Background Little is known about how breastfeeding rates are affected by drugs routinely administered in labour.Objective To examine a large obstetric data set to investigate potentially modifiable associations between drugs routinely administered in labour and breastfeeding in healthy women and infants.Design Retrospective cohort.Setting The Cardiff (Wales UK) Births Survey.Population A total of 48 366 healthy women delivering healthy singleton babies at term.Methods Analysis of the Cardiff Births Survey.Main outcome measure Association between intrapartum medications and breastfeeding at 48 hours postpartum.Results At 48 hours, 43.3% (20 933/48 366) women were not breastfeeding. Regression analysis confirmed previously reported associations of lower breastfeeding rates with certain demographic indicators, epidural analgesia, intramuscular opioid analgesia and ergometrine. Novel associations were detected with oxytocin alone or in combination with ergometrine administered for prevention of postpartum haemorrhage (PPH), which were associated with reductions of 6-8%, (intramuscular oxytocin OR 0.75, 95% CI 0.61-0.91, intravenous oxytocin OR 0.68, 95% CI 0.57-0.82, oxytocin/ergometrine OR 0.77, 95% CI 0.65-0.91), and prostaglandins administered for induction of labour. The associations were maintained when subgroups, such as primiparous women, women whose labours were neither induced nor augmented, and women not receiving epidural analgesia were considered.Conclusion Prospective studies on drugs in labour are needed to investigate potential causative associations between intrapartum medications and breastfeeding. Such studies will delineate the optimum balance between breastfeeding and maternal health, most importantly the risk of PPH.

BackgroundThe 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 ResultsThis 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.ConclusionsPotential 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 RegistrationThis 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.

BackgroundQualitative 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.MethodsHealth 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).ResultsThe 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.ConclusionsWe 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.

IntroductionPreventable adverse effects of medicines often pass unnoticed, but lead to real harm.InterventionNurse-led monitoring using the structured Adverse Drug Reaction (ADRe) Profile identifies and addresses adverse effects of mental health medicines.ObjectivesThis study investigated the implementation and clinical impact of ADRe, and barriers to and facilitators of sustained utilisation in routine practice.MethodsAdministration 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.ResultsResidents 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.ImplicationsTo 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.

IntroductionImproved 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 analysisThis 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 disseminationEthical 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 numberNCT03110471.

BackgroundHealth 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/DesignEHL 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.DiscussionThe 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.

Aims Atopic disorders are common in young children. The development of atopy may be influenced by exposure to microbes in early life. We tested the hypothesis that administration of a multi-strain probiotic during pregnancy and to young infants would prevent atopy in childhood. Methods Pregnant women from 36 weeks gestation and their infants to age 6 months took daily either a probiotic consisting of two strains of lactobacilli and two strains of bifidobacteria or a matching placebo. Most infants had a first degree relative with atopy. The primary outcome was diagnosed eczema at age 2 years. Secondary outcomes were skin prick responses (SPRs) to common allergens and immune responses measured at birth and age 6 months. Results 220 infants were randomised to the probiotic and 234 to the placebo group. A similar proportion of infants in the probiotic and placebo group developed eczema (34.1% and 32.4% respectively; p=0.71). A SPR to one or more common allergens occurred in 18/171 (10.5%) infants in the probiotic and 32/173 (18.5%) in the placebo group (OR 0.52, 95% CI 0.28-0.98). The main difference between the groups was in early sensitisation to cow's milk and hen's egg proteins. Atopic eczema (eczema and a positive SPR) occurred in 9/171 (5.3%) children in the probiotic and 21/173 (12.1%) in the placebo group (OR 0.40, 95% CI 0.18-0.91). Cord blood eosinophil count was reduced (p=0.024) and stimulated IL-12p70 concentrations in venous blood at age 6 months elevated (p = 0.022) in the probiotic compared with the control group. Conclusions The probiotic reduced the frequency of atopic eczema and atopic sensitisation and promoted a Th1 orientation of the immune system. Probiotics administered during pregnancy and early infancy may be effective in the prevention of atopy.

Abstract: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.