02), sotalol (HR=1.32, CI: 1.13–1.54, p<0.001) and class 1C (HR=1.22, CI: 0.97–1.56, p=0.10). There was a non-significant increase in mortality with amiodarone (HR=1.20, CI: 0.94–1.53, p=0.15) with the risk of non-CV death, being significantly higher with amiodarone versus Rate. (HR=1.11, CI: 1.01–1.24, p=0.04). First CVH event rates at 3 years were 47% for amiodarone, 50% for sotalol and 44% for class 1C versus 40%, 40% and 36% respectively for Rate (amiodarone HR=1.20,CI:1.03–1.40,p=0.02, sotalol HR=1.364, CI:1.16–1.611, p<0.001, class 1C HR=1.24,CI:0.96–1.60,p=0.09). Time to CVH with intensive care unit stay (ICUH) or death was shorter with amiodarone (HR=1.22, CI: 1.02–1.46, p=0.03).
Conclusions
In AFFIRM, composite mortality and CVH outcomes differed for Rate and AADs due to differences in CVH; CVH event rates during follow-up were high for all cohorts, but they were higher for all groups on AADs.Death, ICUH and non-CV death were more frequent with amiodarone.
doi:10.1016/j.jacc.2011.07.036
PMCID: PMC3290399  PMID: 22032709
Atrial Fibrillation; Outcomes Research; Antiarrhythmic Drugs; Clinical Trials; Cardiovascular Outcomes; Cardiovascular Hospitalizations
22.  Trends in consultant clinical activity and the effect of the 2003 contract change: retrospective analysis of secondary data 
Objectives
To explore trends in the clinical activity of hospital specialists in English National Health Service (NHS) hospitals, and test the effect of contract reform.
Design
Retrospective secondary analysis of hospital episode statistics, describing trends and testing for a contract effect using multilevel interrupted time series analysis.
Setting
Ten surgical and medical specialties in English NHS hospitals from 1999 to 2009.
Participants
Hospital consultants on full time or maximum part-time English NHS hospitals.
Intervention
A new contract offered to NHS consultants in October 2003, with higher pay alongside job planning and appraisal.
Main outcome measures
Inpatient finished consultant episodes (FCEs) per consultant per month, with and without accounting for case-mix differences.
Results
In most specialties there was a statistically significant downward trend in FCEs per consultant per month. On average in the surgical specialties, FCEs reduced by 0.14 per month (95% CI −0.16 to −0.11) and in medicine there was a smaller reduction of 0.08 FCEs per month (95% CI −0.1 to −0.06). NHS patients symptoms have increased in severity over time, and the downward trend is reduced after case-mix-adjustment, and reversed in general and geriatric medicine. The effect of the contract on clinical activity was minimal. In five specialties there was no statistically significant effect, but in five specialties there was a statistically significant negative effect.
Conclusions
Consultant clinical activity, as measured by FCEs per month, has shown a general downward trend from 1999 to 2009. The consultant contract was not associated with an increase in consultant clinical activity rates.
doi:10.1258/jrsm.2012.120130
PMCID: PMC3526852  PMID: 23239240
23.  Designing an intervention to help people with colorectal adenomas reduce their intake of red and processed meat and increase their levels of physical activity: a qualitative study 
BMC Cancer  2012;12:255.
Background
Most cases of colorectal cancer (CRC) arise from adenomatous polyps and malignant potential is greatest in high risk adenomas. There is convincing observational evidence that red and processed meat increase the risk of CRC and that higher levels of physical activity reduce the risk. However, no definitive randomised trial has demonstrated the benefit of behaviour change on reducing polyp recurrence and no consistent advice is currently offered to minimise patient risk. This qualitative study aimed to assess patients’ preferences for dietary and physical activity interventions and ensure their appropriate and acceptable delivery to inform a feasibility trial.
Methods
Patients aged 60–74 included in the National Health Service Bowel Cancer Screening Programme (NHSBCSP) were selected from a patient tracking database. After a positive faecal occult blood test (FOBt), all had been diagnosed with an intermediate or high risk adenoma (I/HRA) at colonoscopy between April 2008 and April 2010. Interested patients and their partners were invited to attend a focus group or interview in July 2010. A topic guide, informed by the objectives of the study, was used. A thematic analysis was conducted in which transcripts were examined to ensure that all occurrences of each theme had been accounted for and compared.
Results
Two main themes emerged from the focus groups: a) experiences of having polyps and b) changing behaviour. Participants had not associated polyp removal with colorectal cancer and most did not remember being given any information or advice relating to this at the time. Heterogeneity of existing diet and physical activity levels was noted. There was a lack of readiness to change behaviour in many people in the target population.
Conclusions
This study has confirmed and amplified recently published factors involved in developing interventions to change dietary and physical activity behaviour in this population. The need to tailor the intervention to individuals, the lack of knowledge about the aetiology of colon cancer and the lack of motivation to change behaviour are critical factors.
Trial registration
Current Controlled Trials ISRCTN03320951
doi:10.1186/1471-2407-12-255
PMCID: PMC3532076  PMID: 22708848
Adenomatous polyps; Feasibility studies; Prevention & control; Health behaviour; Attitude to health; Qualitative research; Colorectal neoplasms
24.  Population health status of South Asian and African-Caribbean communities in the United Kingdom 
Background
Population health status scores are routinely used to inform economic evaluation and evaluate the impact of disease and/or treatment on health. It is unclear whether the health status in black and minority ethnic groups are comparable to these population health status data. The aim of this study was to evaluate health-status in South Asian and African-Caribbean populations.
Methods
Cross-sectional study recruiting participants aged ≥ 45 years (September 2006 to July 2009) from 20 primary care centres in Birmingham, United Kingdom.10,902 eligible subjects were invited, 5,408 participated (49.6%). 5,354 participants had complete data (49.1%) (3442 South Asian and 1912 African-Caribbean). Health status was assessed by interview using the EuroQoL EQ-5D.
Results
The mean EQ-5D score in South Asian participants was 0.91 (standard deviation (SD) 0.18), median score 1 (interquartile range (IQR) 0.848 to 1) and in African-Caribbean participants the mean score was 0.92 (SD 0.18), median 1 (IQR 1 to 1). Compared with normative data from the UK general population, substantially fewer African-Caribbean and South Asian participants reported problems with mobility, usual activities, pain and anxiety when stratified by age resulting in higher average health status estimates than those from the UK population. Multivariable modelling showed that decreased health-related quality of life (HRQL) was associated with increased age, female gender and increased body mass index. A medical history of depression, stroke/transient ischemic attack, heart failure and arthritis were associated with substantial reductions in HRQL.
Conclusions
The reported HRQL of these minority ethnic groups was substantially higher than anticipated compared to UK normative data. Participants with chronic disease experienced significant reductions in HRQL and should be a target for health intervention.
doi:10.1186/1472-6963-12-101
PMCID: PMC3349523  PMID: 22533538
Health status; EQ-5D; South Asian; African-Caribbean
25.  Cost-effective undergraduate medical education? 
doi:10.1258/jrsm.2008.080353
PMCID: PMC2642867  PMID: 19208863

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