Promoting children's health when a parent has a mental health problem: a mixed methods study of the experiences and views of health visitors and their co-workers.

BACKGROUND: Unrecognised and untreated parental mental illness is a major adverse childhood experience with potentially life-long consequences for health and wellbeing. In the United Kingdom (UK) health visitors provide a universal health promotion service to children aged 0-5 years, which includes safeguarding. This preventive work is highly relevant to policy aims of improving outcomes for children living with adverse childhood experiences, but is currently under researched. The aim of this study was to explore how health visitors promote young children's wellbeing when a parent has a mental health problem, and to co-produce strategies to improve child health outcomes. METHODS: A mixed methods study was conducted, consisting of a cross-sectional survey and consensus workshops in Wales, UK. In phase 1 health visitors (n = 174) responded to an online questionnaire designed to explore the nature and scope of their preventive work with families experiencing mental ill health. For phase 2 providers of health and other support services (n = 38) took part in Nominal Group Technique workshops to co-produce strategies for better joint working to protect the wellbeing of children living with parental ill health. RESULTS: We identified that health visitors routinely provide support to families where parents have a range of mental health problems, including severe mental illness. Most practice is focused on mothers with depression, and fewer respondents were confident about working with fathers. Unmet training needs were identified in relation to adult mental illness, particularly the impact upon children. Solutions to working more effectively with professional and voluntary agencies included raising awareness of professional roles and responsibilities, timely two-way communication, taking a strengths-based approach and maintaining a focus on the child. CONCLUSIONS: This study provided evidence on the range of parental mental ill health encountered by health visitors and the strategies they use to protect children's wellbeing. Increasing the effectiveness of joint working is key to improving outcomes for babies and young children, including greater use of voluntary sector services. This study has implications for those who commission and provide health and welfare services for children, and adult mental health services.

Nurse-led medicines' monitoring in care homes, implementing the Adverse Drug Reaction (ADRe) Profile improvement initiative for mental health medicines: An observational and interview study.

INTRODUCTION: Preventable adverse effects of medicines often pass unnoticed, but lead to real harm. INTERVENTION: Nurse-led monitoring using the structured Adverse Drug Reaction (ADRe) Profile identifies and addresses adverse effects of mental health medicines. OBJECTIVES: This study investigated the implementation and clinical impact of ADRe, and barriers to and facilitators of sustained utilisation in routine practice. METHODS: Administration of ADRe was observed for 30 residents prescribed mental health medicines in ten care homes. The study pharmacist reviewed completed ADRes against medication records. Policy context was explored in 30 interviews with service users, nurse managers and strategic leads in Wales. RESULTS: Residents were aged 60-95, and prescribed 1-17 (median 9 [interquartile range (IQR) 7-13]) medicines. ADRe identified a median of 18 [IQR 11.5-23] problems per resident and nurses made 2 [1-2] changes to care per resident. For example: falls were reported for 9 residents, and care was modified for 5; pain was identified in 8 residents, and alleviated for 7; all 6 residents recognised as dyspnoeic were referred to prescribers. Nurses referred 17 of 30 residents to prescribers. Pharmacists recommended review for all 30. Doubts about administering ADRe, sometimes expressed by people who had not yet used it, diminished as it became familiar. ADRe was needed to bridge communication between resident, nurses and prescribers. When barriers of time, complacency, and doctors' non-availability were overcome, reporting with ADRe made prescribers more likely to heed nurses' concerns regarding residents' welfare. Clinical gains were facilitated by one-to-one time, staff-resident relationships, and unification of documentation. IMPLICATIONS: To our knowledge, ADRe is the only instrument that brings a full account of patients' problems to medication reviews. This juxtaposition of signs and symptoms against prescriptions facilitates dose adjustments and de-prescribing and leads to: reduced pain and sedation; early identification of problems linked to ADRs, such as falls; and timely medication reviews e.g. for dyspnoea.

Nurse-led medicines' monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines.

INTRODUCTION: Improved medicines' management could lead to real and sustainable improvements to the care of older adults. The overuse of mental health medicines has featured in many reports, and insufficient patient monitoring has been identified as an important cause of medicine-related harms. Nurse-led monitoring using the structured adverse drug reaction (ADRe) profile identifies and addresses the adverse effects of mental health medicines. Our study investigates clinical impact and what is needed to sustain utilisation in routine practice in care homes. METHODS AND ANALYSIS: This process evaluation will use interviews and observations with the participants of all five homes involved in earlier research, and five newly recruited homes caring for people prescribed mental health medicines. The ADRe profile is implemented by nurses, within existing resources, to check for signs and symptoms of ADRs, initiate amelioration and share findings with pharmacists and prescribers for medication review. Outcome measures are the numbers and nature of problems addressed and understanding of changes needed to optimise clinical gain and sustain implementation. Data will be collected by 30 observations and 30 semistructured interviews. Clinical gains will be described and narrated. Interview analysis will be based on the constant comparative method. ETHICS AND DISSEMINATION: Ethical approval was conferred by the National Health Service Wales Research Ethics Committee. If the ADRe profile can be sustained in routine practice, it has potential to (1) improve the lives of patients, for example, by reducing pain and sedation, and (2) assist in early identification of problems caused by ADRs. Therefore, in addition to peer-reviewed publications and conferences, we shall communicate our findings to healthcare professionals, policy-makers and sector regulators. TRIAL REGISTRATION NUMBER: NCT03110471.

Volunteer bias in recruitment, retention, and blood sample donation in a randomised controlled trial involving mothers and their children at six months and two years: a longitudinal analysis.

BACKGROUND: The vulnerability of clinical trials to volunteer bias is under-reported. Volunteer bias is systematic error due to differences between those who choose to participate in studies and those who do not. METHODS AND RESULTS: This paper extends the applications of the concept of volunteer bias by using data from a trial of probiotic supplementation for childhood atopy in healthy dyads to explore 1) differences between a) trial participants and aggregated data from publicly available databases b) participants and non-participants as the trial progressed 2) impact on trial findings of weighting data according to deprivation (Townsend) fifths in the sample and target populations. 1) a) Recruits (n = 454) were less deprived than the target population, matched for area of residence and delivery dates (n = 6,893) (mean [SD] deprivation scores 0.09[4.21] and 0.79[4.08], t = 3.44, df = 511, p<0.001). b) i) As the trial progressed, representation of the most deprived decreased. These participants and smokers were less likely to be retained at 6 months (n = 430[95%]) (OR 0.29,0.13-0.67 and 0.20,0.09-0.46), and 2 years (n = 380[84%]) (aOR 0.68,0.50-0.93 and 0.55,0.28-1.09), and consent to infant blood sample donation (n = 220[48%]) (aOR 0.72,0.57-0.92 and 0.43,0.22-0.83). ii) Mothers interested in probiotics or research or reporting infants' adverse events or rashes were more likely to attend research clinics and consent to skin-prick testing. Mothers participating to help children were more likely to consent to infant blood sample donation. 2) In one trial outcome, atopic eczema, the intervention had a positive effect only in the over-represented, least deprived group. Here, data weighting attenuated risk reduction from 6.9%(0.9-13.1%) to 4.6%(-1.4-+10.5%), and OR from 0.40(0.18-0.91) to 0.56(0.26-1.21). Other findings were unchanged. CONCLUSIONS: Potential for volunteer bias intensified during the trial, due to non-participation of the most deprived and smokers. However, these were not the only predictors of non-participation. Data weighting quantified volunteer bias and modified one important trial outcome. TRIAL REGISTRATION: This randomised, double blind, parallel group, placebo controlled trial is registered with the International Standard Randomised Controlled Trials Register, Number (ISRCTN) 26287422. Registered title: Probiotics in the prevention of atopy in infants and children.

Qualitative research within trials: developing a standard operating procedure for a clinical trials unit.

BACKGROUND: Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. METHODS: Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). RESULTS: The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. CONCLUSIONS: We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.

Protocol of the baseline assessment for the Environments for Healthy Living (EHL) Wales cohort study.

BACKGROUND: Health is a result of influences operating at multiple levels. For example, inadequate housing, poor educational attainment, and reduced access to health care are clustered together, and are all associated with reduced health. Policies which try to change individual people's behaviour have limited effect when people have little control over their environment. However, structural environmental change and an understanding of the way that influences interact with each other, has the potential to facilitate healthy choices irrespective of personal resources. The aim of Environments for Healthy Living (EHL) is to investigate the impact of gestational and postnatal environments on health, and to examine where structural change can be brought about to optimise health outcomes. The baseline assessment will focus on birth outcomes and maternal and infant health. METHODS/DESIGN: EHL is a longitudinal birth cohort study. We aim to recruit 1000 pregnant women in the period April 2010 to March 2013. We will examine the impact of the gestational environment (maternal health) and the postnatal environment (housing and neighbourhood conditions) on subsequent health outcomes for the infants born to these women. Data collection will commence during the participants' pregnancy, from approximately 20 weeks gestation. Participants will complete a questionnaire, undergo anthropometric measurements, wear an accelerometer, compile a food diary, and have environmental measures taken within their home. They will also be asked to consent to having a sample of umbilical cord blood taken following delivery of their baby. These data will be complemented by routinely collected electronic data such as health records from GP surgeries, hospital admissions, and child health and development records. Thereafter, participants will be visited annually for follow-up of subsequent exposures and child health outcomes. DISCUSSION: The baseline assessment of EHL will provide information concerning the impact of gestational and postnatal environments on birth outcomes and maternal and infant health. The findings can be used to inform the development of complex interventions targeted at structural, environmental factors, intended to reduce ill-health. Long-term follow-up of the cohort will focus on relationships between environmental exposures and the later development of adverse health outcomes, including obesity and diabetes.

Antibiotics and allergic disorders in childhood.

AIM: This paper explores the possible association between antibiotics prescribed in infancy and allergic disorders, mainly eczema and asthma, in childhood. BACKGROUND: No-one fully understands why childhood asthma and eczema have become so common. Some authorities suggest that there may be an association between eczema and asthma and antibiotics prescribed in childhood; however, others disagree. METHOD/EVALUATION: The available literature was reviewed to examine the links between prescribed antibiotics and childhood eczema and asthma. FINDINGS/KEY ISSUE: Some, but not all, research indicates that antibiotic administration in pregnancy, childbirth or infancy may be linked to childhood asthma and eczema, but much uncertainty remains. None of the papers identified stated the doses of antibiotics prescribed. In addition, we were unable to locate studies reporting the interactions between antibiotics and the developing immune system. CONCLUSION: Health care professionals should be selective when prescribing antibiotics. Further prospective work is needed to guide the prescribing of antibiotics in childbirth and infancy.

An overview of the immune system.

The immune system comprises: physical and chemical barriers; the non-specific immune mechanisms, which bring about inflammation; and the specific immune system, which recognises and memorises foreign antigens [see glossary on page 55]. The immune system depends on white blood cells that play a key role in protecting the body from invasion by pathogenic microorganisms, infection and disease, particularly cancers. Disorders or disturbances of the immune system can leave the patient vulnerable to infection.