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.

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. 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. 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.

Advances in medicines have increased the effectiveness of treatments and the social and cultural authority of doctors. However, as prescribing has become the dominant modality of treatment, the “pharmaceuticalization” of medical practice has often resulted in treatment “at a distance”, with doctors having limited contact with patients. Older and poorer people, who are socially distanced from medical prescribers, suffer more adverse drug reactions (ADRs) than the general population. A team approach to checking patients systematically for ADRs, as detailed in manufacturers’ literature, can minimise medication errors, but regular review is rare. This paper explains the benefits of medicines monitoring to protect older patients from iatrogenic harm, such as over-sedation, falls, or drug-induced Parkinsonism. We show how multidisciplinary initiatives to optimise prescribing can be supported by using a recognised resource—the adverse drug reaction profile (ADRe). The profile identifies and documents patients’ signs and symptoms of putative ADRs. Better monitoring allows professionals to adjust prescribing and respond to identified problems with agility. Implementation of systematic monitoring will require changes to the regulatory regime and better inter-professional cooperation. Providing carers, nurses and pharmacists with a structured system to monitor patients would democratise relevant medical knowledge and help address ageism and the socio-economic health divide.

Early-life establishment of the gut microbiota plays a role in lifelong health, with disruptions linked to heightened risks of metabolic and immune disorders. Probiotic supplementation may be used to modulate the infant gut microbiome to promote favourable development. Here, we evaluate how Lab4B probiotic supplementation shapes the development of the infant gut microbiome over the first 6 months. Faecal samples collected from infants enrolled in PROBAT (ISRCTN26287422), a randomised, double-blind, placebo-controlled trial, were analysed using culture-dependent and -independent (16S rDNA and metagenomic shotgun sequencing) techniques to examine the composition, diversity, and metabolic capabilities of the microbiome, as well as the abundance of antimicrobial resistance genes (ARGs). Probiotic supplementation encouraged the development of a microbiome with a distinct composition characterised by elevated abundances of Bifidobacteriaceae in the first 6 weeks (p = 0.006) and Lactobacillaceae throughout the first 6 months (p < 0.05 at every 6-week time point), accelerated microbial diversification, reduced abundance of beta-lactam- and cephalosporin-resistance genes, and differences in predicted metabolic capabilities at the start and end points. Supplementation of this neonatal population, which is at high risk of atopy, with the Lab4B probiotic significantly influenced the development of the infant gut microbiota during the first 6 months.

Early-life gut microbiota establishment plays a role in lifelong health, with disruptions linked to heightened risks of metabolic and immune disorders. Probiotic supplementation may be used to modulate the infant gut microbiome to promote favourable development and here we evaluate how Lab4B probiotic supplementation shapes infant gut microbiota development over the first six months. Faecal samples collected from infants enrolled in the PROBAT (ISRCTN26287422) randomised, double-blind, placebo-controlled trial were analysed using culture-dependent, and independent (16S rDNA and metagenomic shotgun sequencing) techniques to examine the composition, diversity, antimicrobial resistance gene (ARG) abundance, and metabolic capabilities of the microbiotas. Probiotic supplementation encouraged the development of a distinct microbiota composition: characterised by elevated abundances of Bifidobacteriaceae in the first 6 weeks (p = 0.006) and Lactobacillaceae throughout the first 6 months (p < 0.05 at every 6-week time point), accelerated microbial diversification, reduced abundance of beta-lactam and cephalosporin resistance genes and differences in predicted metabolic capabilities at start and end points. Supplementation of this high atopy risk neonatal population with the Lab4B probiotic significantly influenced the development of the infant gut microbiota during the first 6 months.