Feasibility and acceptability of regular weighing, setting weight gain limits and providing feedback by community midwives to prevent excess weight gain during pregnancy: randomised controlled trial and qualitative study.

BACKGROUND: Regular weighing in pregnant women is not currently recommended in many countries but has been suggested to prevent excessive gestational weight gain. This study aimed to establish the feasibility and acceptability of incorporating regular weighing, setting maximum weight gain targets and feedback by community midwives. METHODS: Low risk pregnant women cared for by eight community midwives were randomised to usual care or usual care plus the intervention at 10-14 weeks of pregnancy. The intervention involved community midwives weighing and plotting weight on a weight gain chart, setting weight gain limit targets, giving brief feedback at each antenatal appointment and encouraging women to weigh themselves weekly between antenatal appointments. Women and midwives were interviewed about their views of the intervention. The focus of the study was on process evaluation. RESULTS: Community midwives referred 123 women and 115 were scheduled for their dating scan within the study period. Of these, 84/115 were approached at their dating scan and 76/84 (90.5 %) randomised. Data showed a modest difference favouring the intervention group in the percentage of women gaining excessive gestational weight (23.5 % versus 29.4 %). The intervention group consistently reported smaller increases in depression and anxiety scores throughout pregnancy compared with usual care. Most women commented the intervention was useful in encouraging them to think about their weight and believed it should be part of routine antenatal care. Community midwives felt the intervention could be implemented within routine care without adding substantially to consultation length, thus not perceived as adding substantially to their workload. CONCLUSIONS: The intervention was feasible and acceptable to pregnant women and community midwives and was readily implemented in routine care. TRIAL REGISTRATION: ISRCTN81605162.

A pragmatic randomized controlled trial to evaluate the effectiveness of a facilitated exercise intervention as a treatment for postnatal depression: the PAM-PeRS trial.

BACKGROUND: Postnatal depression affects about 10-15% of women in the year after giving birth. Many women and healthcare professionals would like an effective and accessible non-pharmacological treatment for postnatal depression. METHOD: Women who fulfilled the International Classification of Diseases (ICD)-10 criteria for major depression in the first 6 months postnatally were randomized to receive usual care plus a facilitated exercise intervention or usual care only. The intervention involved two face-to-face consultations and two telephone support calls with a physical activity facilitator over 6 months to support participants to engage in regular exercise. The primary outcome was symptoms of depression using the Edinburgh Postnatal Depression Scale (EPDS) at 6 months post-randomization. Secondary outcomes included EPDS score as a binary variable (recovered and improved) at 6 and 12 months post-randomization. RESULTS: A total of 146 women were potentially eligible and 94 were randomized. Of these, 34% reported thoughts of self-harming at baseline. After adjusting for baseline EPDS, analyses revealed a -2.04 mean difference in EPDS score, favouring the exercise group [95% confidence interval (CI) -4.11 to 0.03, p = 0.05]. When also adjusting for pre-specified demographic variables the effect was larger and statistically significant (mean difference = -2.26, 95% CI -4.36 to -0.16, p = 0.03). Based on EPDS score a larger proportion of the intervention group was recovered (46.5% v. 23.8%, p = 0.03) compared with usual care at 6 months follow-up. CONCLUSIONS: This trial shows that an exercise intervention that involved encouragement to exercise and to seek out social support to exercise may be an effective treatment for women with postnatal depression, including those with thoughts of self-harming.

The effectiveness of exercise as treatment for vasomotor menopausal symptoms: randomised controlled trial.

OBJECTIVE: To investigate the effectiveness of exercise as treatment for vasomotor menopausal symptoms. DESIGN: Three-group randomised controlled trial, two exercise interventions and a control group. SETTING: Primary Care, West Midlands UK. POPULATION: Perimenopausal and postmenopausal women experiencing at least five hot flushes/night sweats per day and not taken MHT in previous 3 months were recruited from 23 general practices. METHODS: Participants in both exercise interventions groups were offered two face-to-face consultations with a physical activity facilitator to support engagement in regular exercise. In addition, one exercise group received a menopause-specific information DVD and written materials to encourage regular exercise and the other exercise group was offered the opportunity to attend exercise social support groups in their communities. Interventions lasted 6 months. MAIN OUTCOME MEASURE: The primary outcome was frequency of hot flushes/night sweats at 6-month up. RESULTS: Two hundred and sixty-one women were randomised (n = 87 per group). Neither of the exercise intervention groups reported significantly less frequent hot flushes/night sweats per week than controls (exercise-DVD versus control: -8.9, 95% CI -20.0 to 2.2; exercise-social support versus control: -5.2, 95% CI -16.7 to 6.3). CONCLUSIONS: This trial indicates that exercise is not an effective treatment for hot flushes/night sweats. Contrary to current clinical guidance, women should not be advised that exercise will relieve their vasomotor menopausal symptoms.

Effectiveness of regular weighing, weight target setting and feedback by community midwives within routine antenatal care in preventing excessive gestational weight gain: randomised controlled trial.

BACKGROUND: Many pregnant women gain excess weight during pregnancy which increases the health risks to the mother and her baby. Interventions to prevent excess weight gain need to be given to the whole population to prevent excess weight gain. The aim of this study was to assess the effectiveness of a simple and brief intervention embedded withinroutine antenatal care to prevent excessive gestation weight gain. METHODS: Six hundred and ten pregnant women (between 10-14 weeks gestation), aged ≥18 years with a body mass index (BMI) ≥18.5 kg/m2, planned to receive community midwife led care or shared care at the time of recruitment are eligible to take part in the study. Women will be recruited from four maternity centres in England. Community midwives complete a short training module before delivering the intervention. In the intervention, midwives weigh women, set maximum weight limits for weight gain at each antenatal appointment and ask women to monitor their weight at home. Themaximum weight limit is adjusted by the midwife at each antenatal appointment if women have exceeded their maximum weight gain limit set at their previous appointment. The intervention will be compared with usual antenatal care. The primary outcome is the proportion of women per group who exceed the Institute of Medicine guidelines for gestational weight gain at 38 weeks of pregnancy according to their early pregnancy BMI category. DISCUSSION: The proposed trial will test a brief intervention comprising regular weighing, target setting and monitoring ofweight during pregnancy that can be delivered at scale as part of routine antenatal care. Using the professional expertise of community midwives, but without specialist training in weight management, the intervention will incur minimal additionalhealthcare costs, and if effective at reducing excess weight gain, is likely to be very cost effective. TRIAL REGISTRATION: Current controlled trials ISRCTN67427351. Date assigned 29/10/2014.

The potential role of NT-proBNP in screening for and predicting prognosis in heart failure: a survival analysis.

OBJECTIVE: To determine the potential role of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in screening for and predicting prognosis in heart failure by examining diagnosis and survival of patients with a raised NT-proBNP at screening. DESIGN: Survival analysis. SETTING: Prospective substudy of the Echocardiographic Heart of England Screening study (ECHOES) to investigate 10-year survival in participants with an NT-proBNP level at baseline. PARTICIPANTS: 594 participants took part in the substudy. Records of all participants in the ECHOES cohort were flagged during the screening phase which ended on 25 February 1999. All deaths until 25 February 2009 were coded. OUTCOME MEASURES: Logistic regression was used to examine whether NT-proBNP is useful in predicting heart failure at screening after adjustment for age, sex and cohort. Kaplan-Meier curves and log rank tests were used to compare survival times of participants according to NT-proBNP level. Cox regression was carried out to assess the prognostic effect of NT-proBNP after allowing for significant covariates and receiver operator curves were used to determine test reliability. RESULTS: The risk of heart failure increased almost 18-fold when NT-proBNP was 150 pg/mL or above (adjusted OR=17.7, 95% CI 4.9 to 63.5). 10-year survival in the general population cohort was 61% (95% CI 48% to 71%) for those with NT-proBNP ≥150 pg/mL and 89% (95% CI 84% to 92%) for those below the cut-off at the time of the initial study. After adjustment for age, sex and risk factors for heart failure, NT-proBNP level ≥150 pg/mL was associated with a 58% increase in the risk of death within 10 years (adjusted HR=1.58, 95% CI 1.09 to 2.30). CONCLUSIONS: Raised NT-proBNP levels, when screening the general population, are predictive of a diagnosis of heart failure (at a lower threshold than guidelines for diagnosing symptomatic patients) and also predicted reduced survival at 10 years.

The feasibility and acceptability of regular weighing of pregnant women by community midwives to prevent excessive weight gain: RCT.

Pregnancy is a critical period for the development of later obesity. Regular weighing of pregnant women is not currently recommended in the UK. This study aimed to demonstrate the feasibility of regular weighing by community midwives (CMWs) as a potential intervention to prevent excessive gestational weight gain. Low risk healthy/overweight pregnant women cared for by eight CMWs were randomised to usual care or usual care plus the intervention at 10-14 weeks of pregnancy. The intervention involved CMWs weighing and charting weight gain on an IOM weight gain chart, setting a weight target and giving brief feedback at antenatal appointments. The focus of the study was on process evaluation outcomes. Data on other outcomes were also collected including gestational weight gain. We interviewed women and CMWs about their views of the intervention. CMWs referred 123 women, 95 agreed to participate and 76 were randomised. Over 90% of women were weighed at 38 weeks of pregnancy demonstrating high follow up. There was no evidence the intervention caused anxiety. Most women commented they had found the intervention useful in encouraging them to think about their weight and believed it should be part of routine antenatal care. CMW's felt the intervention could be implemented within antenatal care without adding substantially to consultation length. To conclude, pregnant women were keen to participate in the study and the intervention was acceptable to pregnant women and CMWs. An effectiveness trial is now planned.

Performance of stroke risk scores in older people with atrial fibrillation not taking warfarin: comparative cohort study from BAFTA trial.

OBJECTIVE: To compare the predictive power of the main existing and recently proposed schemes for stratification of risk of stroke in older patients with atrial fibrillation. DESIGN: Comparative cohort study of eight risk stratification scores. SETTING: Trial of thromboprophylaxis in stroke, the Birmingham Atrial Fibrillation in the Aged (BAFTA) trial. PARTICIPANTS: 665 patients aged 75 or over with atrial fibrillation based in the community who were randomised to the BAFTA trial and were not taking warfarin throughout or for part of the study period. MAIN OUTCOME MEASURES: Events rates of stroke and thromboembolism. RESULTS: 54 (8%) patients had an ischaemic stroke, four (0.6%) had a systemic embolism, and 13 (2%) had a transient ischaemic attack. The distribution of patients classified into the three risk categories (low, moderate, high) was similar across three of the risk stratification scores (revised CHADS(2), NICE, ACC/AHA/ESC), with most patients categorised as high risk (65-69%, n = 460-457) and the remaining classified as moderate risk. The original CHADS(2) (Congestive heart failure, Hypertension, Age ≥ 75 years, Diabetes, previous Stroke) score identified the lowest number as high risk (27%, n = 180). The incremental risk scores of CHADS(2), Rietbrock modified CHADS(2), and CHA(2)DS(2)-VASc (CHA(2)DS(2)-Vascular disease, Age 65-74 years, Sex) failed to show an increase in risk at the upper range of scores. The predictive accuracy was similar across the tested schemes with C statistic ranging from 0.55 (original CHADS(2)) to 0.62 (Rietbrock modified CHADS(2)), with all except the original CHADS(2) predicting better than chance. Bootstrapped paired comparisons provided no evidence of significant differences between the discriminatory ability of the schemes. CONCLUSIONS: Based on this single trial population, current risk stratification schemes in older people with atrial fibrillation have only limited ability to predict the risk of stroke. Given the systematic undertreatment of older people with anticoagulation, and the relative safety of warfarin versus aspirin in those aged over 70, there could be a pragmatic rationale for classifying all patients over 75 as "high risk" until better tools are available.

Reliability of N-terminal proBNP assay in diagnosis of left ventricular systolic dysfunction within representative and high risk populations.

OBJECTIVE: To determine the performance of a new NT-proBNP assay in comparison with brain natriuretic peptide (BNP) in identifying left ventricular systolic dysfunction (LVSD) in randomly selected community populations. METHODS: Blood samples were taken prospectively in the community from 591 randomly sampled individuals over the age of 45 years, stratified for age and socioeconomic status and divided into four cohorts (general population; clinically diagnosed heart failure; patients on diuretics; and patients deemed at high risk of heart failure). Definite heart failure (left ventricular ejection fraction (LVEF) < 40%) was identified in 33 people. Samples were handled as though in routine clinical practice. The laboratories undertaking the assays were blinded. RESULTS: Using NT-proBNP to diagnose LVEF < 40% in the general population, a level of > 40 pmol/l had 80% sensitivity, 73% specificity, 5% positive predictive value (PPV), 100% negative predictive value (NPV), and an area under the receiver-operator characteristic curve (AUC) of 76% (95% confidence interval (CI) 46% to 100%). For BNP to diagnose LVSD, a cut off level of > 33 pmol/l had 80% sensitivity, 88% specificity, 10% PPV, 100% NPV, and AUC of 88% (95% CI 75% to 100%). Similar NPVs were found for patients randomly screened from the three other populations. CONCLUSIONS: Both NT-proBNP and BNP have value in diagnosing LVSD in a community setting, with similar sensitivities and specificities. Using a high cut off for positivity will confirm the diagnosis of LVSD but will miss cases. At lower cut off values, positive results will require cardiac imaging to confirm LVSD.

Impact of heart failure and left ventricular systolic dysfunction on quality of life: a cross-sectional study comparing common chronic cardiac and medical disorders and a representative adult population.

BACKGROUND: Heart failure and left ventricular systolic dysfunction (LVSD) are increasingly common disorders, with outcomes worse than many cancers. Evidence-based therapies, such as ACE inhibitors and beta-blockers, improve prognosis and symptoms, and reduce healthcare expenditure. However, despite the high prevalence and malignant prognosis, few studies have reported the impact of heart failure and LVSD on overall quality of life and, more crucially, have not researched the elderly or those in the community. METHODS: All patients attending the Echocardiographic Heart of England Screening (ECHOES) study of the prevalence of heart failure and LVSD in the community were assessed by clinical history and examination, electrocardiogram and echocardiography, and also completed the SF36 health status questionnaire. Quality of life in patients found to have heart failure, LVSD, and other cardiac and medical conditions are compared with the randomly selected general population sample. Data are generalisable to the UK. RESULTS: 6162 people in the community were screened in the ECHOES study, of whom 5961 (97%) completed the SF36. The health perceptions of 3850 people aged 45 years or older selected randomly from the population were compared with those of 426 patients diagnosed as having definite heart failure. Those with heart failure had significant impairment of all the measured aspects of physical and mental health, in addition to declines in physical functioning. Significantly worse impairment was found in those with more severe heart failure by NYHA class: indeed, NYHA functional class was closely correlated to SF36 score. Patients with asymptomatic left ventricular dysfunction and patients rendered asymptomatic by treatment had similar scores to the random population sample. Those with heart failure reported more severe physical impairment of quality of life than people giving a history of chronic lung disease or arthritis, with less impact on mental health than patients reporting depression. CONCLUSIONS: Patients with heart failure have statistically significant impairment of all aspects of quality of life, not simply physical functioning. The physical (role and functioning) health burden was significantly greater than that suffered in other serious common chronic disorders, whether cardiac or other systems. Optimising treatment to improve NYHA class appears to improve perceptions of quality of life for patients with heart failure. Given the dramatic decline in quality of life with heart failure, this end-point should be a much more important target for healthcare interventions, especially treatments such as ACE inhibitors and beta-blockers that are shown to improve quality of life.

Prevalence of left ventricular systolic dysfunction and heart failure in high risk patients: community based epidemiological study.

OBJECTIVES: To determine the prevalence of left ventricular systolic dysfunction, and of heart failure due to different causes, in patients with risk factors for these conditions. DESIGN: Epidemiological study, including detailed clinical assessment, electrocardiography, and echocardiography. SETTING: 16 English general practices, representative for socioeconomic status and practice type. PARTICIPANTS: 1062 patients (66% response rate) with previous myocardial infarction, angina, hypertension, or diabetes. MAIN OUTCOME MEASURES: Prevalence of systolic dysfunction, both with and without symptoms, and of heart failure, in groups of patients with each of the risk factors. RESULTS: Definite systolic dysfunction (ejection fraction <40%) was found in 54/244 (22.1%, 95% confidence interval 17.1% to 27.9%) patients with previous myocardial infarction, 26/321 (8.1%, 5.4% to 11.6%) with angina, 7/388 (1.8%, 0.7% to 3.7%) with hypertension, and 12/208 (5.8%, 3.0% to 9.9%) with diabetes. In each group, approximately half of these patients had symptoms of dyspnoea, and therefore had heart failure. Overall rates of heart failure, defined as symptoms of dyspnoea plus objective evidence of cardiac dysfunction (systolic dysfunction, atrial fibrillation, or clinically significant valve disease) were 16.0% (11.6% to 21.2%) in patients with previous myocardial infarction, 8.4% (5.6% to 12.0%) in those with angina, 2.8% (1.4% to 5.0%) in those with hypertension, and 7.7% (4.5% to 12.2%) in those with diabetes. CONCLUSION: Many people with ischaemic heart disease or diabetes have systolic dysfunction or heart failure. The data support the need for trials of targeted echocardiographic screening, in view of the major benefits of modern treatment. In contrast, patients with uncomplicated hypertension have similar rates to the general population.

Reliability of N-terminal pro-brain natriuretic peptide assay in diagnosis of heart failure: cohort study in representative and high risk community populations.

OBJECTIVE: To investigate the performance of a novel assay for N-terminal pro-brain natriuretic peptide (NT-proBNP) in diagnosing heart failure in various randomly selected general and high risk community populations. DESIGN: Community cohort study (substudy of the echocardiographic heart of England screening study). SETTING: Four randomly selected general practices in the West Midlands of England. PARTICIPANTS: 591 randomly sampled patients over the age of 45, stratified for age and socioeconomic status and falling into four cohorts (general population, patients with an existing clinical label of heart failure, patients prescribed diuretics, and patients deemed at high risk of heart failure). MAIN OUTCOME MEASURE: Sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under receiver operating characteristic curve for NT-proBNP assay in the diagnosis of heart failure. RESULTS: For NT-proBNP in the diagnosis of heart failure in the general population (population screen), a level of >36 pmol/l had a sensitivity of 100%, a specificity of 70%, a positive predictive value of 7%, a negative predictive value of 100%, and an area under the receiver operating characteristic curve of 0.92 (95% confidence interval 0.82 to 1.0). Similar negative predictive values were found for patients from the three other populations screened. CONCLUSIONS: This NT-proBNP assay seems to have value in the diagnosis of heart failure in the community. High negative predictive values indicate that the assay's chief use would be to rule out heart failure in patients with suspected heart failure with normal concentrations of NT-proBNP. Positive results may identify patients who need cardiac imaging.

Comparison of estimates and calculations of risk of coronary heart disease by doctors and nurses using different calculation tools in general practice: cross sectional study.

OBJECTIVE: To assess the effect of using different risk calculation tools on how general practitioners and practice nurses evaluate the risk of coronary heart disease with clinical data routinely available in patients' records. DESIGN: Subjective estimates of the risk of coronary heart disease and results of four different methods of calculation of risk were compared with each other and a reference standard that had been calculated with the Framingham equation; calculations were based on a sample of patients' records, randomly selected from groups at risk of coronary heart disease. SETTING: General practices in central England. PARTICIPANTS: 18 general practitioners and 18 practice nurses. MAIN OUTCOME MEASURES: Agreement of results of risk estimation and risk calculation with reference calculation; agreement of general practitioners with practice nurses; sensitivity and specificity of the different methods of risk calculation to detect patients at high or low risk of coronary heart disease. RESULTS: Only a minority of patients' records contained all of the risk factors required for the formal calculation of the risk of coronary heart disease (concentrations of high density lipoprotein (HDL) cholesterol were present in only 21%). Agreement of risk calculations with the reference standard was moderate (kappa=0.33-0.65 for practice nurses and 0.33 to 0.65 for general practitioners, depending on calculation tool), showing a trend for underestimation of risk. Moderate agreement was seen between the risks calculated by general practitioners and practice nurses for the same patients (kappa=0.47 to 0.58). The British charts gave the most sensitive results for risk of coronary heart disease (practice nurses 79%, general practitioners 80%), and it also gave the most specific results for practice nurses (100%), whereas the Sheffield table was the most specific method for general practitioners (89%). CONCLUSIONS: Routine calculation of the risk of coronary heart disease in primary care is hampered by poor availability of data on risk factors. General practitioners and practice nurses are able to evaluate the risk of coronary heart disease with only moderate accuracy. Data about risk factors need to be collected systematically, to allow the use of the most appropriate calculation tools.

Prevalence of left-ventricular systolic dysfunction and heart failure in the Echocardiographic Heart of England Screening study: a population based study.

BACKGROUND: Accurate data for prevalence rates for heart failure due to various causes, and for left-ventricular systolic dysfunction in all adults are unavailable. Our aim was to assess prevalence of left-ventricular systolic dysfunction and heart failure in a large representative adult population in England. METHODS: Of 6286 randomly selected patients aged 45 years and older, 3960 (63%) participated in the study. They came from 16 randomly selected general practices. We assessed patients by history and examination, electrocardiography, and echocardiography. Prevalence of left-ventricular systolic dysfunction (defined as ejection fraction <40%) and heart failure was calculated for the overall population on the basis of strict criteria and, when necessary, adjudication by a panel. FINDINGS: Left-ventricular systolic dysfunction was diagnosed in 72 (1.8% [95% CI 1.4-2.3]) participants, half of whom had no symptoms. Borderline left-ventricular function (ejection fraction 40-50%) was seen in 139 patients (3.5% [3.0-4.1]). Definite heart failure was seen in 92 (2.3%, [1.9-2.8]) and was associated with an ejection fraction of less than 40% in 38 (41%) patients, atrial fibrillation in 30 (33%), and valve disease in 24 (26%). Probable heart failure was seen in a further 32 (0.8% [0.6-1.1]) patients. In total, 124 (3.1% [2.6-3.7]) patients aged 45 years or older had definite or probable heart failure. INTERPRETATION: Heart failure is often misdiagnosed or underdiagnosed in primary care. Our results suggest that assessment of left-ventricular function in patients with suspected heart failure could lead to more effective diagnosis and treatment of this disorder.

An audit of prostate-specific antigen and clinical symptoms in general practice.

The objective was to devise local guidelines for the referral of patients with suspected prostatic carcinoma following evaluation by a retrospective audit of the value of the prostate-specific antigen concentration, together with age, urological symptoms, and digital rectal examination in the diagnosis of carcinoma of the prostate. Relevant details were collected from the notes of 582 patients from general practice and hospital. The significant diagnostic factors were ascertained by stepwise logistic regression. Prostate-specific antigen concentration, digital rectal examination and significant terminal dribbling were the most powerful factors in the diagnosis of carcinoma of the prostate. When prostate-specific antigen concentration was considered in isolation, a value of 6.5 ng/ml appeared appropriate for referral. Age was not significant, perhaps due to the narrow patient age range. The significant diagnostic factors were built into an algorithm calculating the probability of carcinoma of the prostate. This algorithm, together with prostate-specific antigen concentration results and digital rectal examination findings, forms the basis of the referral guidelines and a subsequent prospective study.