Antibiotic prescribing rate after optimal near-patient C-reactive protein testing in acutely ill children presenting to ambulatory care (ARON project): protocol for a cluster-randomized pragmatic trial

IntroductionChildren become ill quite often, mainly because of infections, most of which can be managed in the community. Many children are prescribed antibiotics which contributes to antimicrobial resistance and reinforces health-seeking behaviour. Point-of-care C reactive protein (POC CRP) testing, prescription guidance and safety-netting advice can help safely reduce antibiotic prescribing to acutely ill children in ambulatory care as well as save costs at a systems level.Methods and analysisThe ARON (Antibiotic prescribing Rate after Optimal Near-patient testing in acutely ill children in ambulatory care) trial is a pragmatic cluster randomized controlled superiority trial with a nested process evaluation and will assess the clinical and cost effectiveness of a diagnostic algorithm, which includes a standardised clinical assessment, a POC CRP test, and safety-netting advice, in acutely ill children aged 6 months to 12 years presenting to ambulatory care. The primary outcome is antibiotic prescribing at the index consultation; secondary outcomes include clinical recovery, reconsultation, referral/admission to hospital, additional testing, mortality and patient satisfaction. We aim to recruit a total sample size of 6111 patients. All outcomes will be analysed according to the intent-to-treat approach. We will use a mixed-effect logistic regression analysis to account for the clustering at practice level.Ethics and disseminationThe study will be conducted in compliance with the principles of the Declaration of Helsinki (current version), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. Ethics approval for this study was obtained on 10 November 2020 from the Ethics Committee Research of University Hospitals Leuven under reference S62005. We will ensure that the findings of the study will be disseminated to relevant stakeholders other than the scientific world including the public, healthcare providers and policy-makers. The process evaluation that is part of this trial may provide a basis for an implementation strategy. If our intervention proves to be clinically and cost-effective, it will be essential to educate physicians about introducing the diagnostic algorithm including POC CRP testing and safety-netting advice in their daily practice.Trial registration numberClinicalTrials.gov Identifier: NCT04470518. Protocol V.2.0 date 2 October 2020. (Pre-results)

Harnessing the electronic health care record to optimise patient safety in primary care: a framework for evaluating “electronic safety netting” tools (Preprint)

UNSTRUCTURED The management of diagnostic uncertainty is part of every primary care physician’s role. Electronic safety netting (e-safety-netting) tools are designed to assist healthcare professionals in managing diagnostic uncertainty either within or separate to the electronic healthcare record. Using software in addition to verbal and/or paper based safety-netting methods could make the process more rigorous, robust, traceable and auditable. There is no consistent definition or approach to e-safety-netting despite an increasing number of software products identifying as such and being offered to clinical teams, particularly since the COVID-19 pandemic. E-safety-netting tools have developed to perform a variety of functions including clinician alerts, administrative tasking, decision support and triggering reminder text messages to patients. However, these tools have not been evaluated using robust research designs for patient safety interventions. We present a framework of criteria for effective e-safety netting tools, to improve patient safety through more targeted development of software. The framework is based on similar criteria from electronic health record development and principles of patient safety. There are currently no tools available that meet all of the criteria in the framework. When new tools have been developed and validated through robust research, the framework will enable national and local audit and analysis, highlighting differences in performance and presenting potential solutions for improvement. We outline key areas for future research, both in primary care and within integrated care systems. E-safety-netting tools that align with the individual, social and technical aspects of primary care working are more likely to succeed.

Faecal immunochemical test for patients with ‘high-risk’ bowel symptoms: a large prospective cohort study and updated literature review

Background We evaluated whether faecal immunochemical testing (FIT) can rule out colorectal cancer (CRC) among patients presenting with ‘high-risk’ symptoms requiring definitive investigation. Methods Three thousand five hundred and ninety-six symptomatic patients referred to the standard urgent CRC pathway were recruited in a multi-centre observational study. They completed FIT in addition to standard investigations. CRC miss rate (percentage of CRC cases with low quantitative faecal haemoglobin [f-Hb] measurement) and specificity (percentage of patients without cancer with low f-Hb) were calculated. We also provided an updated literature review. Results Ninety patients had CRC. At f-Hb < 10 µg/g, the miss rate was 16.7% (specificity 80.1%). At f-Hb < 4 µg/g, the miss rate was 12.2% (specificity 73%), which became 3.3% if low FIT plus the absence of anaemia and abdominal pain were considered (specificity 51%). Within meta-analyses of 9 UK studies, the pooled miss rate was 7.2% (specificity 74%) for f-Hb < 4 µg/g. Discussion FIT alone as a triage tool would miss an estimated 1 in 8 cases in our study (1 in 14 from meta-analysis), while many people without CRC could avoid investigations. FIT can focus secondary care diagnostic capacity on patients most at risk of CRC, but more work on safety netting is required before incorporating FIT triage into the urgent diagnostic pathway.

Does Safety Netting for Lung Cancer Symptoms Help Patients to Reconsult Appropriately? A Qualitative Study

Background Safety netting in primary care is considered an important intervention for managing diagnostic uncertainty. This is the first study to examine how patients understand and interpret safety netting advice around low-risk potential lung cancer symptoms, and how this affects reconsultation behaviours. Methods Qualitative dyadic interview study in UK primary care. Pre-covid-19, five patients were interviewed face-to-face twice (shortly after a primary care consultation for potential lung cancer symptom(s) and 2–5 months later). The general practitioner (GP) they last saw was interviewed face-to-face once. During the covid-19 pandemic, an additional 15 patients were interviewed once via telephone. Audio-recorded interviews were transcribed verbatim and analysed using a mix of inductive and deductive thematic analysis. Results The findings from our thematic analysis suggest that patients prefer active safety, as part of thorough and logical diagnostic uncertainty management. Passive safety netting may be perceived as dismissive and cause delayed reconsultation. GP safety netting strategies are not always understood, potentially causing patient worry and dissatisfaction. Telephone consultations and the diagnostic overshadowing of COVID-19 on respiratory symptoms impacted GPs’ safety netting strategies and patients’ appetite for active follow up measures. Conclusions Safety netting guidelines do not yet offer solutions that have been proven to promote symptom vigilance and timely reconsultation for low-risk lung cancer symptoms. Patients prefer active safety netting coupled with thorough consultation techniques and a comprehensible diagnostic strategy, and may respond adversely to passive safety netting advice.

Empowering Patients to Self-Manage Common Infections: Qualitative Study Informing the Development of an Evidence-Based Patient Information Leaflet

Common self-limiting infections can be self-managed by patients, potentially reducing consultations and unnecessary antibiotic use. This qualitative study informed by the Theoretical Domains Framework (TDF) aimed to explore healthcare professionals’ (HCPs) and patients’ needs on provision of self-care and safety-netting advice for common infections. Twenty-seven patients and seven HCPs participated in semi-structured focus groups (FGs) and interviews. An information leaflet was iteratively developed and reviewed by participants in interviews and FGs, and an additional 5 HCPs, and 25 patients (identifying from minority ethnic groups) via online questionnaires. Qualitative data were analysed thematically, double-coded, and mapped to the TDF. Participants required information on symptom duration, safety netting, self-care, and antibiotics. Patients felt confident to self-care and were averse to consulting with HCPs unnecessarily but struggled to assess symptom severity. Patients reported seeking help for children or elderly dependents earlier. HCPs’ concerns included patients’ attitudes and a lack of available monitoring of advice given to patients. Participants believed community pharmacy should be the first place that patients seek advice on common infections. The patient information leaflet on common infections should be used in primary care and community pharmacy to support patients to self-manage symptoms and determine when further help is required.

Fifteen-minute consultation: The approach to the febrile child

Febrile children presenting to the emergency department pose unique challenges. This article highlights the importance of identifying children at particular risk of serious bacterial infection (SBI) using risk factors, red flags and appropriate investigations. Emergency clinicians must be aware of the risk factors for SBI in febrile children, including young age, ill-appearing children and those with complex comorbidities or immunodeficiency. The presence of red flags in febrile children should immediately alert concern and prompt senior clinician review. This article also discusses the appropriate use of investigations and their role in complementing clinical assessment. When discharging children home after emergency department assessment, safety netting should be undertaken to ensure parents are aware when to seek further medical opinion. The presence of a prolonged fever of 5 days or longer should alert suspicion and usually requires further investigation.

Factors affecting the documentation of spoken safety-netting advice in routine GP consultations

Background: Previous studies have reported how often safety-netting is documented in medical records, but it is not known how this compares to what is verbalised and what factors might influence the consistency of documentation. Aim: To compare spoken and documented safety-netting advice (SNA) and explore factors associated with documentation. Design and setting: Secondary analysis of GP consultations archive. Method: Observational coding involving classifying and quantifying medical record entries and comparison with spoken SNA in 295 video / audio recorded consultations. Associations were tested using logistic regression. Results: Two-thirds of consultations (192/295) contained spoken SNA which applied to less than half of problems assessed (242/516). Only one-third of consultations (94/295) had documented SNA which covered 20% of problems (105/516). The practice of GPs varied widely from those that did not document their SNA, to those that nearly always did so (86.7%). GPs were more likely to document their SNA for new problems (p=0.030), when only a single problem was discussed in a consultation (p=0.040) and when they gave specific, rather than generic SNA (p=0.007). In consultations where multiple problems were assessed (n=139), the frequency of spoken and documented SNA decreased the later a problem was assessed. Conclusion: GPs frequently do not document safety-netting advice they have given to patients which may have medico-legal implications in the event of an untoward incident. GPs should consider how safely they can assess and document more than one problem in a single consultation and this risk should be shared with patients to help manage expectations.

Diagnostic intervals in oropharyngeal cancers from a primary care perspective: a ten-year case note review

Background Rates of oropharyngeal (OP) cancer are increasing and mortality is related to stage at diagnosis. Early diagnosis is vital to improving patient outcomes.Aim To describe current general practice pathways and time intervals in OP cancer and: a) compare to current National Institute for Health and Care Excellence guidance to refer from general practitioners (GPs) to general medical dentists (dentists); and b) referral pathways for pharyngeal cancers.Design and setting A ten-year retrospective study of patients diagnosed with OP cancer in one suburban general practice in England using GP notes, including secondary care correspondence.Results There were 12 cases of OP cancer; six oral and six pharyngeal. There were marked differences in referral pathways and time intervals for people with visible, or palpable, oral cancers and those with non-visible, or impalpable, pharyngeal cancers. No one had GP to dentist referral. General practice 'safety-netting' or follow-up was not commonly recorded.Conclusion GPs are pivotal in diagnosing symptomatic OP cancers. General practice and dental teams encountering symptoms of uncertain aetiology (for example, pharyngitis) should offer safety-netting to shorten patient intervals to re-attendance. Pathways for oral cancer referral were usually clear and linear. Pathways for pharyngeal cancer were usually complex, with much longer time intervals in primary and secondary care, and would benefit from a single national referral pathway to ENT.