Can primary care research be conducted more efficiently using routinely reported practice-level data: a cluster randomised controlled trial conducted in England?

OBJECTIVES: Conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients' notes is costly and time-consuming. We investigated barriers and facilitators to running a more efficient design. DESIGN: An RCT aiming to reduce antibiotic prescribing among children presenting with acute cough and a respiratory tract infection (RTI) with a clinician-focused intervention, embedded at the practice level. By using aggregate level, routinely collected data for the coprimary outcomes, we removed the need to recruit individual participants. SETTING: Primary care. PARTICIPANTS: Baseline data from general practitioner practices and interviews with individuals from Clinical Research Networks (CRNs) in England who helped recruit practices and Clinical Commission Groups (CCGs) who collected outcome data. INTERVENTION: The intervention included: (1) explicit elicitation of parental concerns, (2) a prognostic algorithm to identify children at low risk of hospitalisation and (3) provision of a printout for carers including safety-netting advice. COPRIMARY OUTCOMES: For 0-9 years old-(1) Dispensing data for amoxicillin and macrolide antibiotics and (2) hospital admission rate for RTI. RESULTS: We recruited 294 of the intended 310 practices (95%) representing 336 496 registered 0-9 years old (5% of all 0-9 years old children). Included practices were slightly larger, had slightly lower baseline prescribing rates and were located in more deprived areas reflecting the national distribution. Engagement with CCGs and their understanding of their role in this research was variable. Engagement with CRNs and installation of the intervention was straight-forward although the impact of updates to practice IT systems and lack of familiarity required extended support in some practices. Data on the coprimary outcomes were almost 100%. CONCLUSIONS: The infrastructure for trials at the practice level using routinely collected data for primary outcomes is viable in England and should be promoted for primary care research where appropriate. TRIAL REGISTRATION NUMBER: ISRCTN11405239.

Protocol for an 'efficient design' cluster randomised controlled trial to evaluate a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: the CHICO study.

INTRODUCTION: Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded 'TARGET' programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren's COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III 'efficiently designed' trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI. METHODS AND ANALYSIS: The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0-9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost-consequence analysis. ETHICS AND DISSEMINATION: Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN11405239.

Relationships between social spending and childhood obesity in OECD countries: an ecological study.

OBJECTIVES: The burden of childhood obesity is clustered among children in low-socioeconomic groups. Social spending on children-public welfare expenditure on families and education-may curb childhood obesity by reducing socioeconomic disadvantages. The objective of this study was to examine the relationship between social spending on children and childhood obesity across the Organisation for Economic Cooperation and Development (OECD) countries. DESIGN: Ecological study. SETTING: Data on social spending on children were obtained from the OECD Social Expenditure Database and the OECD educational finance indicators dataset during 2000-2015. Data on childhood obesity were obtained from the NCD Risk Factor Collaboration database. PARTICIPANTS: Aggregated statistics on obesity among children aged 5-19 years, estimated for OECD 35 countries based on the measured height and weight on 31.5 million children. OUTCOME MEASURES: Country-level prevalence of obesity among children aged 5-19 years. RESULTS: In cross-sectional analyses in 2015, social spending on children was inversely associated with the prevalence of childhood obesity after adjusting for potential confounders (the gross domestic product per capita, unemployment rate, poverty rate, percentage of children aged <20 years and prevalence of childhood obesity in 2000). In addition, when we focused on changes from 2000 to 2015, an average annual increase of US$100 in social spending per child was associated with a decrease in childhood obesity by 0.6 percentage points for girls (p=0.007) and 0.7 percentage points for boys (p=0.04) between 2000 and 2015, after adjusting for the potential confounders. The dimensions of social spending that contributed to these associations between the changes in social spending on children and childhood obesity were early childhood education and care (ECEC) and school education for girls and ECEC for boys. CONCLUSION: Countries that increase social spending on children tend to experience smaller increases in childhood obesity.

What contributes to inappropriate antibiotic dispensing among qualified and unqualified healthcare providers in Bangladesh? A qualitative study.

BACKGROUND: Over-prescribing and inappropriate use of antibiotics contributes to the emergence of antimicrobial resistance (AMR). Few studies in low and middle-income settings have employed qualitative approaches to examine the drivers of antibiotic sale and dispensing across the full range of healthcare providers (HCPs). We aimed to explore understandings of the use and functions of antibiotics; awareness of AMR and perceived patient or customer demand and adherence among HCPs for human and animal medicine in Bangladesh. METHODS: We used an ethnographic approach to conduct face-to-face, in-depth interviews with 46 community HCPs in one urban and one rural area (Gazipur and Mirzapur districts respectively). We purposefully selected participants from four categories of provider in human and veterinary medicine: qualified; semi-qualified; auxiliary and unqualified. Using a grounded theory approach, thematic analysis was conducted using a framework method. RESULTS: Antibiotics were considered a medicine of power that gives quick results and works against almost all diseases, including viruses. The price of antibiotics was equated with power such that expensive antibiotics were considered the most powerful medicines. Antibiotics were also seen as preventative medicines. While some providers were well informed about antibiotic resistance and its causes, others were completely unaware. Many providers mistook antibiotic resistance as the side effects of antibiotics, both in human and animal medicine. Despite varied knowledge, providers showed concern about antibiotic resistance but responsibility for inappropriate antibiotic use was shifted to the patients and clients including owners of livestock and animals. CONCLUSIONS: Misconceptions and misinformation led to a wide range of inappropriate uses of antibiotics across the different categories of human and animal healthcare providers. Low awareness of antibiotic action and antibiotic resistance were apparent among healthcare providers, particularly those with little or no training and those in rural areas. Specific and targeted interventions to address AMR in Bangladesh should include educational messages on the rational use of antibiotics and how they work, targeting all types of healthcare providers. While tailored training for providers may increase understanding of antibiotic action and improve practices, more far-reaching structural changes are required to influence and increase responsibility for optimising antibiotic dispensing among all HCPs.

Pathways to antibiotics in Bangladesh: A qualitative study investigating how and when households access medicine including antibiotics for humans or animals when they are ill.

BACKGROUND: To understand how to reduce antibiotic use, greater knowledge is needed about the complexities of access in countries with loose regulation or enforcement. This study aimed to explore how households in Bangladesh were accessing antimicrobials for themselves and their domestic animals. METHODS: In-depth interviews were conducted with 48 households in one urban and one rural area. Households were purposively sampled from two lower income strata, prioritising those with under 5-year olds, older adults, household animals and minority groups. Households where someone was currently ill with a suspected infection (13 households) were invited for a follow-up interview. Framework analysis was used to explore access to healthcare and medicines. FINDINGS: People accessed medicines for themselves through five pathways: drugs shops, private clinics, government/charitable hospitals, community/family planning clinics, and specialised/private hospitals. Drug shops provided direct access to medicines for common, less serious and acute illnesses. For persistent or serious illnesses, the healthcare pathway may include contacts with several of these settings, but often relied on medicines provided by drug shops. In the 13 households with an unwell family member, most received at least one course of antibiotics for this illness. Multiple and incomplete dosing were common even when prescribed by a qualified doctor. Antibiotics were identified by their high cost compared to other medicines. Cost was a reported barrier to purchasing full courses of antibiotics. Few households in the urban area kept household animals. In this rural area, government animal health workers provided most care for large household animals (cows), but drug shops were also important. CONCLUSIONS: In Bangladesh, unregulated drug shops provide an essential route to medicines including those prescribed in the formal sector. Wherever licensed suppliers are scarce and expensive, regulations which prohibit this supply risk removing access entirely for many people.

Pathways of antibiotic use in Bangladesh: qualitative protocol for the PAUSE study.

INTRODUCTION: Global actions to reduce antimicrobial resistance (AMR) include optimising the use of antimicrobial medicines in human and animal health. In countries with weak healthcare regulation, this requires a greater understanding of the drivers of antibiotic use from the perspective of providers and consumers. In Bangladesh, there is limited research on household decision-making and healthcare seeking in relation to antibiotic use and consumption for humans and livestock. Knowledge is similarly lacking on factors influencing the supply and demand for antibiotics among qualified and unqualified healthcare providers.The aim of this study is to conduct integrated research on household decision-making for healthcare and antibiotic use, as well as the awareness, behaviours and priorities of healthcare providers and sellers of antibiotics to translate into policy development and implementation. METHODS AND ANALYSIS: In-depth interviews will be conducted with (1) household members responsible for decision-making about illness and antibiotic use for family and livestock; (2) qualified and unqualified private and government healthcare providers in human and animal medicine and (3) stakeholders and policy-makers as key informants on the development and implementation of policy around AMR. Participant observation within retail drug shops will also be carried out. Qualitative methods will include a thematic framework analysis.A holistic approach to understanding who makes decisions on the sale and use of antibiotics, and what drives healthcare seeking in Bangladesh will enable identification of routes to behavioural change and the development of effective interventions to reduce the health risks of AMR. ETHICS AND DISSEMINATION: Approval for the study has been obtained from the Institutional Review Board at the International Centre for Diarrhoeal Disease Research, Bangladesh following review by the Research and Ethics Committees (PR-16100) and from Loughborough University (R17-P081). Information about the study will be provided in a participant information letter in Bangla (to be read verbally and given in writing to participants). A written informed consent form in Bangla will be obtained and participants will be informed of their right to withdraw from the study. Dissemination will take place through a 1 day dissemination workshop with key stakeholders in public health and policy, practitioners and scientists in Bangladesh, and through international conference presentations and peer-review publications. Anonymised transcripts of interviews will be made available through open access via institutional data repositories after an embargo period.

Interventions that enhance health services for parents and infants to improve child development and social and emotional well-being in high-income countries: a systematic review.

BACKGROUND: Experiences in the first 1000 days of life have a critical influence on child development and health. Health services that provide support for families need evidence about how best to improve their provision. METHODS: We systematically reviewed the evidence for interventions in high-income countries to improve child development by enhancing health service contact with parents from the antenatal period to 24 months postpartum. We searched 15 databases and trial registers for studies published in any language between 01 January 1996 and 01 April 2016. We also searched 58 programme or organisation websites and the electronic table of contents of eight journals. RESULTS: Primary outcomes were motor, cognitive and language development, and social-emotional well-being measured to 39 months of age (to allow the interventions time to produce demonstrable effects). Results were reported using narrative synthesis due to the variation in study populations, intervention design and outcome measurement. 22 of the 12 986 studies identified met eligibility criteria. Using Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group criteria, the quality of evidence overall was moderate to low. There was limited evidence for intervention effectiveness: positive effects were seen in 1/6 studies for motor development, 4/11 for language development, 4/8 for cognitive development and 3/19 for social-emotional well-being. However, most studies showing positive effects were at high/unclear risk of bias, within-study effects were inconsistent and negative effects were also seen. Intervention content and intensity varied greatly, but this was not associated with effectiveness. CONCLUSIONS: There is insufficient evidence that interventions currently available to enhance health service contacts up to 24 months postpartum are effective for improving child development. There is an urgent need for robust evaluation of existing interventions and to develop and evaluate novel interventions to enhance the offer to all families. PROSPERO REGISTRATION NUMBER: CRD42015015468.

Preschool and School Meal Policies: An Overview of What We Know about Regulation, Implementation, and Impact on Diet in the UK, Sweden, and Australia.

School meals make significant contributions to healthy dietary behaviour, at a time when eating habits and food preferences are being formed. We provide an overview of the approaches to the provision, regulation, and improvement of preschool and primary school meals in the UK, Sweden, and Australia, three countries which vary in their degree of centralisation and regulation of school meals. Sweden has a centralised approach; all children receive free meals, and a pedagogical approach to meals is encouraged. Legislation demands that meals are nutritious. The UK system is varied and decentralised. Meals in most primary schools are regulated by food-based standards, but preschool-specific meal standards only exist in Scotland. The UK uses food groups (starchy foods, fruit and vegetables, proteins and dairy) in a healthy plate approach. Australian States and Territories all employ guidelines for school canteen food, predominantly using a "traffic light" approach outlining recommended and discouraged foods; however, most children bring food from home and are not covered by this guidance. The preschool standards state that food provided should be nutritious. We find that action is often lacking in the preschool years, and suggest that consistent policies, strong incentives for compliance, systematic monitoring, and an acknowledgement of the broader school eating environment (including home provided food) would be beneficial.

Feasibility cluster randomised controlled trial of a within-consultation intervention to reduce antibiotic prescribing for children presenting to primary care with acute respiratory tract infection and cough.

OBJECTIVE: To investigate recruitment and retention, data collection methods and the acceptability of a 'within-consultation' complex intervention designed to reduce antibiotic prescribing. DESIGN: Primary care feasibility cluster randomised controlled trial. SETTING: 32 general practices in South West England recruiting children from October 2014 to April 2015. PARTICIPANTS: Children (aged 3 months to <12 years) with acute cough and respiratory tract infection (RTI). INTERVENTION: A web-based clinician-focussed clinical rule to predict risk of future hospitalisation and a printed leaflet with individualised child health information for carers, safety-netting advice and a treatment decision record. CONTROLS: Usual practice, with clinicians recording data on symptoms, signs and treatment decisions. RESULTS: Of 542 children invited, 501 (92.4%) consented to participate, a month ahead of schedule. Antibiotic prescribing data were collected for all children, follow-up data for 495 (98.8%) and the National Health Service resource use data for 494 (98.6%). The overall antibiotic prescribing rates for children's RTIs were 25% and 15.8% (p=0.018) in intervention and control groups, respectively. We found evidence of postrandomisation differential recruitment: the number of children recruited to the intervention arm was higher (292 vs 209); over half were recruited by prescribing nurses compared with less than a third in the control arm; children in the intervention arm were younger (median age 2 vs 3 years controls, p=0.03) and appeared to be more unwell than those in the control arm with higher respiratory rates (p<0.0001), wheeze prevalence (p=0.007) and global illness severity scores assessed by carers (p=0.045) and clinicians (p=0.01). Interviews with clinicians confirmed preferential recruitment of less unwell children to the trial, more so in the control arm. CONCLUSION: Differential recruitment may explain the paradoxical antibiotic prescribing rates. Future cluster level studies should consider designs which remove the need for individual consent postrandomisation and embed the intervention within electronic primary care records. TRIAL REGISTRATION NUMBER: ISRCTN 23547970 UKCRN STUDY ID: 16891.