Adaptation and Implementation of a Shared Decision-Making Tool From One Health Context to Another: Partnership Approach Using Mixed Methods.

BACKGROUND: Osteoarthritis is a leading cause of pain and disability. Knee osteoarthritis accounts for nearly four-fifths of the burden of osteoarthritis internationally, and 10% of adults in the United Kingdom have the condition. Shared decision-making (SDM) supports patients to make more informed choices about treatment and care while reducing inequities in access to treatment. We evaluated the experience of a team adapting an SDM tool for knee osteoarthritis and the tool's implementation potential within a local clinical commissioning group (CCG) area in southwest England. The tool aims to prepare patients and clinicians for SDM by providing evidence-based information about treatment options relevant to disease stage. OBJECTIVE: This study aimed to explore the experiences of a team adapting an SDM tool from one health context to another and the implementation potential of the tool in the local CCG area. METHODS: A partnership approach using mixed methods was used to respond to recruitment challenges and ensure that study aims could be addressed within time restrictions. A web-based survey was used to obtain clinicians' feedback on experiences of using the SDM tool. Qualitative interviews were conducted by telephone or video call with a sample of stakeholders involved in adapting and implementing the tool in the local CCG area. Survey findings were summarized as frequencies and percentages. Content analysis was conducted on qualitative data using framework analysis, and data were mapped directly to the Theoretical Domains Framework (TDF). RESULTS: Overall, 23 clinicians completed the survey, including first-contact physiotherapists (11/23, 48%), physiotherapists (7/23, 30%), specialist physiotherapists (4/23, 17%), and a general practitioner (1/23, 4%). Eight stakeholders involved in commissioning, adapting, and implementing the SDM tool were interviewed. Participants described barriers and facilitators to the adaptation, implementation, and use of the tool. Barriers included a lack of organizational culture that supported and resourced SDM, lack of clinician buy-in and awareness of the tool, challenges with accessibility and usability, and lack of adaptation for underserved communities. Facilitators included the influence of clinical leaders' belief that SDM tools can improve patient outcomes and National Health Service resource use, clinicians' positive experiences of using the tool, and improving awareness of the tool. Themes were mapped to 13 of the 14 TDF domains. Usability issues were described, which did not map to the TDF domains. CONCLUSIONS: This study highlights barriers and facilitators to adapting and implementing tools from one health context to another. We recommend that tools selected for adaptation should have a strong evidence base, including evidence of effectiveness and acceptability in the original context. Legal advice should be sought regarding intellectual property early in the project. Existing guidance for developing and adapting interventions should be used. Co-design methods should be applied to improve adapted tools' accessibility and acceptability.

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.

Health Equity in the Effectiveness of Web-Based Health Interventions for the Self-Care of People With Chronic Health Conditions: Systematic Review.

BACKGROUND: Web-based self-care interventions have the potential to reduce health inequalities by removing barriers to access to health care. However, there is a lack of evidence about the equalizing effects of these interventions on chronic conditions. OBJECTIVE: This study investigated the differences in the effectiveness of web-based behavioral change interventions for the self-care of high burden chronic health conditions (eg, asthma, chronic obstructive pulmonary disease [COPD], diabetes, and osteoarthritis) across socioeconomic and cultural groups. METHODS: A systematic review was conducted, following Cochrane review guidelines. We conducted searches in Ovid Medical Literature Analysis and Retrieval System Online and Cumulative Index to Nursing and Allied Health Literature databases. Studies with any quantitative design were included (published between January 1, 2006, and February 20, 2019) if they investigated web-based self-care interventions targeting asthma, COPD, diabetes, and osteoarthritis; were conducted in any high-income country; and reported variations in health, behavior, or psychosocial outcomes across social groups. Study outcomes were investigated for heterogeneity, and the possibility of a meta-analysis was explored. A narrative synthesis was provided together with a novel figure that was developed for this review, displaying heterogeneous outcomes. RESULTS: Overall, 7346 records were screened and 18 studies were included, most of which had a high or critical risk of bias. Important study features and essential data were often not reported. The meta-analysis was not possible due to the heterogeneity of outcomes. There was evidence that intervention effectiveness was modified by participants' social characteristics. Minority ethnic groups were found to benefit more from interventions than majority ethnic groups. Single studies with variable quality showed that those with higher education, who were employed, and adolescents with divorced parents benefited more from interventions. The evidence for differences by age, gender, and health literacy was conflicting (eg, in some instances, older people benefited more, and in others, younger people benefited more). There was no evidence of differences in income, numeracy, or household size. CONCLUSIONS: There was evidence that web-based self-care interventions for chronic conditions can be advantageous for some social groups (ie, minority ethnic groups, adolescents with divorced parents) and disadvantageous for other (ie, low education, unemployed) social groups who have historically experienced health inequity. However, these findings should be treated with caution as most of the evidence came from a small number of low-quality studies. The findings for gender and health literacy were mixed across studies on diabetes, and the findings for age were mixed across studies on asthma, COPD, and diabetes. There was no evidence that income, numeracy, or the number of people living in the household modified intervention effectiveness. We conclude that there appear to be interaction effects, which warrant exploration in future research, and recommend a priori consideration of the predicted interaction effects. TRIAL REGISTRATION: PROSPERO CRD42017056163; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=56163.

Post-consultation illness trajectories in children with acute cough and respiratory tract infection: prospective cohort study.

Background: Little is known about respiratory tract infection (RTI) severity in children following consultation. Objectives: To investigate post-consultation symptom trajectories in children with acute cough and RTI and whether baseline characteristics predict trajectory group. Methods: Prospective cohort study of 2296 children (3 months-16 years) whose parents were invited to report cough severity and duration using a 7-point Likert scale. Longitudinal latent class analysis (LLCA) was used to identify post-consultation symptom trajectories in the first 15 days, and multinomial models to predict class membership. Results: Complete data were available for 1408 children (61%). The best LLCA model identified five post-consultation symptom trajectory groups: 'very rapid recovery' (28.5%), 'rapid recovery' (37.7%), 'intermediate recovery' (18.2%), 'persistent symptoms' (9.5%) and 'initial deterioration with persistent symptoms' (6.0%). Compared with very rapid recovery, parent-reported severe cough in the 24 hours prior to consultation increased the likelihood of rapid recovery (OR 1.79 [95% CI 1.23, 2.60]), intermediate recovery (OR 2.13 [1.38, 3.30] and initial deterioration with persistent symptoms (OR 2.29 [1.26, 4.16]). Initial deterioration was also associated with 'severe barking cough' (OR 3.64 [1.50, 8.82]), 'severely reduced energy in the 24 hours prior to consultation' (OR 3.80 [1.62, 8.87] and higher parent-assessed illness severity at consultation (OR 2.21 [1.17, 4.18]). Conclusion: We identified five distinct symptom trajectory groups showing the majority of children improved post-consultation, with only one group experiencing illness deterioration. The few characteristics associated with group membership did not fall into a pattern that seemed clinically useful.

What gives rise to clinician gut feeling, its influence on management decisions and its prognostic value for children with RTI in primary care: a prospective cohort study.

BACKGROUND: The objectives were to identify 1) the clinician and child characteristics associated with; 2) clinical management decisions following from, and; 3) the prognostic value of; a clinician's 'gut feeling something is wrong' for children presenting to primary care with acute cough and respiratory tract infection (RTI). METHODS: Multicentre prospective cohort study where 518 primary care clinicians across 244 general practices in England assessed 8394 children aged ≥3 months and < 16 years for acute cough and RTI. The main outcome measures were: Self-reported clinician 'gut feeling'; clinician management decisions (antibiotic prescribing, referral for acute admission); and child's prognosis (reconsultation with evidence of illness deterioration, hospital admission in the 30 days following recruitment). RESULTS: Clinician years since qualification, parent reported symptoms (illness severity score ≥ 7/10, severe fever < 24 h, low energy, shortness of breath) and clinical examination findings (crackles/ crepitations on chest auscultation, recession, pallor, bronchial breathing, wheeze, temperature ≥ 37.8 °C, tachypnoea and inflamed pharynx) independently contributed towards a clinician 'gut feeling that something was wrong'. 'Gut feeling' was independently associated with increased antibiotic prescribing and referral for secondary care assessment. After adjustment for other associated factors, gut feeling was not associated with reconsultations or hospital admissions. CONCLUSIONS: Clinicians were more likely to report a gut feeling something is wrong, when they were more experienced or when children were more unwell. Gut feeling is independently and strongly associated with antibiotic prescribing and referral to secondary care, but not with two indicators of poor child health.

Development of an intervention to reduce antibiotic use for childhood coughs in UK primary care using critical synthesis of multi-method research.

BACKGROUND: Overuse of antibiotics contributes to the global threat of antimicrobial resistance. Antibiotic stewardship interventions address this threat by reducing the use of antibiotics in occasions or doses unlikely to be effective. We aimed to develop an evidence-based, theory-informed, intervention to reduce antibiotic prescriptions in primary care for childhood respiratory tract infections (RTI). This paper describes our methods for doing so. METHODS: Green and Krueter's Precede/Proceed logic model was used as a framework to integrate findings from a programme of research including 5 systematic reviews, 3 qualitative studies, and 1 cohort study. The model was populated using a strength of evidence approach, and developed with input from stakeholders including clinicians and parents. RESULTS: The synthesis produced a series of evidence-based statements summarizing the quantitative and qualitative evidence for intervention elements most likely to result in changes in clinician behaviour. Current evidence suggests that interventions which reduce clinical uncertainty, reduce clinician/parent miscommunication, elicit parent concerns, make clear delayed or no-antibiotic recommendations, and provide clinicians with alternate treatment actions have the best chance of success. We designed a web-based within-consultation intervention to reduce clinician uncertainty and pressure to prescribe, designed to be used when children with RTI present to a prescribing clinician in primary care. CONCLUSIONS: We provide a worked example of methods for the development of future complex interventions in primary care, where multiple factors act on multiple actors within a complex system. Our synthesis provided intervention guidance, recommendations for practice, and highlighted evidence gaps, but questions remain about how best to implement these recommendations. The funding structure which enabled a single team of researchers to work on a multi-method programme of related studies (NIHR Programme Grant scheme) was key in our success. TRIAL REGISTRATION: The feasibility study accompanying this intervention was prospectively registered with the ISRCTN registry ( ISRCTN23547970 ), on 27 June 2014.

Throat swabs in children with respiratory tract infection: associations with clinical presentation and potential targets for point-of-care testing.

Background and objectives: Diagnostic uncertainty over respiratory tract infections (RTIs) in primary care contributes to over-prescribing of antibiotics and drives antibiotic resistance. If symptoms and signs predict respiratory tract microbiology, they could help clinicians target antibiotics to bacterial infection. This study aimed to determine relationships between symptoms and signs in children presenting to primary care and microbes from throat swabs. Methods: Cross-sectional study of children ≥3 months to <16 years presenting with acute cough and RTI, with subset follow-up. Associations and area under receiver operating curve (AUROC) statistics sought between clinical presentation and baseline microbe detection. Microbe prevalence compared between baseline (symptomatic) and follow-up (asymptomatic) visits. Results: At baseline, ≥1 bacteria was detected in 1257/2113 (59.5%) children and ≥1 virus in 894/2127 (42%) children. Clinical presentation was not associated with detection of ≥1 bacteria [AUROC 0.54 (95% CI 0.52-0.56)] or ≥1 virus [0.64 (95% CI 0.61-0.66)]. Individually, only respiratory syncytial virus (RSV) was associated with clinical presentation [AUROC 0.80 (0.77-0.84)]. Prevalence fell between baseline and follow-up; more so in viruses (68% versus 26%, P < 0.001) than bacteria (56% versus 40%, P = 0.01); greatest reductions seen in RSV, influenza B and Haemophilus influenzae. Conclusion: Findings demonstrate that clinical presentation cannot distinguish the presence of bacteria or viruses in the upper respiratory tract. However, individual and overall microbe prevalence was greater when children were unwell than when well, providing some evidence that upper respiratory tract microbes may be the cause or consequence of the illness. If causal, selective microbial point-of-care testing could be beneficial.

Inequalities in the Ability for People With Type 2 Diabetes and Prediabetes to Adapt to the Reduction in In-Person Health Support and Increased Use of Digital Support During the COVID-19 Pandemic and Beyond: Qualitative Study.

BACKGROUND: The COVID-19 pandemic created unprecedented challenges for people with type 2 diabetes (T2D) and prediabetes to access in-person health care support. Primary care teams accelerated plans to implement digital health technologies (DHTs), such as remote consultations and digital self-management. There is limited evidence about whether there were inequalities in how people with T2D and prediabetes adjusted to these changes. OBJECTIVE: This study aimed to explore how people with T2D and prediabetes adapted to the reduction in in-person health support and the increased provision of support through DHTs during the COVID-19 pandemic and beyond. METHODS: A purposive sample of people with T2D and prediabetes was recruited by text message from primary care practices that served low-income areas. Semistructured interviews were conducted by phone or video call, and data were analyzed thematically using a hybrid inductive and deductive approach. RESULTS: A diverse sample of 30 participants was interviewed. There was a feeling that primary care had become harder to access. Participants responded to the challenge of accessing support by rationing or delaying seeking support or by proactively requesting appointments. Barriers to accessing health care support were associated with issues with using the total triage system, a passive interaction style with health care services, or being diagnosed with prediabetes at the beginning of the pandemic. Some participants were able to adapt to the increased delivery of support through DHTs. Others had lower capacity to use DHTs, which was caused by lower digital skills, fewer financial resources, and a lack of support to use the tools. CONCLUSIONS: Inequalities in motivation, opportunity, and capacity to engage in health services and DHTs lead to unequal possibilities for people with T2D and prediabetes to self-care and receive care during the COVID-19 pandemic. These issues can be addressed by proactive arrangement of regular checkups by primary care services and improving capacity for people with lower digital skills to engage with DHTs.

Barriers and facilitators to use of digital health tools by healthcare practitioners and their patients, before and during the COVID-19 pandemic: a multimethods study.

OBJECTIVES: To explore how healthcare practitioners (HCPs) made decisions about the implementation of digital health technologies (DHTs) in their clinical practice before and during the COVID-19 pandemic. DESIGN: A multimethods study, comprising semistructured interviews conducted prior to the COVID-19 pandemic, supplemented with an online survey that was conducted during the pandemic with a different sample, to ensure the qualitative findings remained relevant within the rapidly changing healthcare context. Participants were recruited through HCP networks, snowballing and social media. Data were analysed thematically. SETTING: Phone interviews and online survey. PARTICIPANTS: HCPs represented a range of professions from primary and secondary care across England, with varied socioeconomic deprivation. RESULTS: 24 HCPs were interviewed, and 16 HCPs responded to the survey. In the interviews, HCPs described three levels where decisions were made, which determined who would have access to what DHTs: health organisation, HCP and patient levels. These decisions resulted in the unequal implementation of DHTs across health services, created barriers for HCPs using DHTs in their practice and influenced HCPs' decisions on which patients to supply DHTs with. In the survey, HCPs described being provided support to overcome some of the barriers at the organisation and HCP level during the pandemic. However, they cited similar concerns to pre-pandemic about barriers patients faced using DHTs (eg, digital literacy). In the absence of centralised guidance on how to manage these barriers, health services made their own decisions about how to adapt their services for those who struggled with DHTs. CONCLUSIONS: Decision-making at the health organisation, HCP and patient levels influences inequalities in access to DHTs for HCPs and patients. The mobilisation of centralised information and resources during the pandemic can be viewed as good practice for reducing barriers to use of DHTs for HCPs. However, attention must also be paid to reducing barriers to accessing DHTs for patients.

Improving Access to Behavioral Strategies to Improve Mental Well-being With an Entertaining Breakfast Show App: Feasibility Evaluation Study.

BACKGROUND: Although mental ill-health is more prevalent among people from lower socioeconomic groups, digital mental well-being innovations are often developed for people from higher socioeconomic groups, who already have resources to maintain good mental and physical health. To decrease health inequalities and ensure that available solutions are appealing and accessible to people with fewer resources, new approaches should be explored. We developed the app Wakey!, which focused on creating engaging mental health content that is accessible, particularly among lower socioeconomic groups in the United Kingdom. OBJECTIVE: The aim of this study is to assess engagement with the app, investigate initial effectiveness data for 6 well-being outcomes, and explore participants' subjective experiences of using Wakey! METHODS: The app Wakey! was publicly launched on January 20, 2020, and was free to download from Apple Store and Google Play. The app provided its users with entertaining and educational content related to mental well-being. Concurrently, a single-arm mixed methods feasibility trial was carried out from January to April 2020 among people who had downloaded the app and created an account. The primary outcome was engagement, which was collected passively from data logs. Secondary outcome measures were 6 well-being outcomes collected from self-report questionnaires. Individual interviews with 19 app users were carried out in April 2020. RESULTS: In total, 5413 people fit the inclusion criteria and were included in the final sample-65.62% (3520/5364) women, 61.07% (3286/5381) aged between 25 and 44 years, 61.61% (2902/4710) in employment, 8.92% (420/4710) belonging to the lower socioeconomic group, and 8.09% (438/5413) were engaged users. There was no evidence of a difference in engagement regarding sociodemographic and socioeconomic characteristics. There was evidence that users with a higher average daily sleep score, who joined the study more recently, who had higher baseline self-report of sleep quality, and who found episodes more entertaining were more likely to be engaged users. Among 230 users who provided follow-up data, there was evidence of improvements on four of the six well-being outcomes: life satisfaction (P<.001), feeling that life is worthwhile (P=.01), ease of getting up in the morning (P<.001), and self-efficacy (P=.04). The app and its content were well received by those who were interviewed, and several people perceived a positive change in their mental well-being. CONCLUSIONS: This study shows that the app Wakey! could potentially be engaging across different socioeconomic groups, and there is an indication that it could positively impact the mental well-being of those engaged with the app. However, this study was a pragmatic trial with a limited sample, and the selection bias was present in the qualitative and quantitative study. Further work is needed to make any generalizable conclusions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04287296; https://clinicaltrials.gov/ct2/show/NCT04287296.

Prognostic value of upper respiratory tract microbes in children presenting to primary care with respiratory infections: A prospective cohort study.

BACKGROUND: The association between upper respiratory tract microbial positivity and illness prognosis in children is unclear. This impedes clinical decision-making and means the utility of upper respiratory tract microbial point-of-care tests remains unknown. We investigated for relationships between pharyngeal microbes and symptom severity in children with suspected respiratory tract infection (RTI). METHODS: Baseline characteristics and pharyngeal swabs were collected from 2,296 children presenting to 58 general practices in Bristol, UK with acute cough and suspected RTI between 2011-2013. Post-consultation, parents recorded the severity of six RTI symptoms on a 0-6 scale daily for ≤28 days. We used multivariable hurdle regression, adjusting for clinical characteristics, antibiotics and other microbes, to investigate associations between respiratory microbes and mean symptom severity on days 2-4 post-presentation. RESULTS: Overall, 1,317 (57%) children with complete baseline, microbiological and symptom data were included. Baseline characteristics were similar in included participants and those lacking microbiological data. At least one virus was detected in 869 (66%) children, and at least one bacterium in 783 (60%). Compared to children with no virus detected (mean symptom severity score 1.52), adjusted mean symptom severity was 0.26 points higher in those testing positive for at least one virus (95% CI 0.15 to 0.38, p<0.001); and was also higher in those with detected Influenza B (0.44, 0.15 to 0.72, p = 0.003); RSV (0.41, 0.20 to 0.60, p<0.001); and Influenza A (0.25, -0.01 to 0.51, p = 0.059). Children positive for Enterovirus had a lower adjusted mean symptom severity (-0.24, -0.43 to -0.05, p = 0.013). Children with detected Bordetella pertussis (0.40, 0.00 to 0.79, p = 0.049) and those with detected Moraxella catarrhalis (-0.76, -1.06 to -0.45, p<0.001) respectively had higher and lower mean symptom severity compared to children without these bacteria. CONCLUSIONS: There is a potential role for upper respiratory tract microbiological point-of-care tests in determining the prognosis of childhood RTIs.

Parental and clinician agreement of illness severity in children with RTIs: secondary analysis of data from a prospective cohort study.

BACKGROUND: Severity assessments of respiratory tract infection (RTI) in children are known to differ between parents and clinicians, but determinants of perceived severity are unknown. AIM: To investigate the (dis)agreement between, and compare the determinants of, parent and clinician severity scores. DESIGN AND SETTING: Secondary analysis of data from a prospective cohort study of 8394 children presenting to primary care with acute (≤28 days) cough and RTI. METHOD: Data on sociodemographic factors, parent-reported symptoms, clinician-reported findings, and severity assessments were used. Kappa (κ)-statistics were used to investigate (dis) agreement, whereas multivariable logistic regression was used to identify the factors associated with illness severity. RESULTS: Parents reported higher illness severity (mean 5.2 [standard deviation (SD) 1.8], median 5 [interquartile range (IQR) 4-7]), than clinicians (mean 3.1 [SD 1.7], median 3 [IQR 2-4], P<0.0001). There was low positive correlation between these scores (+0.43) and poor inter-rater agreement between parents and clinicians (κ 0.049). The number of clinical signs was highly correlated with clinician scores (+0.71). Parent-reported symptoms (in the previous 24 hours) that were independently associated with higher illness severity scores, in order of importance, were: severe fever, severe cough, rapid breathing, severe reduced eating, moderate-to-severe reduced fluid intake, severe disturbed sleep, and change in cry. Three of these symptoms (severe fever, rapid breathing, and change in cry) along with inter/subcostal recession, crackles/crepitations, nasal flaring, wheeze, and drowsiness/irritability were associated with higher clinician scores. CONCLUSION: Clinicians and parents use different factors and make different judgements about the severity of children's RTI. Improved understanding of the factors that concern parents could improve parent-clinician communication and consultation outcomes.

Impact of antibiotics for children presenting to general practice with cough on adverse outcomes: secondary analysis from a multicentre prospective cohort study.

BACKGROUND: Clinicians commonly prescribe antibiotics to prevent major adverse outcomes in children presenting in primary care with cough and respiratory symptoms, despite limited meaningful evidence of impact on these outcomes. AIM: To estimate the effect of children's antibiotic prescribing on adverse outcomes within 30 days of initial consultation. DESIGN AND SETTING: Secondary analysis of 8320 children in a multicentre prospective cohort study, aged 3 months to <16 years, presenting in primary care across England with acute cough and other respiratory symptoms. METHOD: Baseline clinical characteristics and antibiotic prescribing data were collected, and generalised linear models were used to estimate the effect of antibiotic prescribing on adverse outcomes within 30 days (subsequent hospitalisations and reconsultation for deterioration), controlling for clustering and clinicians' propensity to prescribe antibiotics. RESULTS: Sixty-five (0.8%) children were hospitalised and 350 (4%) reconsulted for deterioration. Clinicians prescribed immediate and delayed antibiotics to 2313 (28%) and 771 (9%), respectively. Compared with no antibiotics, there was no clear evidence that antibiotics reduced hospitalisations (immediate antibiotic risk ratio [RR] 0.83, 95% confidence interval [CI] = 0.47 to 1.45; delayed RR 0.70, 95% CI = 0.26 to 1.90, overall P = 0.44). There was evidence that delayed (rather than immediate) antibiotics reduced reconsultations for deterioration (immediate RR 0.82, 95% CI = 0.65 to 1.07; delayed RR 0.55, 95% CI = 0.34 to 0.88, overall P = 0.024). CONCLUSION: Most children presenting with acute cough and respiratory symptoms in primary care are not at risk of hospitalisation, and antibiotics may not reduce the risk. If an antibiotic is considered, a delayed antibiotic prescription may be preferable as it is likely to reduce reconsultation for deterioration.

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.

Development and internal validation of a clinical rule to improve antibiotic use in children presenting to primary care with acute respiratory tract infection and cough: a prognostic cohort study.

BACKGROUND: Antimicrobial resistance is a serious threat to public health, with most antibiotics prescribed in primary care. General practitioners (GPs) report defensive antibiotic prescribing to mitigate perceived risk of future hospital admission in children with respiratory tract infections. We developed a clinical rule aimed to reduce clinical uncertainty by stratifying risk of future hospital admission. METHODS: 8394 children aged between 3 months and 16 years presenting with acute cough (for ≤28 days) and respiratory tract infection were recruited to a prognostic cohort study from 247 general practitioner practices in England. Exposure variables included demographic characteristics, parent-reported symptoms, and physical examination signs. The outcome was hospital admission for respiratory tract infection within 30 days, collected using a structured, blinded review of medical records. FINDINGS: 8394 (100%) children were included in the analysis, with 78 (0·9%, 95% CI 0·7%-1·2%) admitted to hospital: 15 (19%) were admitted on the day of recruitment (day 1), 33 (42%) on days 2-7; and 30 (39%) on days 8-30. Seven characteristics were independently associated (p<0·01) with hospital admission: age <2 years, current asthma, illness duration of 3 days or less, parent-reported moderate or severe vomiting in the previous 24 h, parent-reported severe fever in the previous 24 h or a body temperature of 37·8°C or more at presentation, clinician-reported intercostal or subcostal recession, and clinician-reported wheeze on auscultation. The area under the receiver operating characteristic (AUROC) curve for the coefficient-based clinical rule was 0·82 (95% CI 0·77-0·87, bootstrap validated 0·81). Assigning one point per characteristic, a points-based clinical rule consisting of short illness, temperature, age, recession, wheeze, asthma, and vomiting (mnemonic STARWAVe; AUROC 0·81, 0·76-0·85) distinguished three hospital admission risk strata: very low (0·3%, 0·2-0·4%) with 1 point or less, normal (1·5%, 1·0-1·9%) with 2 or 3 points, and high (11·8%, 7·3-16·2%) with 4 points or more. INTERPRETATION: Clinical characteristics can distinguish children at very low, normal, and high risk of future hospital admission for respiratory tract infection and could be used to reduce antibiotic prescriptions in primary care for children at very low risk. FUNDING: National Institute for Health Research (NIHR).

The CHICO (Children's Cough) Trial protocol: a feasibility randomised controlled trial investigating the clinical and cost-effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection.

INTRODUCTION: While most respiratory tract infections (RTIs) will resolve without treatment, many children will receive antibiotics and some will develop severe symptoms requiring hospitalisation. There have been calls for evidence to reduce uncertainty regarding the identification of children who will and will not benefit from antibiotics. The aim of this feasibility trial is to test recruitment and the acceptance of a complex behavioural intervention designed to reduce antibiotic prescribing, and to inform how best to conduct a larger trial. METHODS AND ANALYSIS: The CHICO (Children's Cough) trial is a single-centre feasibility cluster randomised controlled trial (RCT) comparing a web-based, within-consultation, behavioural intervention with usual care for children presenting to general practitioner practices with RTI and acute cough. The trial aims to recruit at least 300 children between October 2014 and April 2015, in a single area in South West England. Following informed consent, demographic information will be recorded, and symptoms and signs measured. Parents/carers of recruited children will be followed up on a weekly basis to establish symptom duration, resource use and cost of the illness to the parent until the child's cough has resolved or up to 8 weeks, whichever occurs earlier. A review of medical notes, including clinical history, primary care reconsultations and hospitalisations will be undertaken 2 months after recruitment. The trial feasibility will be assessed by: determining acceptability of the intervention to clinicians and parent/carers; quantifying differential recruitment and follow-up; determining intervention fidelity; the success in gathering the data necessary to conduct a cost-effectiveness analysis; and collecting data about antibiotic prescribing rates to inform the sample size needed for a fully powered RCT. ETHICS AND DISSEMINATION: The study was approved by the North West-Haydock Research Ethics Committee, UK (reference number: 14/NW/1034). The findings from this feasibility trial will be disseminated through research conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN23547970.