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

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.

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.

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.

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.

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.

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

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.

Background

Limited data exists on the prevalence of heart failure amongst minority groups in the UK. To document the community prevalence and severity of left ventricular systolic dysfunction, heart failure, and atrial fibrillation, amongst the South Asian and Black African -Caribbean groups in the UK.

Methods and Results

We conducted a cross-sectional study recruiting from September 2006 to July 2009 from 20 primary care centres in Birmingham, UK. 10,902 eligible subjects invited, 5,408 participated (49.6%) and 5,354 had complete data (49.1%). Subjects had median age 58.2 years (interquartile range 51.0 to 70.0), and 2544 (47.5%) were male. Of these, 1933 (36.3%) had BMI>30 kg/m2, 1,563 (29.2%) had diabetes, 2676 (50.0%) had hypertension, 307 (5.7%) had a history of myocardial infarction, and 104 (1.9%) had history of arrhythmia. Overall, 59 (1.1%) had an Ejection Fraction<40%, and of these 40 (0.75%) were NYHA class ≥2; 51 subjects (0.95%) had atrial fibrillation. Of the remaining 19 patients with an EF<40%, only 4 patients were treated with furosemide. A further 54 subjects had heart failure with preserved ejection fraction.

Conclusions

This is the largest study of the prevalence of left ventricular systolic dysfunction, heart failure and atrial fibrillation in under-researched minority communities in the UK. The prevalence of heart failure in these minority communities appears comparable to that of the general population but less than anticipated given the high rates of cardiovascular disease in these groups. Heart failure continues to be a major cause of morbidity in all ethnic groups and preventive strategies need to be identified and implemented.

Objective

To evaluate effectiveness of physiotherapy management in patients experiencing whiplash associated disorder II, on clinically relevant outcomes in the short and longer term.

Design

Systematic review and meta-analysis. Two reviewers independently searched information sources, assessed studies for inclusion, evaluated risk of bias and extracted data. A third reviewer mediated disagreement. Assessment of risk of bias was tabulated across included trials. Quantitative synthesis was conducted on comparable outcomes across trials with similar interventions. Meta-analyses compared effect sizes, with random effects as primary analyses.

Data sources

Predefined terms were employed to search electronic databases. Additional studies were identified from key journals, reference lists, authors and experts.

Eligibility criteria for selecting studies

Randomised controlled trials (RCTs) published in English before 31 December 2010 evaluating physiotherapy management of patients (>16 years), experiencing whiplash associated disorder II. Any physiotherapy intervention was included, when compared with other types of management, placebo/sham, or no intervention. Measurements reported on ≥1 outcome from the domains within the international classification of function, disability and health, were included.

Results

21 RCTs (2126 participants, 9 countries) were included. Interventions were categorised as active physiotherapy or a specific physiotherapy intervention. 20/21 trials were evaluated as high risk of bias and one as unclear. 1395 participants were incorporated in the meta-analyses on 12 trials. In evaluating short term outcome in the acute/sub-acute stage, there was some evidence that active physiotherapy intervention reduces pain and improves range of movement, and that a specific physiotherapy intervention may reduce pain. However, moderate/considerable heterogeneity suggested that treatments may differ in nature or effect in different trial patients. Differences between participants, interventions and trial designs limited potential meta-analyses.

Conclusions

Inconclusive evidence exists for the effectiveness of physiotherapy management for whiplash associated disorder II. There is potential benefit for improving range of movement and pain short term through active physiotherapy, and for improving pain through a specific physiotherapy intervention.

Article summary

Article focus

Physiotherapy intervention is recommended in whiplash associated disorder II, although the most beneficial intervention and the effectiveness of physiotherapy management are unclear.

Systematic reviews have not focused on whiplash associated disorder II, which represents approximately 93% of patients presenting for management post-whiplash injury.

The objective of this systematic review was to evaluate the effectiveness of physiotherapy management in patients experiencing whiplash associated disorder II, on clinically relevant outcomes in the short and longer term.

Key messages

This systematic review demonstrates inconclusive very low/low quality evidence for the effectiveness of physiotherapy management for whiplash associated disorder II.

There is potential benefit for improving pain and range of movement short term through active physiotherapy and for improving pain through specific physiotherapy interventions.

This potential benefit merits further consideration in a properly powered clinical trial with attention to ensure low risk of bias.

Strengths and limitations of this study

The strengths of this review are its focus to physiotherapy intervention and the most common whiplash associated disorder II classification requiring physiotherapy intervention.

A limitation is that differences between participants, interventions and trial designs limited potential meta-analyses.

Surprisingly, no chronic interventions were comparable for analysis, considering the high number of patients experiencing chronicity with whiplash associated disorder.

Background

With increasing globalisation, the challenges of providing accessible and safe healthcare to all are great. Studies show that there are substantial numbers of people who are not fluent in English to a level where they can make best use of health services. We examined how health professionals manage language barriers in a consultation.

Methods and Findings

This was a cross-sectional study in 41 UK general practices . Health professionals completed a proforma for a randomly allocated consultation session.

Seventy-seven (63%) practitioners responded, from 41(59%) practices. From 1008 consultations, 555 involved patients who did not have English as a first language; 710 took place in English; 222 were in other languages, the practitioner either communicating with the patient in their own language/using an alternative language. Seven consultations were in a mixture of English/patient's own language. Patients' first languages numbered 37 (apart from English), in contrast to health practitioners, who declared at least a basic level of proficiency in 22 languages other than English. The practitioner's reported proficiency in the language used was at a basic level in 24 consultations, whereas in 21, they reported having no proficiency at all. In 57 consultations, a relative/friend interpreted and in 6, a bilingual member of staff/community worker was used. Only in 6 cases was a professional interpreter booked. The main limitation was that only one random session was selected and assessment of patient/professional fluency in English was subjective.

Conclusions

It would appear that professional interpreters are under-used in relation to the need for them, with bilingual staff/family and friends being used commonly. In many cases where the patient spoke little/no English, the practitioner consulted in the patient's language but this approach was also used where reported practitioner proficiency was low. Further research in different setting is needed to substantiate these findings.

Is no substitute for evidence from randomised controlled trials

Background

Blood pressure (BP) lowering in people who have had a stroke or transient ischaemic attack (TIA) leads to reduced risk of further stroke. However, it is not clear what the target BP should be, since intensification of therapy may lead to additional adverse effects. PAST BP will determine whether more intensive BP targets can be achieved in a primary care setting, and whether more intensive therapy is associated with adverse effects on quality of life.

Methods/Design

This is a randomised controlled trial (RCT) in patients with a past history of stroke or TIA. Patients will be randomised to two groups and will either have their blood pressure (BP) lowered intensively to a target of 130 mmHg systolic, (or by 10 mmHg if the baseline systolic pressure is between 125 and 140 mmHg) compared to a standard group where the BP will be reduced to a target of 140 mmHg systolic. Patients will be managed by their practice at 1-3 month intervals depending on level of BP and followed-up by the research team at six monthly intervals for 12 months.

610 patients will be recruited from approximately 50 general practices. The following exclusion criteria will be applied: systolic BP <125 mmHg at baseline, 3 or more anti-hypertensive agents, orthostatic hypotension, diabetes mellitus with microalbuminuria or other condition requiring a lower treatment target or terminal illness.

The primary outcome will be change in systolic BP over twelve months. Secondary outcomes include quality of life, adverse events and cardiovascular events.

In-depth interviews with 30 patients and 20 health care practitioners will be undertaken to investigate patient and healthcare professionals understanding and views of BP management.

Discussion

The results of this trial will inform whether intensive blood pressure targets can be achieved in people who have had a stroke or TIA in primary care, and help determine whether or not further research is required before recommending such targets for this population.

Trial Registration

ISRCTN29062286

Background

Delays in accessing care for young people with a first episode of psychosis are significantly associated with poorer treatment response and higher relapse rates.

Aim

To assess the effect of an educational intervention for GPs on referral rates to early-intervention services and the duration of untreated psychosis for young people with first-episode psychosis.

Design of study

Stratified cluster randomised controlled trial, clustered at practice level.

Setting

Birmingham, England.

Method

Practices with access to the three early-intervention services in three inner-city primary care trusts in Birmingham were eligible for inclusion. Intervention practices received an educational intervention addressing GP knowledge, skills, and attitudes about first-episode psychosis. The primary outcome was the difference in the number of referrals to early-intervention services between practices. Secondary outcomes were duration of untreated psychosis, time to recovery, use of the Mental Health Act, and GP consultation rate during the developing illness.

Results

A total of 110 of 135 eligible practices (81%) were recruited; 179 young people were referred, 97 from intervention and 82 from control practices. The relative risk of referral was not significant: 1.20 (95% confidence interval [CI] = 0.74 to 1.95; P = 0.48). No effect was observed on secondary outcomes except for ‘delay in reaching early-intervention services’, which was statistically significantly shorter in patients registered in intervention practices (95% CI = 83.5 to 360.5; P = 0.002).

Conclusion

GP training on first-episode psychosis is insufficient to alter referral rates to early-intervention services or reduce the duration of untreated psychosis; however, there is a suggestion that training facilitates access to the new specialist teams for early psychosis.

Composite end points may mislead—and regulators allow it to happen

Summary

Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU®) is an ongoing longitudinal cohort study that utilises physician- and patient-reported measures to describe the characteristics and management of postmenopausal women on bone loss therapies. We report the study design and baseline characteristics of 3,402 women recruited from general practice across five European countries.

Purpose

The POSSIBLE EU® is a study describing the characteristics and management of postmenopausal women receiving bone loss medications.

Methods

Between 2005 and 2008, general practitioners enrolled postmenopausal women initiating, switching or continuing treatment with bone loss treatment in France, Germany, Italy, Spain and the UK. Patients and physicians completed questionnaires at study entry and at 3-month intervals, for 1 year.

Results

Of 3,402 women enrolled (mean age 68.2 years [SD] 9.83), 96% were diagnosed with low bone mass; 55% of these using dual energy X-ray absorptiometry. Most women (92%) had comorbidities. Mean minimum T score (hip or spine) at diagnosis was −2.7 (SD 0.89; median −2.7 [interquartile range, −3.2, −2.2]) indicating low bone mineral density. Almost 40% of the women had prior fractures in adulthood, mostly non-vertebral, non-hip in nature, 30% of whom had at least two fractures and more than half experienced moderate/severe pain or fatigue. Bisphosphonates were the most common type of bone loss treatment prescribed in the 12 months preceding the study.

Conclusions

POSSIBLE EU® characterises postmenopausal women with low bone mass, exhibiting a high rate of prevalent fracture, substantial bone fragility and overall comorbidity burden. Clinical strategies for managing osteoporosis in this population varied across the five participating European countries, reflecting their different guidelines, regulations and standards of care.

Summary

Objectives

To assess whether medical students on graduate entry/fast- track programmes perform as well as students on standard courses.

Design

Retrospective cohort study.

Setting

University of Birmingham Medical School.

Participants

Medical students on graduate entry/fast-track course and standard (5-year) course (‘mainstream’).

Main outcome measures

Examination marks from all assessments taken simultaneously by graduate entry course (GEC) and mainstream course students once the cohorts have combined: i.e. for the final three years of the programme. Honours awards for 2007 and 2008 graduates.

Results

In total 19,263 examination results were analysed from 1547 students. Of these 161 were GEC students and 1386 were mainstream medical students. On average mainstream students, male students, overseas students and students of South Asian ethnicity obtained lower examination marks than graduate entry students, female students, home or EU students and students of non-South Asian ethnicity, respectively. Graduate entry students were significantly more likely to achieve honours degrees than mainstream students.

Conclusion

On average the academic performance of Graduate Entry medical students at the University of Birmingham is better than mainstream medical students.

Background

Heart failure is an important cause of cardiovascular morbidity and mortality. Studies to date have not established the prevalence heart failure amongst the minority ethnic community in the UK. T'he aim of the E-ECHOES (Ethnic - Echocardiographic Heart of England Screening Study)is to establish, for the first time, the community prevalence and severity of left ventricular systolic dysfunction (LVSD) and heart failure amongst the South Asian and Black African-Caribbean ethnic groups in the UK.

Methods/Design

This is a community based cross-sectional population survey of a sample of South Asian (i.e. those originating from India, Pakistan, Bangladesh) and Black African-Caribbean male and female subjects aged 45 years and over. Data collection undertaken using a standardised protocol comprising a questionnaire incorporating targeted clinical history taking, physical examination, and investigations with resting electrocardiography and echocardiography; and blood sampling with consent. This is the largest study on heart failure amongst these ethnic groups. Full data collection started in September 2006 and will be completed by August 2009.

Discussion

The E-ECHOES study will enable the planning and delivery of clinically and cost-effective treatment of this common and debilitating condition within these communities. In addition it will increase knowledge of the aetiology and management of heart failure within minority ethnic communities.

Objective To identify predictors of perinatal and infant mortality variations between primary care trusts (PCTs) and identify outlier trusts where outcomes were worse than expected.

Design Prognostic multivariable mixed models attempting to explain observed variability between PCTs in perinatal and infant mortality. We used these predictive models to identify PCTs with higher than expected rates of either outcome.

Setting All primary care trusts in England.

Population For each PCT, data on the number of infant and perinatal deaths, ethnicity, deprivation, maternal age, PCT spending on maternal services, and “Spearhead” status.

Main outcome measures Rates of perinatal and infant mortality across PCTs.

Results The final models for infant mortality and perinatal mortality included measures of deprivation, ethnicity, and maternal age. The final model for infant mortality explained 70% of the observed heterogeneity in outcome between PCTs. The final model for perinatal mortality explained 80.5% of the between-PCT heterogeneity. PCT spending on maternal services did not explain differences in observed events. Two PCTs had higher than expected rates of perinatal mortality.

Conclusions Social deprivation, ethnicity, and maternal age are important predictors of infant and perinatal mortality. Spearhead PCTs are performing in line with expectations given their levels of deprivation, ethnicity, and maternal age. Higher spending on maternity services using the current configuration of services may not reduce rates of infant and perinatal mortality.

Objectives To examine the management of diabetes between 2001 and 2007 in the United Kingdom and to assess whether changes in the quality of care reflect existing temporal trends or are a direct result of the implementation of the quality and outcomes framework.

Design Retrospective cohort study.

Setting 147 general practices (annual list size over 1 million) across the UK.

Patients People with type 1 or type 2 diabetes.

Main outcome measures Annual prevalence of diabetes and attainment of process and clinical outcomes over the three years before and the three years after the introduction of the quality and outcomes framework.

Results Significant improvements in process and intermediate outcome measures were observed during the six year period, with consecutive annual improvements observed before the introduction of incentives. However, the current diagnostic case definition for the quality and outcomes framework does not capture up to two thirds of people with type 1 diabetes and a third of people with type 2 diabetes. After the introduction of the quality and outcomes framework, existing trends of improvement in glycaemic control, cholesterol levels, and blood pressure were attenuated, particularly in people with diabetes who did not meet the case definition of the quality and outcomes framework. The introduction of the quality and outcomes framework did not lead to improvement in the management of patients with type 1 diabetes, nor to a reduction in the number of patients with type 2 diabetes who had HbA1c levels greater than 10%. Introduction of the quality and outcomes framework may have increased the number of patients with type 2 diabetes with HbA1c levels of ≤7.5%; odds ratio 1.05 (95% confidence interval 1.01 to 1.09; P=0.02).

Conclusions The management of people with diabetes has improved since the late 1990s, but the impact of the quality and outcomes framework on care is not straightforward; upper thresholds may need to be removed or targets made more challenging if people are to benefit. Many patients in whom care may be suboptimal may not be captured in the quality and outcomes framework assessment.

Objective To assess the effectiveness of an antenatal service using community based breastfeeding peer support workers on initiation of breast feeding.

Design Cluster randomised controlled trial.

Setting Community antenatal clinics in one primary care trust in a multiethnic, deprived population.

Participants 66 antenatal clinics with 2511 pregnant women: 33 clinics including 1140 women were randomised to receive the peer support worker service and 33 clinics including 1371 women were randomised to receive standard care.

Intervention An antenatal peer support worker service planned to comprise a minimum of two contacts with women to provide advice, information, and support from approximately 24 weeks’ gestation within the antenatal clinic or at home. The trained peer support workers were of similar ethnic and sociodemographic backgrounds to their clinic population.

Main outcome measure Initiation of breast feeding obtained from computerised maternity records of the hospitals where women from the primary care trust delivered.

Results The sample was multiethnic, with only 9.4% of women being white British, and 70% were in the lowest 10th for deprivation. Most of the contacts with peer support workers took place in the antenatal clinics. Data on initiation of breast feeding were obtained for 2398 of 2511 (95.5%) women (1083/1140 intervention and 1315/1371 controls). The groups did not differ for initiation of breast feeding: 69.0% (747/1083) in the intervention group and 68.1% (896/1315) in the control groups; cluster adjusted odds ratio 1.11 (95% confidence interval 0.87 to 1.43). Ethnicity, parity, and mode of delivery independently predicted initiation of breast feeding, but randomisation to the peer support worker service did not.

Conclusion A universal service for initiation of breast feeding using peer support workers provided within antenatal clinics serving a multiethnic, deprived population was ineffective in increasing initiation rates.

Trial registration Current Controlled Trials ISRCTN16126175.

Aims

Cardiac dyssynchrony is common in patients with heart failure, whether or not they have ischaemic heart disease (IHD). The effect of the underlying cause of cardiac dysfunction on the response to cardiac resynchronization therapy (CRT) is unknown. This issue was addressed using data from the CARE-HF trial.

Methods and results

Patients (n = 813) were grouped by heart failure aetiology (IHD n = 339 vs. non-IHD n = 473), and the primary composite (all-cause mortality or unplanned hospitalization for a major cardiovascular event) and principal secondary (all-cause mortality) endpoints analysed. Heart failure severity and the degree of dyssynchrony were compared between the groups by analysing baseline clinical and echocardiographic variables. Patients with IHD were more likely to be in NYHA class IV (7.5 vs. 4.0%; P = 0.03) and to have higher NT-proBNP levels (2182 vs. 1725 pg/L), indicating more advanced heart failure. The degree of dyssynchrony was more pronounced in patients without IHD (assessed using mean QRS duration, interventricular mechanical delay, and aorta-pulmonary pre-ejection time). Left ventricular ejection fraction and left ventricular end-systolic volume improved to a lesser extent in the IHD group (4.53 vs. 8.50% and −35.68 vs. –58.52 cm3). Despite these differences, CRT improved all-cause mortality, NYHA class, and hospitalization rates to a similar extent in patients with or without IHD.

Conclusion

The benefits of CRT in patients with or without IHD were similar in relative terms in the CARE-HF study but as patients with IHD had a worse prognosis, the benefit in absolute terms may be greater.

Objective

The purpose of the trial was to examine the impact of inhaled human insulin (INH) on patient or physician willingness to adopt insulin after oral diabetes agent failure.

Research design and methods

The EXPERIENCE trial was a one-year randomized controlled trial conducted at primary, secondary and tertiary care facilities in Europe and North America. The primary study endpoint was difference in glycated hemoglobin (A1c) between randomized groups at 26 weeks, and results from that phase have been reported previously. The present report concerns results from the second 26-week extension phase. We also consider the applicability of the design. The trial recruited 727 patients with type 2 diabetes mellitus who, prior to randomization, were using two or more oral diabetes agents and whose A1c was ≥ 8.0%. Patients were randomized to two treatment settings: Group 1 (usual care with the option of INH) or Group 2 (usual care only). Usual care included adjusting oral therapy (optimizing current regimen or adding/deleting agents) and/or initiating subcutaneous (SC) insulin.

Results

At baseline, insulin was initiated by more (odds ratio [OR] 6.0;95% confidence interval [CI] 4.2 to 8.8; P < 0.0001) patients in Group 1 (86.2%; 76.7% INH plus 9.5% SC) than in Group 2 (50.7%; SC insulin only). The largest reduction from baseline in A1c was in Group 1 (−2.0 ± 1.2%) at Week 12 and in Group 2 (−1.8 ± 1.3%) at Week 26 (P = 0.003). At 52 weeks, 79.8% were on insulin in Group 1 (67.4% INH; 12.4% SC) vs 58.1% (SC only) in Group 2, and mean (SD) changes in A1c from baseline were −1.9% (1.2%) and −1.8% (1.3%) in Groups 1 and 2, respectively (P = 0.05). Hypoglycemic event rates per patient month were 0.3 and 0.1 in Groups 1 and 2, respectively (P < 0.0001).

Conclusion

The EXPERIENCE trial showed that novel delivery technology can accelerate the adoption of insulin although some attenuation of differences is observed over time. And further, that this was achieved in a population of patients who appeared more ready to move to insulin therapy than observed in standard clinical practice, and a group of physicians who appeared more ready to adopt INH than the majority of physicians.