Why do women invest in pre-pregnancy health and care? A qualitative investigation with women attending maternity services.

BACKGROUND: Despite the importance attributed to good pre-pregnancy care and its potential to improve pregnancy and child health outcomes, relatively little is known about why women invest in pre-pregnancy health and care. We sought to gain insight into why women invested in pre-pregnancy health and care. METHODS: We carried out 20 qualitative in-depth interviews with pregnant or recently pregnant women who were drawn from a survey of antenatal clinic attendees in London, UK. Interviewees were purposively sampled to include high and low investors in pre-pregnancy health and care, with variation in age, partnership status, ethnicity and pre-existing medical conditions. Data analysis was conducted using the Framework method. RESULTS: We identified three groups in relation to pre-pregnancy health and care: 1) The "prepared" group, who had high levels of pregnancy planning and mostly positive attitudes to micronutrient supplementation outside of pregnancy, carried out pre-pregnancy activities such as taking folic acid and making changes to diet and lifestyle. 2) The "poor knowledge" group, who also had high levels of pregnancy planning, did not carry out pre-pregnancy activities and described themselves as having poor knowledge. Elsewhere in their interviews they expressed a strong dislike of micronutrient supplementation. 3) The "absent pre-pregnancy period" group, had the lowest levels of pregnancy planning and also expressed anti-supplement views. Even discussing the pre-pregnancy period with this group was difficult as responses to questions quickly shifted to focus on pregnancy itself. Knowledge of folic acid was poor in all groups. CONCLUSION: Different pre-pregnancy care approaches are likely to be needed for each of the groups. Among the "prepared" group, who were proactive and receptive to health messages, greater availability of information and better response from health professionals could improve the range of pre-pregnancy activities carried out. Among the "poor knowledge" group, better response from health professionals might yield greater uptake of pre-pregnancy information. A different, general health strategy might be more appropriate for the "absent pre-pregnancy period" group. The fact that general attitudes to micronutrient supplementation were closely related to whether or not women invested in pre-pregnancy health and care was an unanticipated finding and warrants further investigation.

Safety and efficacy of losartan for the reduction of brain atrophy in clinically diagnosed Alzheimer's disease (the RADAR trial): a double-blind, randomised, placebo-controlled, phase 2 trial.

BACKGROUND: Drugs modifying angiotensin II signalling could reduce Alzheimer's disease pathology, thus decreasing the rate of disease progression. We investigated whether the angiotensin II receptor antagonist losartan, compared with placebo, could reduce brain volume loss, as a measure of disease progression, in clinically diagnosed mild-to-moderate Alzheimer's disease. METHODS: In this double-blind, multicentre, randomised controlled trial, eligible patients aged 55 years or older, previously untreated with angiotensin II drugs and diagnosed (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria) with mild-to-moderate Alzheimer's disease, and who had capacity to consent, were recruited from 23 UK National Health Service hospital trusts. After undergoing a 4-week, open-label phase of active treatment then washout, participants were randomly assigned (1:1) oral over-encapsulated preparations of either 100 mg losartan (after an initial two-dose titration stage) or matched placebo daily for 12 months. Randomisation, minimised by age and baseline medial temporal lobe atrophy score, was undertaken online or via pin-access service by telephone. Participants, their study companions, and study personnel were masked to group assignment. The primary outcome, analysed by the intention-to-treat principle (ie, participants analysed in the group to which they were randomised, without imputation for missing data), was change in whole brain volume between baseline and 12 months, measured using volumetric MRI and determined by boundary shift interval (BSI) analysis. The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN93682878) and the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT 2012-003641-15), and is completed. FINDINGS: Between July 22, 2014, and May 17, 2018, 261 participants entered the open-label phase. 211 were randomly assigned losartan (n=105) or placebo (n=106). Of 197 (93%) participants who completed the study, 171 (81%) had complete primary outcome data. The mean brain volume (BSI) reduction was 19·1 mL (SD 10·3) in the losartan group and 20·0 mL (10·8) in the placebo group. The difference in total volume reduction between groups was -2·29 mL (95% CI -6·46 to 0·89; p=0·14). The number of adverse events was low (22 in the losartan group and 20 in the placebo group) with no differences between treatment groups. There was one treatment-related death per treatment group. INTERPRETATION: 12 months of treatment with losartan was well tolerated but was not effective in reducing the rate of brain atrophy in individuals with clinically diagnosed mild-to-moderate Alzheimer's disease. Further research is needed to assess the potential therapeutic benefit from earlier treatment in patients with milder cognitive impairment or from longer treatment periods. FUNDING: Efficacy and Mechanism Evaluation Programme (UK Medical Research Council and National Institute for Health Research).

Preparation for fatherhood: A survey of men's preconception health knowledge and behaviour in England.

METHODS: A cross-sectional survey of men attending antenatal care with their partners at three London Maternity Units. We assessed level of pregnancy planning using the partner version of the London Measure of Unplanned Pregnancy (LMUP), preconception health behaviours, and whether they had sought information and health professional advice before conception. MAIN RESULTS: We recruited 573 men (91% response rate). Mean age was 34 years, 86% were in employment or full time education and 66% had a degree. Half were overweight or obese, 16% were still smoking and 79% had consumed alcohol in the three months before conception. Of 250 men answering questions about medication, a third were taking medication with potentially adverse effects on male reproductive health, while 23% reported taking pre-pregnancy vitamins. 46.9% had looked at information about pregnancy from a variety of sources, including online, before their partner became pregnant. Assessed by the LMUP, 74% of pregnancies were planned. Male 'planners' were more likely than other men to reduce smoking, reduce alcohol consumption and to eat more healthily in preparation for pregnancy. However, 57% took no action to improve their health. SIGNIFICANCE OF THE FINDINGS: In a sample of relatively educated men accompanying their partners on an antenatal visit, nearly half had made at least one positive health behaviour change before pregnancy, but half were overweight or obese and a third were on medication that could impair male reproductive health. These findings, together with a high prevalence of alcohol consumption and smoking, indicate the need for greater paternal preconception health awareness and care. Innovative ways to promote positive messages about fatherhood, including medication review as part of preconception care, should be evaluated for impact on improving paternal reproductive health and pregnancy and neonatal outcomes.

Challenges to and Facilitators of Recruitment to an Alzheimer's Disease Clinical Trial: A Qualitative Interview Study.

BACKGROUND: Low participation in clinical trials is a major challenge to advancing clinical Alzheimer's disease (AD) research and care. Factors influencing recruitment to AD trials are not fully understood. OBJECTIVE: To identify barriers to, and facilitators of, recruitment in a UK multi-center, secondary care AD trial (Reducing pathology in Alzheimer's Disease through Angiotensin TaRgeting (RADAR) trial) and implications for improving recruitment to AD trials. METHODS: Semi-structured qualitative telephone interviews with a purposive sample of 17 trial site staff explored the RADAR trial recruitment pathway and views and experiences of recruitment. Interviews were analyzed thematically. RESULTS: Diagnostic and care pathways hindered identifying patients with mild-moderate AD, with a lack of up-to-date patient records and data access problems affecting screening. Research is not routinely embedded in AD care but facilitated recruitment when it was. Clinicians' and patients' favorable view of the trial purpose facilitated recruitment, although the complexity of participant information sheets and requirement for study companion created challenges. CONCLUSION: These findings have important implications for the design of future AD trials and for planning how to best interface with clinical commitments to ensure sufficient and timely recruitment. Challenges to AD trial recruitment can occur at care pathway, clinician, and patient and companion levels. Recruitment can be facilitated by: improving diagnostic processes and systems for recording and sharing patient information, embedding research into routine patient care, collaborating with a range of services to identify and approach eligible patients, training and engaging trial staff, and providing patients with clear and concise study information.

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

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

General practitioners' knowledge, attitudes and views of providing preconception care: a qualitative investigation.

BACKGROUND: Preconception health and care aims to reduce parental risk factors before pregnancy through health promotion and intervention. Little is known about the preconception interventions that general practitioners (GPs) provide. The aim of this study was to examine GPs' knowledge, attitudes, and views towards preconception health and care in the general practice setting. METHODS: As part of a large mixed-methods study to explore preconception care in England, we surveyed 1,173 women attending maternity units and GP services in London and interviewed women and health professionals. Seven GPs were interviewed, and the framework analysis method was used to analyse the data. FINDINGS: Seven themes emerged from the data: Knowledge of preconception guidelines; Content of preconception advice; Who should deliver preconception care?; Targeting provision of preconception care; Preconception health for men; Barriers to providing preconception care; and Ways of improving preconception care. A lack of knowledge and demand for preconception care was found, and although reaching women before they are pregnant was seen as important it was not a responsibility that could be adequately met by GPs. Specialist preconception services were not provided within GP surgeries, and care was mainly targeted at women with medical conditions. GPs described diverse patient groups with very different health needs. CONCLUSION: Implementation of preconception policy and guidelines is required to engage women and men and to develop proactive delivery of care with the potential to improve pregnancy and neonatal outcomes. The role of education and of nurses in improving preconception health was acknowledged but remains under-developed.

How do women prepare for pregnancy? Preconception experiences of women attending antenatal services and views of health professionals.

MAIN OBJECTIVE: To determine the extent to which women plan and prepare for pregnancy. METHODS: Cross-sectional questionnaire survey of pregnant women attending three maternity services in London about knowledge and uptake of preconception care; including a robust measure of pregnancy planning, and phone interviews with a range of health care professionals. MAIN RESULTS: We recruited 1173/1288 (90%) women, median age of 32 years. 73% had clearly planned their pregnancy, 24% were ambivalent and only 3% of pregnancies were unplanned. 51% of all women and 63% of those with a planned pregnancy took folic acid before pregnancy. 21% of all women reported smoking and 61% reported drinking alcohol in the 3 months before pregnancy; 48% of smokers and 41% of drinkers reduced or stopped before pregnancy. The 51% of all women who reported advice from a health professional before becoming pregnant were more likely to adopt healthier behaviours before pregnancy [adjusted odds ratios for greatest health professional input compared with none were 2.34 (95% confidence interval 1.54-3.54) for taking folic acid and 2.18 (95% CI 1.42-3.36) for adopting a healthier diet before pregnancy]. Interviews with 20 health professionals indicated low awareness of preconception health issues, missed opportunities and confusion about responsibility for delivery of preconception care. SIGNIFICANCE OF THE FINDINGS: Despite a high level of pregnancy planning, awareness of preconception health among women and health professionals is low, and responsibility for providing preconception care is unclear. However, many women are motivated to adopt healthier behaviours in the preconception period, as indicated by halving of reported smoking rates in this study. The link between health professional input and healthy behaviour change before pregnancy is a new finding that should invigorate strategies to improve awareness and uptake of pre-pregnancy health care, and bring wider benefits for public health.