Implementation of the CHIldren with acute COugh (CHICO) intervention to improve antibiotics management: a qualitative study in primary care.

BACKGROUND: Childhood respiratory tract infections (RTIs) are common and can lead to unnecessary antibiotic use and antimicrobial resistance. The CHIldren with COugh (CHICO) intervention incorporates a clinician-focused algorithm (STARWAVe) to predict future hospitalisation risk, elicitation of carer concerns, and a carer-focused personalised leaflet recording treatment decisions and safety-netting information. AIM: To examine the implementation of the CHICO intervention by primary care clinicians. DESIGN AND SETTING: A qualitative study with primary care clinicians in England taking part in the CHICO randomised controlled trial. METHOD: Interviews explored the CHICO intervention's acceptability and use. Clinicians from a range of practices with high and low antibiotic dispensing rates were recruited. Normalisation process theory underpinned data collection and thematic analysis. RESULTS: Most clinicians liked the intervention because it was quick and easy to use, it helped elicit carer concerns, and reassured clinicians and carers of the appropriateness of treatment decisions. However, clinicians used it as a supportive aid for treatment decisions rather than as a tool for behaviour change. The accompanying advice leaflet helped explain treatment decisions and support self-care. The intervention did not always align with clinicians' usual processes, which could affect use. Increased familiarisation with the algorithm led to reduced intervention use, which was further reduced during the COVID-19 pandemic as a result of changes to practice and remote consultations. CONCLUSION: Clinicians found the CHICO intervention useful to support decision making around antibiotic prescribing and it helped discussions with carers about concerns and treatment decisions. The intervention may need to be adapted to align more with clinicians' consultation flow and remote consultations.

Real-time monitoring and feedback to improve shared decision-making for surgery (the ALPACA Study): protocol for a mixed-methods study to inform co-development of an inclusive intervention.

INTRODUCTION: High-quality shared decision-making (SDM) is a priority of health services, but only achieved in a minority of surgical consultations. Improving SDM for surgical patients may lead to more effective care and moderate the impact of treatment consequences. There is a need to establish effective ways to achieve sustained and large-scale improvements in SDM for all patients whatever their background. The ALPACA Study aims to develop, pilot and evaluate a decision support intervention that uses real-time feedback of patients' experience of SDM to change patients' and healthcare professionals' decision-making processes before adult elective surgery and to improve patient and health service outcomes. METHODS AND ANALYSIS: This protocol outlines a mixed-methods study, involving diverse stakeholders (adult patients, healthcare professionals, members of the community) and three National Health Service (NHS) trusts in England. Detailed methods for the assessment of the feasibility, usability and stakeholder views of implementing a novel system to monitor the SDM process for surgery automatically and in real time are described. The study will measure the SDM process using validated instruments (CollaboRATE, SDM-Q-9, SHARED-Q10) and will conduct semi-structured interviews and focus groups to examine (1) the feasibility of automated data collection, (2) the usability of the novel system and (3) the views of diverse stakeholders to inform the use of the system to improve SDM. Future phases of this work will complete the development and evaluation of the intervention. ETHICS AND DISSEMINATION: Ethical approval was granted by the NHS Health Research Authority North West-Liverpool Central Research Ethics Committee (reference: 21/PR/0345). Approval was also granted by North Bristol NHS Trust to undertake quality improvement work (reference: Q80008) overseen by the Consent and SDM Programme Board and reporting to an Executive Assurance Committee. TRIAL REGISTRATION NUMBER: ISRCTN17951423; Pre-results.

Maternal vaccination provision in NHS maternity trusts across England.

BACKGROUND: Vaccinations for seasonal influenza and pertussis have been recommended for pregnant women in England since 2010 and 2012, respectively. Uptake rates are suboptimal with large regional variations. To improve uptake, from 2016 onwards maternity trusts were commissioned to offer pertussis (and other) vaccinations in addition to these being available in primary care. Since 2021, Covid-19 vaccination has also been recommended for pregnant women. Overall maternal vaccination rates are routinely available, but not the relative provision by maternity trusts. We aimed to describe the national picture of maternity trust provision of maternal vaccinations, including how the maternity trust vaccination programme has progressed. METHODS: Cross-sectional survey plus comparisons with 2017-18 figures for maternity trust provision of pertussis vaccination, and with UKHSA data for total pertussis vaccination. RESULTS: Twelve NHS commissioners participated (from 13/06/22 to 31/03/23) providing data for 120 (of a total 124) maternity trusts across England. All 120 (100%) trusts were commissioned to deliver influenza, and 107 (89%) to deliver pertussis vaccinations, though not all actually administered the vaccines; 29% offered Covid-19 vaccinations. For 2021-22 we found a mean of 25% (range 0-81.3%) women were vaccinated for pertussis (a large increase compared with previous estimates for 2017-18); and 11% (range 0-74.2%) for influenza, via their maternity trust. Commissioners reported a negative impact of the pandemic on routine vaccination provision. There was indication of efficiency by vaccinating women attending for other appointments. There are diverse mechanisms for reporting pertussis and influenza vaccinations administered at maternity trusts back to primary care, which may be inefficient for maternity staff workload and accuracy of data transfer (especially for pertussis). CONCLUSION: A high proportion of maternity trusts provide both pertussis and influenza vaccinations, despite a negative impact of the pandemic. Reasons for large between-trust variation in vaccination rates should be explored to improve uptake and equity.

Views and Perceptions of People Aged 55+ on the Vaccination Programme for Older Adults in the UK: A Qualitative Study.

Vaccination reduces the risks related to infectious disease, especially among more vulnerable groups, such as older adults. The vaccines available to older adults in the UK through the government-funded programme currently include influenza, pneumococcal, shingles and COVID-19 vaccines. The purpose of the programme is disease prevention and improving wellbeing among the ageing population. Yet, the target population's views of the programme remain unknown. This paper aims to increase the understanding of older adults' perceptions of the vaccination programme available in the UK. A total of 13 online focus groups (56 informants) were carried out for this qualitative study. The findings indicate that getting vaccinated involves personal decision-making processes, which are influenced by previous experiences and interpersonal interactions. Factors related to the wider community and culture are less prominent in explaining vaccination decisions. However, opportunistic vaccination offers, a lack of information and a lack of opportunities to discuss vaccines, especially with healthcare professionals, are prominent factors. The study provides in-depth data about the rationale behind older adults' vaccination decisions in the UK. We recommend that the provision of information and opportunities to discuss vaccines and infectious disease be improved to enable older adults' to make better informed decisions regarding the vaccines available to them.

Multi-faceted intervention to improve management of antibiotics for children presenting to primary care with acute cough and respiratory tract infection (CHICO): efficient cluster randomised controlled trial.

OBJECTIVE: To assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections would reduce antibiotic dispensing, without increasing hospital admissions for respiratory tract infection. DESIGN: Two arm randomised controlled trial clustered by general practice, using routine outcome data, with qualitative and economic evaluations. SETTING: English primary care practices using the EMIS electronic medical record system. PARTICIPANTS: Children aged 0-9 years presenting with respiratory tract infection at 294 general practices, before and during the covid-19 pandemic. INTERVENTION: Elicitation of parental concerns during consultation; a clinician focused prognostic algorithm to identify children at very low, normal, or elevated 30 day risk of hospital admission accompanied by antibiotic prescribing guidance; and a leaflet for carers including safety netting advice. MAIN OUTCOME MEASURES: Rate of dispensed amoxicillin and macrolide antibiotics (superiority comparison) and hospital admissions for respiratory tract infection (non-inferiority comparison) for children aged 0-9 years over 12 months (same age practice list size as denominator). RESULTS: Of 310 practices needed, 294 (95%) were randomised (144 intervention and 150 controls) representing 5% of all registered 0-9 year olds in England. Of these, 12 (4%) subsequently withdrew (six owing to the pandemic). Median intervention use per practice was 70 (by a median of 9 clinicians). No evidence was found that antibiotic dispensing differed between intervention practices (155 (95% confidence interval 138 to 174) items/year/1000 children) and control practices (157 (140 to 176) items/year/1000 children) (rate ratio 1.011, 95% confidence interval 0.992 to 1.029; P=0.25). Pre-specified subgroup analyses suggested reduced dispensing in intervention practices with fewer prescribing nurses, in single site (compared with multisite) practices, and in practices located in areas of lower socioeconomic deprivation, which may warrant future investigation. Pre-specified sensitivity analysis suggested reduced dispensing among older children in the intervention arm (P=0.03). A post hoc sensitivity analysis suggested less dispensing in intervention practices before the pandemic (rate ratio 0.967, 0.946 to 0.989; P=0.003). The rate of hospital admission for respiratory tract infections in the intervention practices (13 (95% confidence interval 10 to 18) admissions/1000 children) was non-inferior compared with control practices (15 (12 to 20) admissions/1000 children) (rate ratio 0.952, 0.905 to 1.003). CONCLUSIONS: This multifaceted antibiotic stewardship intervention for children with respiratory tract infections did not reduce overall antibiotic dispensing or increase respiratory tract infection related hospital admissions. Evidence suggested that in some subgroups and situations (for example, under non-pandemic conditions) the intervention slightly reduced prescribing rates but not in a clinically relevant way. TRIAL REGISTRATION: ISRCTN11405239ISRCTN registry ISRCTN11405239.

A multifaceted intervention to reduce antibiotic prescribing among CHIldren with acute COugh and respiratory tract infection: the CHICO cluster RCT.

Background: Clinical uncertainty in primary care regarding the prognosis of children with respiratory tract infections contributes to the unnecessary use of antibiotics. Improved identification of children at low risk of future hospitalisation might reduce clinical uncertainty. A National Institute for Health and Care Research-funded 5-year programme (RP-PG-0608-10018) was used to develop and feasibility test an intervention. Objectives: The aim of the children with acute cough randomised controlled trial was to reduce antibiotic prescribing among children presenting with acute cough and respiratory tract infection without increasing hospital admission. Design: An efficient, pragmatic open-label, two-arm trial (with embedded qualitative and health economic analyses) using practice-level randomisation using routinely collected data as the primary outcome. Setting: General practitioner practices in England. Participants: General practitioner practices using the Egton Medical Information Systems® patient-record system for children aged 0-9 years presenting with a cough or upper respiratory tract infection. Recruited by Clinical Research Networks and Clinical Commissioning Groups. Intervention: Comprised: (1) elicitation of parental concerns during consultation; (2) a clinician-focused prognostic algorithm to identify children with acute cough and respiratory tract infection at low, average or elevated risk of hospitalisation in the next 30 days accompanied by prescribing guidance, (3) provision of a printout for carers including safety-netting advice. Main outcome measures: Co-primaries using the practice list-size for children aged 0-9 years as the denominator: rate of dispensed amoxicillin and macrolide items at each practice (superiority comparison) from NHS Business Services Authority ePACT2 and rate of hospital admission for respiratory tract infection (non-inferiority comparison) from Clinical Commissioning Groups, both routinely collected over 12 months. Results: Of the 310 practices required, 294 (95%) were recruited (144 intervention and 150 controls) with 336,496 registered 0-9-year-olds (5% of all 0-9-year-old children in England) from 47 Clinical Commissioning Groups. Included practices were slightly larger than those not included, had slightly lower baseline dispensing rates and were located in more deprived areas (reflecting the distribution for practice postcodes nationally). Twelve practices (4%) subsequently withdrew (six related to the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices [0.155 (95% confidence interval 0.135 to 0.179)] differed to controls [0.154 (95% confidence interval 0.130 to 0.182), relative risk= 1.011 (95% confidence interval 0.992 to 1.029); p = 0.253]. There was, overall, a reduction in dispensing levels and intervention usage during the pandemic. The rate of hospitalisation for respiratory tract infection in the intervention practices [0.019 (95% confidence interval 0.014 to 0.026)] compared to the controls [0.021 (95% confidence interval 0.014 to 0.029)] was non-inferior [relative risk = 0.952 (95% confidence interval 0.905 to 1.003)]. The qualitative evaluation found the clinicians liked the intervention, used it as a supportive aid, especially with borderline cases but that it, did not always integrate well within the consultation flow and was used less over time. The economic evaluation found no evidence of a difference in mean National Health Service costs between arms; mean difference -£1999 (95% confidence interval -£6627 to 2630). Conclusions: The intervention was feasible and subjectively useful to practitioners, with no evidence of harm in terms of hospitalisations, but did not impact on antibiotic prescribing rates. Future work and limitations: Although the intervention does not appear to change prescribing behaviour, elements of the approach may be used in the design of future interventions. Trial registration: This trial is registered as ISRCTN11405239 (date assigned 20 April 2018) at www.controlled-trials.com (accessed 5 September 2022). Version 4.0 of the protocol is available at: https://www.journalslibrary.nihr.ac.uk/ (accessed 5 September 2022). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (NIHR award ref: 16/31/98) programme and is published in full in Health Technology Assessment; Vol. 27, No. 32. See the NIHR Funding and Awards website for further award information.

Coughs and colds (also known as respiratory tract infections) are the most common reason that children are taken to family doctors and nurses in primary care. These clinicians are not always sure how best to treat them and often use antibiotics 'just in case'. There are now concerns that clinicians are using antibiotics too often, and that this is increasing the number of resistant bugs (bacteria that cannot be killed by antibiotics). We wanted to see if using a scoring system of symptoms and signs of illness to help clinicians identify children very unlikely to need hospital care as well as listening to parents' concerns and giving them a personalised leaflet with care and safety advice, reduced antibiotic use. We recruited practices rather than patients, so did not need individual patient consent. The two main outcomes were the rate of antibiotics dispensed for children and number of children admitted to hospital for respiratory tract infections, using routinely collected data for 0­9-year-olds. We recruited 294 general practitioner practices, which was 95% of the total needed; 144 were asked to use the intervention and 150 to continue providing usual care (controls); only 12 practices subsequently withdrew (6 related to the pandemic). The average number of times the intervention was used was 70 per practice (by an average of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices differed from control practices. Further analyses showed an overall reduction in dispensing levels and intervention usage during the pandemic. The rate of hospitalisation for respiratory tract infection in the intervention practices was similar to the control practices. In the interviews, we found that clinicians liked the intervention and used it as a supportive aid during consultations, especially for borderline cases, rather than a tool to change prescribing behaviour.

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.

Identifying key influences on antibiotic use in China: a systematic scoping review and narrative synthesis.

INTRODUCTION: The inappropriate use of antibiotics is a key driver of antimicrobial resistance. In China, antibiotic prescribing and consumption exceed recommended levels and are relatively high internationally. Understanding the influences on antibiotic use is essential to informing effective evidence-based interventions. We conducted a scoping review to obtain an overview of empirical research about key behavioural, cultural, economic and social influences on antibiotic use in China. METHODS: Searches were conducted in Econlit, Medline, PsycINFO, Social Science citation index and the Cochrane Database of Systematic Reviews for the period 2003 to early 2018. All study types were eligible including observational and intervention, qualitative and quantitative designs based in community and clinical settings. Two authors independently screened studies for inclusion. A data extraction form was developed incorporating details on study design, behaviour related to antibiotic use, influences on behaviour and information on effect (intervention studies only). RESULTS: Intervention studies increased markedly from 2014, and largely focused on the impact of national policy and practice directives on antibiotic use in secondary and tertiary healthcare contexts in China. Most studies used pragmatic designs, such as before and after comparisons. Influences on antibiotic use clustered under four themes: antibiotic prescribing; adherence to antibiotics; self-medicating behaviour and over-the-counter sale of antibiotics. Many studies highlighted the use of antibiotics without a prescription for common infections, which was facilitated by availability of left-over medicines and procurement from local pharmacies. CONCLUSIONS: Interventions aimed at modifying antibiotic prescribing behaviour show evidence of positive impact, but further research using more robust research designs, such as randomised trials, and incorporating process evaluations is required to better assess outcomes. The effect of national policy at the primary healthcare level needs to be evaluated and further exploration of the influences on antibiotic self-medicating is required to develop interventions that tackle this behaviour.

Antibiotic Stewardship in Retail Pharmacies and the Access-Excess Challenge in China: A Policy Review.

In China, efforts to restrict excessive antibiotic consumption may prevent sufficient access to these life-saving drugs among the most deprived in society because of the weak primary health care system. This makes antibiotic stewardship in the retail pharmacy sector a particular challenge. We conducted an analysis to examinate policies on antibiotic sales in retail pharmacies in China and how tensions between 'excess' and 'access' are managed. The analysis was guided by the Walt and Gilson health policy analysis triangle to systematically analyse policies based on the content of policies, contexts, governance processes, and actors. Nine research studies and 25 documents identified from national and international sources were extracted, grouped into categories, and examined within and across records and categories. As of 2020, eight key policies have been introduced in China that focus on two areas: dispending prescribed medicines or antimicrobials with a prescription and having a licensed pharmacist present in the retail pharmacies, with approaches having changed over time. Inappropriate sales of antibiotics are still common in retail pharmacies, which can be linked to the lack of consistency and enforcement of published policies, the profit-driven nature of retail pharmacies, and the displacement of the demand for antibiotics from clinical into less regulated settings.

Links between obesity, weight stigma and learning in adolescence: a qualitative study.

BACKGROUND: Educational attainment is a key social determinant of health. Health and education are linked by multiple pathways, many of which are not well understood. One such pathway is the association between being above a healthy weight and lower academic achievement. While various explanations have been put forward to explain this relationship, evidence for causal pathways is sparse and unclear. This study addresses that evidence gap. METHODS: We interviewed 19 adults (late 20s; 14 female, 5 male) and one young person (14 years, male) from the UK in 2019/2020. Participants were recruited from the ALSPAC 1990s birth cohort, sampled to ensure diversity in socio-economic status and educational attainment, and a community-based weight management group for young people. Interviews focused on experiences of being above a healthy weight during secondary school and how this may have affected their learning and achievement. Interviews were face-to-face, digitally recorded, and transcribed verbatim. We analysed the data thematically. RESULTS: We identified key pathways through which higher body weight may negatively impact educational performance and showed how these are linked within a novel theoretical model. Because larger body size is highly stigmatised, participants engaged in different strategies to minimise their exposure to negative attention. Participants sought to increase their social acceptance or become less socially visible (or a combination of both). A minority navigated this successfully; they often had many friends (or the 'right' friends), experienced little or no bullying at school and weight appeared to have little effect on their achievement at school. For most however, the behaviours resulting from these strategies (e.g. disruptive behaviour, truanting, not working hard) or the physical, social or mental impacts of their school experiences (e.g. hungry, tired, self-conscious, depressed) made it difficult to concentrate and/or participate in class, which in turn affected how teachers viewed them. CONCLUSIONS: Action to combat weight stigma, both within schools and in wider society, is urgently required to help address these educational disparities that in turn can impact health in later life.

Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol.

INTRODUCTION: Up to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities. METHODS AND ANALYSIS: A cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally. TRIAL REGISTRATION NUMBER: ISRCTN30652037.

The impact of the Covid-19 pandemic on the uptake of routine maternal and infant vaccines globally: A systematic review.

Maintaining routine vaccination coverage is essential to avoid outbreaks of vaccine-preventable diseases. We aimed to understand the international impact of the COVID-19 pandemic on routine vaccination in pregnant women and children aged 0-5-years-old. A systematic review of quantitative and mixed methods studies exploring changes in vaccination coverage, vaccination services, and vaccine confidence since the start of the Covid-19 pandemic was conducted. MEDLINE, EMBASE, CINHAL, PsychINFO, Web of Science, Google Scholar, World Health Organisation, UK Government Joint Committee on Vaccination and Immunisation (including EU and US equivalents), and SAGE Journals were searched between 15-17th June 2021. Selected studies included pregnant women, health professionals, and/or infants aged 0-5-years-old including their parents (population); reported on the Covid-19 pandemic (exposure); presented comparisons with pre-COVID-19 pandemic period (comparator) and reported changes in routine maternal and infant vaccination coverage, services, and confidence (outcomes). Sources published only in non-English language were excluded. The Newcastle Ottawa Scale was used to assess study quality and risk of bias (ROB), and a narrative synthesis was undertaken. This review has been registered with PROSPERO (CRD42021262449). 30 studies were included in the review; data from 20 high-income countries (HICs), seven low- and middle-income countries (LMICs), and three regional studies (groups of countries). 18 studies had a low ROB, 12 had a higher risk, however both low and high ROB studies showed similar results. Two studies meeting the inclusion criteria discussed changes in routine vaccinations for pregnant women while 29 studies discussed infants. Both groups experienced declines in vaccination coverage (up to -79%) with larger disruptions in the accessibility and delivery of vaccination services reported within LMICs compared to HICs. Changes in vaccine confidence remained unclear. The COVID-19 pandemic resulted in decreased vaccine coverage and reduced routine vaccination services for pregnant women and infants, impacts on vaccine confidence requires more research.

Immediate oral versus immediate topical versus delayed oral antibiotics for children with acute otitis media with discharge: the REST three-arm non-inferiority electronic platform-supported RCT.

BACKGROUND: Acute otitis media is a painful infection of the middle ear that is commonly seen in children. In some children, the eardrum spontaneously bursts, discharging visible pus (otorrhoea) into the outer ear. OBJECTIVE: To compare the clinical effectiveness of immediate topical antibiotics or delayed oral antibiotics with the clinical effectiveness of immediate oral antibiotics in reducing symptom duration in children presenting to primary care with acute otitis media with discharge and the economic impact of the alternative strategies. DESIGN: This was a pragmatic, three-arm, individually randomised (stratified by age < 2 vs. ≥ 2 years), non-inferiority, open-label trial, with economic and qualitative evaluations, supported by a health-record-integrated electronic trial platform [TRANSFoRm (Translational Research and Patient Safety in Europe)] with an internal pilot. SETTING: A total of 44 English general practices. PARTICIPANTS: Children aged ≥ 12 months and < 16 years whose parents (or carers) were seeking medical care for unilateral otorrhoea (ear discharge) following recent-onset (≤ 7 days) acute otitis media. INTERVENTIONS: (1) Immediate ciprofloxacin (0.3%) solution, four drops given three times daily for 7 days, or (2) delayed 'dose-by-age' amoxicillin suspension given three times daily (clarithromycin twice daily if the child was penicillin allergic) for 7 days, with structured delaying advice. All parents were given standardised information regarding symptom management (paracetamol/ibuprofen/fluids) and advice to complete the course. COMPARATOR: Immediate 'dose-by-age' oral amoxicillin given three times daily (or clarithromycin given twice daily) for 7 days. Parents received standardised symptom management advice along with advice to complete the course. MAIN OUTCOME MEASURE: Time from randomisation to the first day on which all symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea and episodes of distress/crying) were rated 'no' or 'very slight' problem (without need for analgesia). METHODS: Participants were recruited from routine primary care appointments. The planned sample size was 399 children. Follow-up used parent-completed validated symptom diaries. RESULTS: Delays in software deployment and configuration led to small recruitment numbers and trial closure at the end of the internal pilot. Twenty-two children (median age 5 years; 62% boys) were randomised: five, seven and 10 to immediate oral, delayed oral and immediate topical antibiotics, respectively. All children received prescriptions as randomised. Seven (32%) children fully adhered to the treatment as allocated. Symptom duration data were available for 17 (77%) children. The median (interquartile range) number of days until symptom resolution in the immediate oral, delayed oral and immediate topical antibiotic arms was 6 (4-9), 4 (3-7) and 4 (3-6), respectively. Comparative analyses were not conducted because of small numbers. There were no serious adverse events and six reports of new or worsening symptoms. Qualitative clinician interviews showed that the trial question was important. When the platform functioned as intended, it was liked. However, staff reported malfunctioning software for long periods, resulting in missed recruitment opportunities. Troubleshooting the software placed significant burdens on staff. LIMITATIONS: The over-riding weakness was the failure to recruit enough children. CONCLUSIONS: We were unable to answer the main research question because of a failure to reach the required sample size. Our experience of running an electronic platform-supported trial in primary care has highlighted challenges from which we have drawn recommendations for the National Institute for Health Research (NIHR) and the research community. These should be considered before such a platform is used again. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12873692 and EudraCT 2017-003635-10. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 67. See the NIHR Journals Library website for further project information.

Ear infections are common in childhood. Some are complicated by a burst eardrum, followed by discharge from the ear. The usual treatment for this is a short course of antibiotics taken by mouth. However, alternative treatment using antibiotic drops, or a 'wait and see' policy before starting antibiotics, would result in less antibiotic use and reduce the subsequent risk of antibiotic resistance, which is bad for both patients and the environment. This study set out to see if these alternative treatments were as effective as the usual treatment for children with ear discharge. Although ear infections are common, only one in six children develops ear discharge, so only a few children might be available to take part at each general practice. We planned to use an electronic recruitment system to help us to gather enough patients. The system [called the 'TRANSFoRm' (Translational Research and Patient Safety in Europe) platform] was designed to remind busy general practitioners and nurses about the study and take them through the recruitment process step by step, as well as to support trial processes. Although the TRANSFoRm platform had been developed and tested, it had not been used in general practices before. We were surprised to find that there were many technical problems in setting up the TRANSFoRm platform in general practices, and staff were too busy and/or did not have the skills to overcome the technical issues. As a result, recruiting patients was slow and the study was halted before we had enough children to answer the main research question. In total, we managed to get 44 general practices and 22 children, but this was not enough. We still think that this kind of research and electronic trial platforms are important. We have noted many system and technical issues that need to be solved to enable funders and researchers to use this recruitment approach in the future.

The impact of COVID-19 on primary health care and antibiotic prescribing in rural China: qualitative study.

BACKGROUND: In China, the primary health care (PHC) system has been designated responsible for control and prevention of COVID-19, but not treatment. Suspected COVID-19 cases presenting to PHC facilities must be transferred to specialist fever clinics. This study aims to understand the impact of COVID-19 on PHC delivery and on antibiotic prescribing at a community level in rural areas of central China. METHODS: Qualitative semi-structured interviews were conducted with 18 PHC practitioners and seven patients recruited from two township health centres and nine village clinics in two rural residential areas of Anhui province. Interviews were transcribed verbatim and analysed thematically. RESULTS: PHC practitioners reported a major shift in their work away from seeing and treating patients (due to government-mandated referral to specialist Covid clinics) to focus on the key public health roles of tracing, screening and educating in rural areas. The additional work, risk, and financial pressure that PHC practitioners faced, placed considerable strain on them, particularly those working in village clinics. Face to face PHC provision was reduced and there was no substitution with consultations by phone or app, which practitioners attributed to the fact that most of their patients were elderly and not willing or able to switch. Practitioners saw COVID-19 as outside of their area of expertise and very different to the non-COVID-19 respiratory tract infections that they frequently treated pre-pandemic. They reported that antibiotic prescribing was reduced overall because far fewer patients were attending rural PHC facilities, but otherwise their antibiotic prescribing practices remained unchanged. CONCLUSIONS: The COVID-19 pandemic had considerable impact on PHC in rural China. Practitioners took on substantial additional workload as part of epidemic control and fewer patients were seen in PHC. The reduction in patients seen and treated in PHC led to a reduction in antibiotic prescribing, although clinical practice remains unchanged. Since COVID-19 epidemic control work has been designated as a long-term task in China, rural PHC clinics now face the challenge of how to balance their principal clinical and increased public health roles and, in the case of the village clinics, remain financially viable.

Challenges to implementing electronic trial data collection in primary care: a qualitative study.

BACKGROUND: Within-consultation recruitment to primary care trials is challenging. Ensuring procedures are efficient and self-explanatory is the key to optimising recruitment. Trial recruitment software that integrates with the electronic health record to support and partially automate procedures is becoming more common. If it works well, such software can support greater participation and more efficient trial designs. An innovative electronic trial recruitment and outcomes software was designed to support recruitment to the Runny Ear randomised controlled trial, comparing topical, oral and delayed antibiotic treatment for acute otitis media with discharge in children. A qualitative evaluation investigated the views and experiences of primary care staff using this trial software. METHODS: Staff were purposively sampled in relation to site, role and whether the practice successfully recruited patients. In-depth interviews were conducted using a flexible topic guide, audio recorded and transcribed. Data were analysed thematically. RESULTS: Sixteen staff were interviewed, including GPs, practice managers, information technology (IT) leads and research staff. GPs wanted trial software that automatically captures patient data. However, the experience of getting the software to work within the limited and complex IT infrastructure of primary care was frustrating and time consuming. Installation was reliant on practice level IT expertise, which varied between practices. Although most had external IT support, this rarely included supported for research IT. Arrangements for approving new software varied across practices and often, but not always, required authorisation from Clinical Commissioning Groups. CONCLUSIONS: Primary care IT systems are not solely under the control of individual practices or CCGs or the National Health Service. Rather they are part of a complex system that spans all three and is influenced by semi-autonomous stakeholders operating at different levels. This led to time consuming and sometimes insurmountable barriers to installation at the practice level. These need to be addressed if software supporting efficient research in primary care is to become a reality.

Decision-making for the infant sleep environment among families with children considered to be at risk of sudden unexpected death in infancy: a systematic review and qualitative metasynthesis.

Background: Advice to families to sleep infants on their backs, avoid smoke exposure, reduce excess bedcovering and avoid specific risks associated with cosleeping has greatly reduced sudden unexpected death in infancy (SUDI) rates worldwide. The fall in rates has not been equal across all groups, and this advice has been less effective for more socially deprived families. Understanding decision-making processes of families with infants at risk would support the development of more effective interventions. Aim: To synthesise the qualitative evidence on parental decision-making for the infant sleep environment among families with children considered to be at increased risk of SUDI. Methods: This study was one of three related reviews of the literature for the Child Safeguarding Practice Review Panel's National Review in England into SUDI in families where the children are considered at risk of harm. A systematic search of eight online databases was carried out in December 2019. Metasynthesis was conducted, with themes extracted from each paper, starting with the earliest publication first. Results: The wider review returned 3367 papers, with 16 papers (across 13 studies) specifically referring to parental decision-making. Six overall themes were identified from the synthesis: (1) knowledge as different from action; (2) external advice must be credible; (3) comfort, convenience and disruption to the routine; (4) plausibility and mechanisms of protection; (5) meanings of safety and risk mitigation using alternative strategies; and (6) parents' own expertise, experience and instincts. Conclusion: Interventions that are intended to improve the uptake of safer sleep advice in families with infants at risk of sleep-related SUDI need to be based on credible advice with mechanisms of protection that are understandable, consistent with other sources, widened to all carers of the infant and fit within the complex practice of caring for infants.

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.

The role of economic, educational and social resources in supporting the use of digital health technologies by people with T2D: a qualitative study.

BACKGROUND: Type 2 Diabetes (T2D) is a common chronic disease, with socially patterned incidence and severity. Digital self-care interventions have the potential to reduce health disparities, by providing personalised low-cost reusable resources that can increase access to health interventions. However, if under-served groups are unable to access or use digital technologies, Digital Health Technologies (DHTs) might make no difference, or worse, exacerbate health inequity. STUDY AIMS: To gain insights into how and why people with T2D access and use DHTs and how experiences vary between individuals and social groups. METHODS: A purposive sample of people with experience of using a DHT to help them self-care for T2D were recruited through diabetes and community groups. Semi-structured interviews were conducted in person and over the phone. Data were analysed thematically. RESULTS: A diverse sample of 21 participants were interviewed. Health care practitioners were not viewed as a good source of information about DHTs that could support T2D. Instead participants relied on their digital skills and social networks to learn about what DHTs are available and helpful. The main barriers to accessing and using DHT described by the participants were availability of DHTs from the NHS, cost and technical proficiency. However, some participants described how they were able to draw on social resources such as their social networks and social status to overcome these barriers. Participants were motivated to use DHTs because they provided self-care support, a feeling of control over T2D, and personalised advice or feedback. The selection of technology was also guided by participants' preferences and what they valued in relation to DHTs and self-care support, and these in turn were influenced by age and gender. CONCLUSION: This research indicates that low levels of digital skills and high cost of digital health interventions can create barriers to the access and use of DHTs to support the self-care of T2D. However, social networks and social status can be leveraged to overcome some of these challenges. If digital interventions are to decrease rather than exacerbate health inequalities, these barriers and facilitators to access and use must be considered when DHTs are developed and implemented.

Digital Health Interventions for People With Type 2 Diabetes to Develop Self-Care Expertise, Adapt to Identity Changes, and Influence Other's Perception: Qualitative Study.

BACKGROUND: A diagnosis of type 2 diabetes (T2D) results in widespread changes to a person's life and can be experienced as an assault on their sense of self. The resources available to an individual influence how the individual adapts to their diabetic identity and subsequently engages in self-care. Digital interventions can be viewed as a resource that people can draw on to adapt to the diagnosis. However, there is an indication that people from disadvantaged groups find digital health technologies more challenging to access and use, which may increase health inequalities. OBJECTIVE: This study aims to gain insights into how and why people with T2D use digital self-care technology and how experiences vary between individuals and social groups. METHODS: A purposive sample of people who had used a digital intervention to help them self-care for their T2D were recruited for the study. Semistructured interviews were conducted, and data were analyzed thematically. RESULTS: A diverse sample of 21 participants were interviewed. Participants used digital interventions to help them to understand and feel more in control of their bodies. Digital interventions were used by participants to project their chosen identity to others. Participants selected technology that allowed them to confirm and enact their preferred positive identities, both by avoiding stigma and by becoming experts in their disease or treatment. Participants preferred using digital interventions that helped them conceal their diabetes, including by buying discrete blood glucose monitors. Some participants used technology to increase their sense of power in their interaction with clinicians, whereas others used technology to demonstrate their goodness. CONCLUSIONS: The technology that people with T2D have access to shapes the way they are able to understand and control their bodies and support preferred social identities.

A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol.

BACKGROUND: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with orally administered antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops, or 'delayed' orally administered antibiotics, could be at least as effective and safe as immediate orally administered antibiotics for children with AOMd. METHODS/DESIGN: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 175 GP practices across the United Kingdom (UK). The study aims to recruit 399 children aged (≥ 12 months and < 16 years) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed orally administered amoxicillin (clarithromycin if penicillin allergic) or immediate orally administered amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow-up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day-14 and at 3 months. DISCUSSION: It is unclear whether prescribing orally administered antibiotics to children with AOMd results in a reduction in symptoms or a shorter duration of illness. The REST trial should allow us to compare the non-inferiority of: immediate topically administered ciprofloxacin ear drops, or delayed orally administered amoxicillin (clarithromycin) against immediate orally administered amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the TRANSFoRm software to randomise participants to the trial will enable recruitment for a relatively uncommon condition. TRIAL REGISTRATION: Name of Registry: ISCRTN Registration Number: ISRCTN12873692. This contains all items required to comply with the World Health Organization Trial Registration Data Set Date of Registration: 24 April 2018 Name of Registry: EudraCT Registration Number: 2017-003635-10 Date of Registration: 6 September 2017.