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Abstract Background Antimicrobial resistance is a global patient safety priority and inappropriate antimicrobial use is a key contributing factor. Evidence have shown that delayed (back-up) antibiotic prescriptions (DP) are an effective and safe strategy for reducing unnecessary antibiotic consumption but its use is controversial. Methods We conducted a realist review to ask why, how, and in what contexts general practitioners (GPs) use DP. We searched five electronic databases for relevant articles and included DP-related data from interviews with healthcare professionals in a related study. Data were analysed using a realist theory-driven approach – theorising which context(s) influenced (mechanisms) resultant outcome(s) (context-mechanism-outcome-configurations: CMOCs). Results Data were included from 76 articles and 41 interviews to develop a program theory comprising nine key and 56 related CMOCs. These explain the reasons for GPs’ tolerance of risk to different uncertainties and how these may interact with GPs’ work environment, self-efficacy and perceived patient concordance to make using DP as a safety-net or social tool more or less likely, at a given time-point. For example, when a GP uses clinical scores or diagnostic tests: a clearly high or low score/test result may mitigate scientific uncertainty and lead to an immediate or no antibiotic decision; an intermediary result may provoke hermeneutic (interpretation-related) uncertainty and lead to DP becoming preferred and used as a safety net. Our program theory explains how DP can be used to mitigate some uncertainties but also provoke or exacerbate others. Conclusion This review explains how, why and in what contexts GPs are more or less likely to use DP, as well as various uncertainties GPs face which DP may mitigate or provoke. We recommend that efforts to plan and implement interventions to optimise antibiotic prescribing in primary care consider these uncertainties and the contexts when DP may be (dis)preferred over other interventions to reduce antibiotic prescribing. We also recommend the following and have included example activities for: (i) reducing demand for immediate antibiotics; (ii) framing DP as an ‘active’ prescribing option; (iii) documenting the decision-making process around DP; and (iv) facilitating social and system support.

Abstract Background Use of electronic health records (EHR) to provide real-world data for research is established, but using EHR to deliver randomised controlled trials (RCTs) more efficiently is less developed. The Allergy AntiBiotics And Microbial resistAnce (ALABAMA) RCT evaluated a penicillin allergy assessment pathway versus usual clinical care in a UK primary care setting. The aim of this paper is to describe how EHRs were used to facilitate efficient delivery of a large-scale randomised trial of a complex intervention embracing efficient participant identification, supporting minimising GP workload, providing accurate post-intervention EHR updates of allergy status, and facilitating participant follow up and outcome data collection. The generalisability of the EHR approach and health economic implications of EHR in clinical trials will be reported in the main ALABAMA trial cost-effectiveness analysis. Methods A descriptive account of the adaptation of functionality within SystmOne used to deliver/facilitate multiple trial processes from participant identification to outcome data collection. Results An ALABAMA organisation group within SystmOne was established which allowed sharing of trial functions/materials developed centrally by the research team. The ‘ALABAMA unit’ within SystmOne was also created and provided a secure efficient environment to access participants’ EHR data. Processes of referring consented participants, allocating them to a trial arm, and assigning specific functions to the intervention arm were developed by adapting tools such as templates, reports, and protocols which were already available in SystmOne as well as pathways to facilitate allergy de-labelling processes and data retrieval for trial outcome analysis. Conclusions ALABAMA is one of the first RCTs to utilise SystmOne EHR functionality and data across the RCT delivery, demonstrating feasibility and applicability to other primary care RCTs. Trial registration ClinicalTrials.gov: NCT04108637, registered 05/03/2019. ISRCTN: ISRCTN20579216.

Abstract Background Tuberculosis (TB) is a stigmatised disease with intersectional associations with poverty, HIV, transmission risk and mortality. The use of visible TB infection prevention and control (IPC) measures, such as masks or isolation, can contribute to stigma. Methods To explore stigma in this condition, we conducted in-depth individual interviews with 18 health workers and 15 patients in the rural Eastern Cape of South Africa using a semi-structured interview guide and narrative approach. We used reflexive thematic analysis guided by line-by-line coding. We then interpreted these key findings using Link and Phelan’s theoretical model of stigma, related this to stigma mitigation recommendations from participants and identified levels of intervention with the Health Stigma and Discrimination Framework. Results Participants shared narratives of how TB IPC measures can contribute to stigma, with some describing feeling ‘less than human’. We found TB IPC measures sometimes exacerbated stigma, for example through introducing physical isolation that became prolonged or through a mask marking the person out as being ill with TB. In this context, stigma emerged from the narrow definition of what mask-wearing symbolises, in contrast with broader uses of masks as a preventative measure. Patient and health workers had contrasting perspectives on the implications of TB IPC-related stigma, with patients focussing on communal benefit, while health workers focussed on the negative impact on the health worker-patient relationship. Participant recommendations to mitigate TB IPC-related stigma included comprehensive information on TB IPC measures, respectful communication between health workers and patients, shifting the focus of TB IPC messages to communal safety (which could draw on ubuntu, a humanist framework) and using universal IPC precautions instead of measures targeted at someone with infectious TB. Conclusions Health facilities may unwittingly perpetuate stigma through TB IPC implementation, but they also have the potential to reduce it. Evoking ‘ubuntu’ as an African humanist conceptual framework could provide a novel perspective to guide future TB IPC stigma mitigation interventions, including policy changes to universal IPC precautions.

BackgroundSepsis is a common cause of serious illness and death. Sepsis management remains challenging and suboptimal. To support rapid sepsis diagnosis and treatment, screening tools have been embedded into hospital digital systems to appear as digital alerts. The implementation of digital alerts to improve the management of sepsis and deterioration is a complex intervention that has to fit with team workflow and the views and practices of hospital staff. Despite the importance of human decision-making and behavior in optimal implementation, there are limited qualitative studies that explore the views and experiences of health care professionals regarding digital alerts as sepsis or deterioration computerized clinician decision support systems (CCDSSs). ObjectiveThis study aims to explore the views and experiences of health care professionals on the use of sepsis or deterioration CCDSSs and to identify barriers and facilitators to their implementation and use in National Health Service (NHS) hospitals. MethodsWe conducted a qualitative, multisite study with unstructured observations and semistructured interviews with health care professionals from emergency departments, outreach teams, and intensive or acute units in 3 NHS hospital trusts in England. Data from both interviews and observations were analyzed together inductively using thematic analysis. ResultsA total of 22 health care professionals were interviewed, and 12 observation sessions were undertaken. A total of four themes regarding digital alerts were identified: (1) support decision-making as nested in electronic health records, but never substitute professionals’ knowledge and experience; (2) remind to take action according to the context, such as the hospital unit and the job role; (3) improve the alerts and their introduction, by making them more accessible, easy to use, not intrusive, more accurate, as well as integrated across the whole health care system; and (4) contextual factors affecting views and use of alerts in the NHS trusts. Digital alerts are more optimally used in general hospital units with a lower senior decision maker:patient ratio and by health care professionals with experience of a similar technology. Better use of the alerts was associated with quality improvement initiatives and continuous sepsis training. The trusts’ features, such as the presence of a 24/7 emergency outreach team, good technological resources, and staffing and teamwork, favored a more optimal use. ConclusionsTrust implementation of sepsis or deterioration CCDSSs requires support on multiple levels and at all phases of the intervention, starting from a prego-live analysis addressing organizational needs and readiness. Advancements toward minimally disruptive and smart digital alerts as sepsis or deterioration CCDSSs, which are more accurate and specific but at the same time scalable and accessible, require policy changes and investments in multidisciplinary research.

Objectives To provide an overview of patient and public involvement (PPI) in the mesolevel and macrolevel of healthcare (different from PPI in research) and identify directions for future research by mapping contexts, terminology, conceptual frameworks, measured outcomes and research gaps.Design Mapping review of systematic reviews. A patient coresearcher (JB) was involved in all stages. A broad search strategy was applied to capture the variation in terminology.Data sources MEDLINE, CINAHL and PsycINFO were searched from 1 January 2001 to 5 December 2022.Eligibility criteria We included systematic reviews of empirical studies focusing on PPI in the mesolevel and macrolevel of healthcare.Data extraction and synthesis Three independent reviewers used standardised methods to screen studies and extract data. Thematic categories were created inductively through iteration. The results were organised in narrative, visual or tabular formats.Results 4419 identified records were screened. 37 systematic reviews were eligible for inclusion. Most studies were narrative syntheses (N=26). Identified context categories were PPI for healthcare quality improvement (22%), patient safety (8%), community-based initiatives (27%), peer support (16 %) and education of healthcare professionals (27%). A wide range of terms was used to discuss PPI, with community participation being the most common. 28 reviews reported on frameworks, conceptual guidance and/or policy documents. Nine different types of outcomes were identified. The research gap pointed out most frequently is the lack of studies of robust designs that allow for replication and long-term follow-up, followed by studies on cost-effectiveness and resources needed. There is a need for consensus on the use of terminology.Conclusions This mapping review sheds light on the evolving landscape of PPI in healthcare. To advance the field, future research should prioritise rigorous study designs, cost-effectiveness assessments and consensus-building efforts to create a more unified and impactful approach for PPI in healthcare.

Background Despite climate change being described as a code red for humanity, health systems have been particularly slow in both climate mitigation and adaptation responses. The effects of climate change on health and health systems will not be felt equally, with underserved and marginalised communities disproportionately impacted. The circumpolar region is warming at 3–4 times the global rate, amplifying already existing socioeconomic barriers and health inequities, with particular amplified effects for the substantial Indigenous population in the area.Objectives and setting We therefore sought to explore perspectives of physicians around patient-planetary health (P-PH) co-benefit prescribing in a circumpolar region in the Northwest Territories (NWT), Canada, known to be one of the ground zero levels for climate change.Methods Thirteen semi-structured physician interviews were carried out in the NWT region between May 2022 and March 2023 using purposive sampling. Interviews were transcribed verbatim and reflexive thematic analysis was carried out to identify key themes.Results There were three main themes identified including (1) current healthcare system does not support planetary health, (2) supporting patient-planetary health is currently difficult for clinicians and (3) considering change in the NWT to support patient-planetary health. Participants noted key opportunities to move planetary health forward, with the NWT having the potential to be an innovative model for planetary health-informed change for other health systems.Conclusion The NWT health system has unique features due to its rural and remote nature and smaller population base. Despite this, our study identified some key opportunities for advancing P-PH co-benefit efforts. The identified opportunities may be considered in future intervention, organisational change and policy-making efforts with potential relevance in other settings.

AbstractBackground Access to testing during the first wave of the COVID-19 pandemic was limited, impacting patients with COVID-19-like symptoms. Current qualitative studies have been limited to one country or were conducted outside Europe.Objectives To explore - in eight European countries - the experiences of patients consulting in primary care with COVID-19-like symptoms during the first wave of the pandemic.Methods Sixty-six semi-structured interviews, informed by a topic guide, were conducted by telephone or in person between April and July 2020. Patients with COVID-19-like symptoms were purposively recruited in primary care sites in eight countries and sampled based on age, gender, and symptom presentation. Deductive and inductive thematic analysis techniques were used to develop a framework representing data across settings. Data adequacy was attained by collecting rich data.Results Seven themes were identified, which described the experiences of patients consulting. Two themes are reported in this manuscript describing the role of COVID-19 testing in this experience. Patients described significant distress due to their symptoms, especially those at higher risk of complications from COVID-19, and those with severe symptoms. Patients wanted access to testing to identify the cause of their illness and minimise the burden of managing uncertainty. Some patients testing positive for COVID-19 assumed they would be immune from future infection.Conclusion Patients experiencing novel and severe symptoms, particularly those with comorbidities, experienced a significant emotional and psychological burden due to concerns about COVID-19. Testing provided reassurance over health status and helped patients identify which guidance to follow. Testing positive for SARS-CoV-2 led to some patients thinking they were immune from future infection, thus influencing subsequent behaviour.

Objectives: Penicillin allergy records are often incorrect and may result in harm. We aimed to systematically review the effectiveness and safety of nonallergist health care worker delivery of penicillin allergy delabeling. Methods: We searched EMBASE/MEDLINE/CINAHL (Ovid), PsycInfo, Web of Science, and Cochrane CENTRAL from inception to January 21, 2022 and unpublished studies and gray literature. The proportion of patients allergic to penicillin delabeled and harmed was calculated using random-effects models. Results: Overall, 5019 patients were delabeled. Using allergy history alone, 14% (95% confidence interval [CI], 9-21%) of 4350 assessed patients were delabeled without reported harm. Direct drug provocation testing resulted in delabeling in 27% (95% CI, 18-37%) of 4207 assessed patients. Of the 1373 patients tested, 98% were delabeled (95% CI, 97-99%), and nonserious harm was reported in 1% (95% CI, 0-2%). Using skin testing, followed by drug provocation testing, 41% (95% CI, 24-59%) of 2890 assessed patients were delabeled. Of the 1294 tested patients, 95.0% (95% CI, 90-99%) were delabeled, and the reported harm was low (0%; (95% CI 0-1%). Conclusion: Penicillin allergy delabeling by nonallergists is efficacious and safe. The proportion of assessed patients who can be delabeled increases with the complexity of testing method, but substantial numbers can be delabeled without skin testing.

Background: In England, clinical commissioning group (CCG; now replaced by Integrated Care Systems [ICSs]) and primary care network (PCN) professionals support primary care prescribers to optimise antimicrobial stewardship (AMS). Aim: To explore views and experiences of CCG and PCN staff in supporting AMS, and the impact of COVID-19 on this support. Design & setting: Qualitative interview study in primary care in England. Method: Semi-structured interviews with staff from CCG and PCNs responsible for AMS were conducted at two timepoints via telephone. These were audio-recorded, transcribed, and analysed thematically. Results: Twenty-seven interviews were conducted with 14 participants (nine CCG, five PCN) in December 2020–January 2021 and February–May 2021. The study found that AMS support was (1) deprioritised in order to keep general practice operational and deliver COVID-19 vaccines; (2) disrupted as social distancing made it harder to build relationships, conduct routine AMS activities, and challenge prescribing decisions; and (3) adapted, with opportunities identified for greater use of technology and changing patient and public perceptions of viruses and self-care. It was also found that resources to support AMS were valued if they were both novel, to counter AMS ‘fatigue’, and sufficiently familiar to fit with existing and/or future AMS. Conclusion: AMS needs to be reprioritised in general practice in the post-pandemic era and within the new ICSs in England. This should include interventions and strategies that combine novel elements with already familiar strategies to refresh prescribers’ motivation and opportunities for AMS. Behaviour change interventions should be aimed at improving the culture and processes for how PCN pharmacists voice concerns about AMS to prescribers in general practice and take advantage of the changed patient and public perceptions of viruses and self-care.

Introduction Incorrect penicillin allergy records are recognised as an important barrier to the safe treatment of infection and affect an estimated 2.7 million people in England. Penicillin allergy records are associated with worse health outcome and antimicrobial resistance. The ALlergy AntiBiotics And Microbial resistAnce (ALABAMA) trial aims to determine if an intervention package, centred around a penicillin allergy assessment pathway (PAAP) initiated in primary care, is safe and effective in improving patient health outcomes and antibiotic prescribing.Methods and analysis The ALABAMA trial is a multicentre, parallel-arm, open-label, randomised pragmatic trial with a nested pilot study. Adults (≥18 years) with a penicillin allergy record and who have received antibiotics in the previous 24 months will be eligible for participation. Between 1592 and 2090 participants will be recruited from participating National Health Service general practices in England. Participants will be randomised to either usual care or intervention to undergo a pre-emptive PAAP using a 1:1 allocation ratio. The primary outcome measure is the percentage of treatment response failures within 28 days of an index prescription. 2090 and 1592 participants are estimated to provide 90% and 80% power, respectively, to detect a clinically important absolute difference of 7.9% in primary outcome at 1 year between groups. The trial includes a mixed-methods process evaluation and cost-effectiveness evaluation.Ethics and dissemination This trial has been approved by London Bridge Research Ethics Committee (ref: 19/LO/0176). It will be conducted in compliance with Good Clinical Practice guidelines according to the Declaration of Helsinki. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to an international, peer-reviewed journal.Trial registration ISRCTN20579216.

BackgroundThe majority of antibiotics are prescribed in primary care for respiratory tract infections. Point-of-care tests (POCTs) for the management of community-acquired acute respiratory tract infections (CA-ARTI) have been developed to help optimize antibiotic prescribing. While some countries in Europe have adopted these tests in primary care settings, most have not. Stakeholders, such as policy-makers, regulators, the diagnostic industry, and scientific associations, have roles in the implementation of new diagnostics in primary care. The aim of this study is to explore these stakeholders’ views and experiences, and identify areas of unmet need relating to POCT implementation.MethodsStakeholders were recruited using purposive sampling and snowballing. Between March 2021 and May 2022, semi-structured interviews were conducted online with stakeholders in Belgium, the UK and from European Union (EU) -level organizations. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed inductively and deductively using thematic analysis.ResultsTwenty-six stakeholders participated: eleven from EU-level organizations, seven from Belgium, and eight from the UK. Five themes were identified. Stakeholders felt a balance of top-down and bottom-up approaches were an optimal strategy to the implementation of POCTs. Stakeholders stressed the need to engage with clinicians to act as champions for tests to help raise awareness and generate new evidence on how tests are used. While acknowledging the potential of POCTs for improving patient outcomes and impacting antibiotic prescribing behavior, some raised concerns on how tests would be used in practice and wished to see national data on effectiveness. COVID-19 catalyzed the use of tests, but stakeholders were pessimistic that processes for approving diagnostics during the pandemic would be replicated in the future.ConclusionStakeholders provided recommendations for research and practice. Robust reimbursement policies could alleviate financial burden from clinicians and patients, encouraging practices to adopt POCTs. Industry is likely to benefit from engaging as early on as possible with other stakeholders. Due to uncertainty among stakeholders on the impact of POCTs on antibiotic prescribing, further evidence is needed to understand how practices adopt POCTs and the implications for stewardship. Monitoring how POCTs are used can inform future guidelines on successful diagnostic implementation.

Background: Antibiotic treatment duration may be longer than sometimes needed. Stopping antibiotics early, rather than completing pre-set antibiotic courses, may help reduce unnecessary exposure to antibiotics and antimicrobial resistance (AMR). Aim: To identify clinicians' and patients' views on stopping antibiotics when better (SAWB) for urinary tract infections (UTIs), and to explore comparisons with other acute infections. Design & setting: An exploratory qualitative study with general practice clinicians and patients in England. Method: Primary care clinicians and patients who had recent UTI experience were recruited in England. Remote one-to-one interviews with clinicians and patients, and one focus group with patients, were conducted. Data were audiorecorded, transcribed, and analysed thematically. Results: Eleven clinicians (seven GPs) and 19 patients (14 with experience of recurrent and/or chronic UTIs) were included. All participants considered SAWB unfamiliar and contradictory to well-known advice to complete antibiotic courses, but were interested in the evidence for risks and benefits of SAWB. Clinicians were amenable if evidence and guidelines supported it, whereas patients were more averse because of concerns about the risk of UTI recurrence and/or complications and AMR. Participants viewed SAWB as potentially more appropriate for longer antibiotic courses and other infections (with longer courses and lower risk of recurrence and/or complications). Participants stressed the need for unambiguous advice and SAWB as part of shared decision making and personalised advice. Conclusion: Patients were less accepting of SAWB, whereas clinicians were more amenable to it. Patients and clinicians require good evidence that this novel approach to self-determining antibiotic duration is safe and beneficial. If evidence based, SAWB should be offered with an explanation of why the advice differs from the ‘complete the course’ instruction, and a clear indication of when exactly to stop antibiotics should be given.

Abstract Background Opportunistic recruitment in primary care is challenging due to the inherent unpredictability of incident conditions, and workload and time pressures. Many clinical trials do not recruit to target, leading to equivocal answers to research questions. Learning from the experiences of patients and recruiters to trials of incident conditions has the potential to improve recruitment and retention to future trials, thereby enhancing the quality and impact of research findings. The aim of this research was to learn from the trial experiences of UTI patients and recruiters to the Cranberry for UTI (CUTI) trial, to help plan an adequately powered trial of similar design. Methods One-to-one semi-structured interviews were embedded within the CUTI feasibility trial, an open-label, randomised feasibility trial of cranberry extract for symptoms of acute, uncomplicated Urinary Tract Infection (UTI) in primary care. Interviews were conducted with a sample of: CUTI trial participants; non-CUTI trial UTI patients; and, recruiters to the CUTI trial. Verbatim transcripts were analysed thematically. Results Twenty-six patients with UTI and eight recruiters (nurses and GPs) to the CUTI trial were interviewed. Three themes were developed around: reasons for participating in research; barriers to opportunistic recruitment; and, UTI patients’ experiences of trial procedures. Recruiters found that targeted electronic prompts directed at healthcare practitioners based in clinics where patients with incident conditions were likely to present (e.g. minor illness clinic) were more effective than generic prompts (e.g. desk prompts) at filtering patients from their usual clinical pathway to research clinics. Using a script to explain the delayed antibiotic trial group to patients was found to be helpful, and may have served to boost recruitment. For UTI patients, using an electronic diary to rate their symptoms was considered an acceptable medium, and often preferable to using a paper diary or mobile phone application. Conclusions The use of targeted prompts directed at clinicians, a script to explain trial groups that may be deemed less desirable, and an appropriate diary format for patient-reported outcomes, may help to improve trial recruitment and retention.

Abstract Current methods to assess asthma and guide inhaled corticosteroid (ICS) dose titration mainly centre on patient-reported symptoms and lung function assessments. However, these methods correlate only weakly with airway inflammation making them unreliable predictors of future exacerbations and ICS requirement. Fractional Exhaled Nitric Oxide (FeNO) is a simple non-invasive objective measure of airways inflammation used predominantly in specialist clinics. Previous qualitative studies have mainly focused on the acceptability of FeNO in secondary care and there is limited insight to support clinicians and patients using FeNO in primary care asthma reviews. This study aimed to explore adult patient with asthma and primary care health care professional (HCP) views on introducing FeNO as part of routine asthma reviews. Twenty-three health care professionals and 22 patients were interviewed over the phone or online. Both groups reported that current asthma reviews are often seen as tick-box exercises and that introducing the FeNO test would make reviews more tailored to the individual patient, rather than relying on subjective patient reports of asthma control. Adults with asthma also highlighted support more open communication and their understanding of asthma, as they desired to feel more engaged in decisions and conversations about their asthma. HCPs reported valuing patient education and empowerment over a paternalistic approach, when time and resources allow. They also recognised FeNO to provide an objective measure of inflammation that could support them in the education and empowerment of patients. FeNO was seen by both groups as a potentially valuable addition to current asthma reviews mainly led by nurses, both for increasing their understanding of current risk of exacerbation and also to provide more tailored and personalised asthma management to patients. Our findings highlighted the need for open and clear communication about how to interpret FeNO results.

Abstract Background Trials show that antimicrobial stewardship (AMS) strategies, including communication skills training, point-of-care C-reactive protein testing (POC-CRPT) and delayed prescriptions, help optimise antibiotic prescribing and use in primary care. However, the use of these strategies in general practice is limited and inconsistent. We aimed to develop an intervention to enhance uptake and implementation of these strategies in primary care. Methods We drew on the Person-Based Approach to develop an implementation intervention in two stages. (1) Planning and design: We defined the problem in behavioural terms drawing on existing literature and conducting primary qualitative research (nine focus groups) in high-prescribing general practices. We identified ‘guiding principles’ with intervention objectives and key features and developed logic models representing intended mechanisms of action. (2) Developing the intervention: We created prototype intervention materials and discussed and refined these with input from 13 health professionals and 14 citizens in two sets of design workshops. We further refined the intervention materials following think-aloud interviews with 22 health professionals. Results Focus groups highlighted uncertainties about how strategies could be used. Health professionals in the workshops suggested having practice champions, brief summaries of each AMS strategy and evidence supporting the AMS strategies, and they and citizens gave examples of helpful communication strategies/phrases. Think-aloud interviews helped clarify and shorten the text and user journey of the intervention materials. The intervention comprised components to support practice-level implementation: antibiotic champions, practice meetings with slides provided, and an ‘implementation support’ website section, and components to support individual-level uptake: website sections on each AMS strategy (with evidence, instructions, links to electronic resources) and material resources (patient leaflets, POC-CRPT equipment, clinician handouts). Conclusions We used a systematic, user-focussed process of developing a behavioural intervention, illustrating how it can be used in an implementation context. This resulted in a multicomponent intervention to facilitate practice-wide implementation of evidence-based strategies which now requires implementing and evaluating. Focusing on supporting the uptake and implementation of evidence-based strategies to optimise antibiotic use in general practice is critical to further support appropriate antibiotic use and mitigate antimicrobial resistance.

Abstract Background Six percent of patients are allergic to penicillin according to their medical records. While this designation protects a small number of truly allergic patients from serious reactions, those who are incorrectly labelled may be denied access to recommended first line treatment for many infections. Removal of incorrect penicillin allergy may have positive health consequences for the individual and the general population. We aimed to explore primary care physicians’ (PCPs) and patients’ views and understanding of penicillin allergy with a focus on clinical management of infections in the face of a penicillin allergy record. Methods We conducted an interview study with 31 patients with a penicillin allergy record, and 19 PCPs in the North of England. Data were analysed thematically. Results Patients made sense of their allergy status by considering the timing and severity of symptoms. Diagnosis of penicillin allergy was reported to be ‘imperfect’ with PCPs relying on patient reports and incomplete medical records. PCPs and patients often suspected that an allergy record was incorrect, but PCPs were reluctant to change records. PCPs had limited knowledge of allergy services. PCPs often prescribed alternative antibiotics which were easy to identify. Both patients and PCPs differed in the extent to which they were aware of the negative consequences of incorrect penicillin allergy records, their relevance and importance to their lives, and management of penicillin allergy. Conclusions PCPs and patients appear insufficiently aware of potential harms associated with incorrect penicillin allergy records. Some of the problems experienced by PCPs could be reduced by ensuring the details of newly diagnosed reactions to antibiotics are clearly documented. In order for PCPs to overturn more incorrect penicillin records through appropriate use of allergy services, more information and training about these services will be needed.

Abstract Background As COVID-19 death rates have risen and health-care systems have experienced increased demand, national testing strategies have come under scrutiny. Utilising qualitative interview data from a larger COVID-19 study, this paper provides insights into influences on and the enactment of national COVID-19 testing strategies for health care workers (HCWs) in English NHS settings during wave one of the COVID-19 pandemic (March–August 2020). Through the findings we aim to inform learning about COVID-19 testing policies and practices; and to inform future pandemic diagnostic preparedness. Methods A remote qualitative, semi-structured longitudinal interview method was employed with a purposive snowball sample of senior scientific advisors to the UK Government on COVID-19, and HCWs employed in NHS primary and secondary health care settings in England. Twenty-four interviews from 13 participants were selected from the larger project dataset using a key term search, as not all of the transcripts contained references to testing. Framework analysis was informed by the non-adoption, abandonment, scale-up, spread, and sustainability of patient-facing health and care technologies implementation framework (NASSS) and by normalisation process theory (NPT). Results Our account highlights tensions between the communication and implementation of national testing developments; scientific advisor and HCW perceptions about infectiousness; and uncertainties about the responsibility for testing and its implications at the local level. Conclusions Consideration must be given to the implications of mass NHS staff testing, including the accuracy of information communicated to HCWs; how HCWs interpret, manage, and act on testing guidance; and the influence these have on health care organisations and services.

As the COVID-19 pandemic has shown, setting up studies in time to gather relevant, real-world data enables researchers to capture current views and experiences, focus on practicalities on the ground, and deliver actionable results. Delivering high quality rapid studies in healthcare poses several challenges even in non-emergency situations. There is an expanding literature discussing benefits and challenges of conducting rapid research, yet there are relatively few examples related to methodological dilemmas and decisions that researchers may face when conducting rapid studies. In rapidly-changing emergency contexts, some of these challenges may be more easily overcome, while others may be unique to the emergency, magnified, or emerge in different ways. In this manuscript, we discuss our reflections and lessons learnt across the research process when conducting rapid qualitative interview studies in the context of a healthcare emergency, focusing on methodological issues. By this we mean the challenging considerations and pragmatic choices we made, and their downstream impacts, that shaped our studies. We draw on our extensive combined experience of delivering several projects during the COVID-19 pandemic in both single and multi-country settings, where we implemented rapid studies, or rapidly adapted an existing study. In the context of these studies, we discuss two main considerations, with a particular focus on the complexities, multiple facets, and trade-offs involved in: (i) team-based approaches to qualitative studies; and (ii) timely and rapid data collection, analysis and dissemination. We contribute a transparent discussion of these issues, describing them, what helped us to deal with them, and which issues have been difficult to overcome. We situate our discussion of arising issues in relation to existing literature, to offer broader recommendations while also identifying gaps in current understandings of how to deal with these methodological challenges. We thus identify key considerations, lessons, and possibilities for researchers implementing rapid studies in healthcare emergencies and beyond. We aim to promote transparency in reporting, assist other researchers in making informed choices, and consequently contribute to the development of the rapid qualitative research.

Background: The impact of the COVID-19 pandemic on patients’ and clinicians’ perceptions of healthcare-seeking behaviour and delivery of care is unclear. The pandemic accelerated the use of remote care, and understanding its benefits and drawbacks may inform its implementation during current and future healthcare emergencies. Aim: To explore patients’ and primary care professionals’ (PCPs) experiences of primary care delivery in the first wave of the pandemic. Design & setting: Qualitative study using semi-structured interviews in primary care in eight European countries (England, Ireland, Belgium, the Netherlands, Greece, Poland, Sweden, and Germany). Method: A total of 146 interviews were conducted with 80 PCPs and 66 patients consulting for respiratory tract infection (RTI) symptoms, in eight European countries. Data were collected between April and July 2020, and analysed using thematic analysis. Results: It was found that patients accepted telemedicine when PCPs spent time to understand and address their concerns, but a minority preferred in-person consultations. PCPs felt that remote consultations created emotional distance between themselves and patients, and they reported having to manage diverse COVID-19-related medical and social concerns. Conclusion: Remote consultations for RTI symptoms may be acceptable long term if both groups are happy to use this format, but it is important that PCPs take time to address patients’ concerns and provide safety-netting advice.

An estimated 2.7 million people in the UK are potentially prevented from accessing highly effective and inexpensive penicillins as a result of incorrect penicillin allergy records. Removing incorrect penicillin allergy records may lead to improved patient outcomes and contribute to the tackling of antibiotic resistance. We aim to develop and evaluate whether the ‘Penicillin Allergy Assessment Pathway’ (PAAP) is effective in improving patient outcomes. At the first stage of this work, we have focused on understanding patients’ and primary care clinicians’ views of attending and referring to penicillin allergy testing, and then prescribing and consuming penicillin following a negative test result.

Abstract Background Trials have shown that delayed antibiotic prescriptions (DPs) and point-of-care C-Reactive Protein testing (POC-CRPT) are effective in reducing antibiotic use in general practice, but these were not typically implemented in high-prescribing practices. We aimed to explore views of professionals from high-prescribing practices about uptake and implementation of DPs and POC-CRPT to reduce antibiotic use. Methods This was a qualitative focus group study in English general practices. The highest antibiotic prescribing practices in the West Midlands were invited to participate. Clinical and non-clinical professionals attended focus groups co-facilitated by two researchers. Focus groups were audio-recorded, transcribed verbatim and analysed thematically. Results Nine practices (50 professionals) participated. Four main themes were identified. Compatibility of strategies with clinical roles and experience – participants viewed the strategies as having limited value as ‘clinical tools’, perceiving them as useful only in ‘rare’ instances of clinical uncertainty and/or for those less experienced. Strategies as ‘social tools’ – participants perceived the strategies as helpful for negotiating treatment decisions and educating patients, particularly those expecting antibiotics. Ambiguities – participants perceived ambiguities around when they should be used, and about their impact on antibiotic use. Influence of context – various other situational and practical issues were raised with implementing the strategies. Conclusions High-prescribing practices do not view DPs and POC-CRPT as sufficiently useful ‘clinical tools’ in a way which corresponds to the current policy approach advocating their use to reduce clinical uncertainty and improve antimicrobial stewardship. Instead, policy attention should focus on how these strategies may instead be used as ‘social tools’ to reduce unnecessary antibiotic use. Attention should also focus on the many ambiguities (concerns and questions) about, and contextual barriers to, using these strategies that need addressing to support wider and more consistent implementation.

BackgroundChildren with long-term illnesses frequently experience symptoms that could negatively affect their daily lives. These symptoms are often underreported in health care. Despite a large number of mobile health (mHealth) tools, few are based on a theoretical framework or supported by scientific knowledge. Incorporating universal design when developing a product can promote accessibility and facilitate person-centered communication. ObjectiveThe aim of this study is to identify the symptom-reporting needs of children with cancer and congenital heart defects that could be satisfied by using a mobile app. Another aim is to evaluate how the child might interact with the app by considering universal design principles and to identify parents’ views and health care professionals’ expectations and requirements for an mHealth tool. MethodsUser-centered design is an iterative process that focuses on an understanding of the users. The adapted user-centered design process includes 2 phases with 4 stages. Phase 1 involved interviews with 7 children with long-term illnesses, 8 parents, and 19 health care professionals to determine their needs and wishes for support; a workshop with 19 researchers to deepen our understanding of the needs; and a workshop with developers to establish a preliminary tool to further investigate needs and behaviors. Phase 2 involved interviews with 10 children with long-term illnesses, 9 parents, and 21 health care professionals to evaluate the mock-up (prototype) of the mHealth tool. Data were synthesized using the interpretive description technique. ResultsA total of 4 aspects of needs emerged from the synthesis of the data, as follows: different perspectives on provided and perceived support; the need for an easy-to-use, non–clinic-based tool to self-report symptoms and to facilitate communication; the need for safety by being in control and reaching the child’s voice; and a way of mapping the illness journey to facilitate recall and improve diagnostics. The children with long-term illnesses expressed a need to not only communicate about pain but also communicate about anxiety, fatigue, fear, and nausea. ConclusionsThe findings of this study indicated that the PicPecc (Pictorial Support in Person-Centered Care for Children) app is a potential solution for providing communicative support to children with long-term illnesses dealing with multiple symptoms and conditions. The interview data also highlighted symptoms that are at risk of being overlooked if they are not included in the mobile app. Further studies are needed to include usability testing and evaluation in hospitals and home care settings.

Abstract Background To reduce inappropriate antibiotic use, public health campaigns often provide fear-based information about antimicrobial resistance (AMR). Meta-analyses have found that fear-based campaigns in other contexts are likely to be ineffective unless respondents feel confident they can carry out the recommended behaviour (‘self-efficacy’). This study aimed to test the likely impact of fear-based messages, with and without empowering self-efficacy elements, on patient consultations/antibiotic requests for influenza-like illnesses, using a randomised design. Methods We hypothesised that fear-based messages containing empowering information about self-management without antibiotics would be more effective than fear alone, particularly in a pre-specified subgroup with low AMR awareness. Four thousand respondents from an online panel, representative of UK adults, were randomised to receive three different messages about antibiotic use and AMR, designed to induce fear about AMR to varying degrees. Two messages (one ‘strong-fear’, one ‘mild-fear’) also contained empowering information regarding influenza-like symptoms being easily self-managed without antibiotics. The main outcome measures were self-reported effect of information on likelihood of visiting a doctor and requesting antibiotics, for influenza-like illness, analysed separately according to whether or not the AMR information was ‘very/somewhat new’ to respondents, pre-specified based on a previous (non-randomised) survey. Results The ‘fear-only’ message was ‘very/somewhat new’ to 285/1000 (28.5%) respondents, ‘mild-fear-plus-empowerment’ to 336/1500 (22.4%), and ‘strong-fear-plus-empowerment’ to 388/1500 (25.9%) (p = 0.002). Of those for whom the respective information was ‘very/somewhat new’, only those given the ‘strong-fear-plus-empowerment’ message said they would be less likely to request antibiotics if they visited a doctor for an influenza-like illness (p

The impacts of healthcare professionals (HCPs) being research participants are often neglected. As professionals, they tend to be perceived as ‘immune’ to many negative effects of sharing their experiences. However, in the context of an ongoing global pandemic such as COVID-19, these assumptions can be clearly challenged. This article draws on researchers’ experiences of conducting single and longitudinal qualitative interviews with HCPs during the COVID-19 pandemic in Europe during 2020. Reflecting on the methodological and ethical implications of doing such research during a pandemic allows researchers to surface assumptions about and question categories of ‘vulnerability’ and ‘sensitivity’. We explore these categories in relation to three issues we have identified: (i) Blurred boundaries in researcher-participant relationships; (ii) Interviews as spaces to process experiences; and (iii) Motivations to conduct and participate in research. We demonstrate that qualitative interviews during a pandemic are embedded in sense-making processes for both the interviewer and participant, and as such may play an important role in coping and resilience. We therefore argue for ethically active research that critically engages with the concepts of ‘vulnerability’ and ‘sensitivity’, and underpinning assumptions, in context over time throughout the research process for current and future research with HCPs and other groups beyond pandemic situations. We thus aim to prepare researchers for managing these potential facets during the research process. We conclude with practical implications for managing emerging ethical tensions, methodological challenges and the wide-ranging possibilities and responsibilities for research with HCPs, urging researchers to consider the issues in advance.

Implementation of TB infection prevention and control (IPC) measures in health facilities is frequently inadequate, despite nosocomial TB transmission to patients and health workers causing harm. We aimed to review qualitative evidence of the complexity associated with implementing TB IPC, to help guide the development of TB IPC implementation plans. We undertook a qualitative evidence synthesis of studies that used qualitative methods to explore the experiences of health workers implementing TB IPC in health facilities. We searched eight databases in November 2021, complemented by citation tracking. Two reviewers screened titles and abstracts and reviewed full texts of potentially eligible papers. We used the Critical Appraisals Skills Programme checklist for quality appraisal, thematic synthesis to identify key findings and the GRADE-CERQual method to appraise the certainty of review findings. The review protocol was pre-registered on PROSPERO, ID CRD42020165314. We screened 1062 titles and abstracts and reviewed 102 full texts, with 37 studies included in the synthesis. We developed 10 key findings, five of which we had high confidence in. We describe several components of TB IPC as a complex intervention. Health workers were influenced by their personal occupational TB risk perceptions when deciding whether to implement TB IPC and neglected the contribution of TB IPC to patient safety. Health workers and researchers expressed multiple uncertainties (for example the duration of infectiousness of people with TB), assumptions and misconceptions about what constitutes effective TB IPC, including focussing TB IPC on patients known with TB on treatment who pose a small risk of transmission. Instead, TB IPC resources should target high risk areas for transmission (crowded, poorly ventilated spaces). Furthermore, TB IPC implementation plans should support health workers to translate TB IPC guidelines to local contexts, including how to navigate unintended stigma caused by IPC, and using limited IPC resources effectively.

BackgroundWorking under pandemic conditions exposes health care workers (HCWs) to infection risk and psychological strain. A better understanding of HCWs' experiences of following local infection prevention and control (IPC) procedures during COVID-19 is urgently needed to inform strategies for protecting the psychical and psychological health of HCWs. The objective of this study was therefore to capture the perceptions of hospital HCWs on local IPC procedures and the impact on their emotional wellbeing during the first wave of the COVID-19 pandemic in Europe.MethodsParticipants were recruited in two sampling rounds of an international cross-sectional survey. Sampling took place between 31 March and 17 April 2020 via existing research networks and between 14 May and 31 August 2020 via online convenience sampling. Main outcome measures were behavioural determinants of HCWs' adherence to IPC guidelines and the WHO-5 Well-Being Index, a validated scale of 0-100 reflecting emotional wellbeing. The WHO-5 was interpreted as a score below or above 50 points, a cut-off score used in previous literature to screen for depression.Results2289 HCWs from 40 countries in Europe participated. Mean age was 42 (±11) years, 66% were female, 47% and 39% were medical doctors and nurses, respectively. 74% (n = 1699) of HCWs were directly treating patients with COVID-19, of which 32% (n = 527) reported they were fearful of caring for these patients. HCWs reported high levels of concern about COVID-19 infection risk to themselves (71%) and their family (82%) as a result of their job. 40% of HCWs considered that getting infected with COVID-19 was not within their control. This feeling was more common among junior than senior HCWs (46% versus 38%, P value < .01). Sufficient COVID-19-specific IPC training, confidence in PPE use and institutional trust were positively associated with the feeling that becoming infected with COVID-19 was within their control. Female HCWs were more likely than males to report a WHO-5 score below 50 points (aOR 1.5 (95% confidence interval (CI) 1.2-1.8).ConclusionsIn Europe, the COVID-19 pandemic has had a differential impact on those providing direct COVID-19 patient care, junior staff and women. Health facilities must be aware of these differential impacts, build trust and provide tailored support for this vital workforce during the current COVID-19 pandemic.

Objective To identify the experiences and concerns of health workers (HWs), and how they changed, throughout the first year of the COVID-19 pandemic in the UK. Methods Longitudinal, qualitative study with HWs involved in patient management or delivery of care related to COVID-19 in general practice, emergency departments and hospitals. Participants were identified through snowballing. Semi-structured telephone or video interviews were conducted between February 2020 and February 2021, audio-recorded, summarised, and transcribed. Data were analysed longitudinally using framework and thematic analysis. Results We conducted 105 interviews with 14 participants and identified three phases corresponding with shifts in HWs’ experiences and concerns. (1) Emergency and mobilisation phase (late winter-spring 2020), with significant rapid shifts in responsibilities, required skills, and training, and challenges in patient care. (2) Consolidation and preparation phase (summer-autumn 2020), involving gradual return to usual care and responsibilities, sense of professional development and improvement in care, and focus on learning and preparing for future. (3) Exhaustion and survival phase (autumn 2020-winter 2021), entailing return of changes in responsibilities, focus on balancing COVID-19 and non-COVID care (until becoming overwhelmed with COVID-19 cases), and concerns about longer-term impacts of unceasing pressure on health services. Participants’ perceptions of COVID-19 risk and patient/public attitudes changed throughout the year, and tiredness and weariness turned into exhaustion. Conclusions Results showed a long-term impact of the COVID-19 pandemic on UK HWs’ experiences and concerns related to changes in their roles, provision of care, and personal wellbeing. Despite mobilisation in the emergency phase, and trying to learn from this, HWs’ experiences seemed to be similar or worse in the second wave partly due to many COVID-19 cases. The findings highlight the importance of supporting HWs and strengthening system-level resilience (e.g., with resources, processes) to enable them to respond to current and future demands and emergencies.

Background: Minimising primary care professionals' (PCPs) risk of SARS-CoV-2 infection is crucial to ensure their safety as well as functioning health care system. PCPs' perspectives on the support they needed in the early stages of a public health crisis can inform future preparedness.Aim: To understand PCPs' experiences of providing care during the COVID-19 pandemic, with focus on personal risk from COVID-19 and testing.Design and Setting: Qualitative study using semi-structured interviews with PCPs in England, Belgium, the Netherlands, Ireland, Germany, Poland, Greece and Sweden, between April and July 2020.Method: Interviews were analysed using a combination of inductive and deductive thematic analysis techniques.Results: Eighty interviews were conducted, showing that PCPs tried to make sense of their risk of both contracting and severity of COVID-19 by assessing individual risk factors and perceived effectiveness of Personal Protective Equipment (PPE). They had limited access to PPE yet continued providing care as their “duty.” Some PCPs felt that they were put in high-risk situations when patients or colleagues were not flagging symptoms of COVID-19. Not having access to testing in the initial stages of the pandemic was somewhat accepted but when available, was valued.Conclusion: Access to adequate PPE and testing, as well as training for staff and education for patients about the importance of ensuring staff safety is crucial. Given PCPs' varied response in how they appraised personal risk and their tolerance for working, PCPs may benefit from the autonomy in deciding how they want to work during health emergencies.

Objectives Successful implementation of asymptomatic testing programmes using lateral flow tests (LFTs) depends on several factors, including feasibility, acceptability and how people act on test results. We aimed to examine experiences of university students and staff of regular asymptomatic self-testing using LFTs, and their subsequent behaviours.Design and setting A qualitative study using semistructured remote interviews and qualitative survey responses, which were analysed thematically.Participants People who were participating in weekly testing feasibility study, between October 2020 and January 2021, at the University of Oxford.Results We interviewed 18 and surveyed 214 participants. Participants were motivated to regularly self-test as they wanted to know whether or not they were infected with SARS-CoV-2. Most reported that a negative test result did not change their behaviour, but it did provide them with reassurance to engage with permitted activities. In contrast, some participants reported making decisions about visiting other people because they felt reassured by a negative test result. Participants valued the training but some still doubted their ability to carry out the test. Participants were concerned about safety of attending test sites with lots of people and reported home testing was most convenient.Conclusions Clear messages highlighting the benefits of regular testing for family, friends and society in identifying asymptomatic cases are needed. This should be coupled with transparent communication about the accuracy of LFTs and how to act on either a positive or negative result. Concerns about safety, convenience of testing and ability to do tests need to be addressed to ensure successful scaling up of asymptomatic testing.

Introduction In order to tackle the pandemic, governments have established various types of advisory boards to provide evidence and recommendations to policy makers. Scientists working on these boards have faced many challenges, including working under significant time constraints to produce ‘evidence’ as quickly as possible. However, their voices are still largely missing in the discussion. This study explores the views and experiences of scientists working on government advisory boards during the COVID-19 pandemic, with the aim to learn lessons for future pandemic management and preparedness.Methods We conducted online video or telephone semi-structured interviews between December 2020 and April 2021 with 21 scientists with an official government advisory role during the COVID-19 pandemic in Belgium, the Netherlands, UK, Sweden and Germany. The interviews were audio-recorded and transcribed and analysed using a combination of inductive and deductive thematic analysis techniques.Results Scientists viewed the initial focus on biomedically oriented work during the pandemic as somewhat one-dimensional, but also highlighted difficulties of working in an interdisciplinary way. They found it difficult at times to ensure that the evidence is understood and taken on board by governments. They found themselves taking on new roles, the boundaries of which were not clearly defined. Consequently, they were often perceived and treated as a public figure.Conclusion Scientists working on advisory boards in European countries faced similar challenges, highlighting key lessons to be learnt. Future pandemic preparedness efforts should focus on building interdisciplinary collaboration through development of scientists’ skills and appropriate infrastructure; ensuring transparency in how boards operate; defining and protecting the boundaries of the scientific advisor role; and supporting scientists to inform the public in the fight against disinformation, while dealing with potential hostile reactions.

BackgroundDelayed (or "backup") antibiotic prescription, where the patient is given a prescription but advised to delay initiating antibiotics, has been shown to be effective in reducing antibiotic use in primary care. However, this strategy is not widely used in the United Kingdom. This study aimed to identify factors influencing preferences among the UK public for delayed prescription, and understand their relative importance, to help increase appropriate use of this prescribing option.Methods and findingsWe conducted an online choice experiment in 2 UK general population samples: adults and parents of children under 18 years. Respondents were presented with 12 scenarios in which they, or their child, might need antibiotics for a respiratory tract infection (RTI) and asked to choose either an immediate or a delayed prescription. Scenarios were described by 7 attributes. Data were collected between November 2018 and February 2019. Respondent preferences were modelled using mixed-effects logistic regression. The survey was completed by 802 adults and 801 parents (75% of those who opened the survey). The samples reflected the UK population in age, sex, ethnicity, and country of residence. The most important determinant of respondent choice was symptom severity, especially for cough-related symptoms. In the adult sample, the probability of choosing delayed prescription was 0.53 (95% confidence interval (CI) 0.50 to 0.56, p < 0.001) for a chesty cough and runny nose compared to 0.30 (0.28 to 0.33, p < 0.001) for a chesty cough with fever, 0.47 (0.44 to 0.50, p < 0.001) for sore throat with swollen glands, and 0.37 (0.34 to 0.39, p < 0.001) for sore throat, swollen glands, and fever. Respondents were less likely to choose delayed prescription with increasing duration of illness (odds ratio (OR) 0.94 (0.92 to 0.96, p < 0.001)). Probabilities of choosing delayed prescription were similar for parents considering treatment for a child (44% of choices versus 42% for adults, p = 0.04). However, parents differed from the adult sample in showing a more marked reduction in choice of the delayed prescription with increasing duration of illness (OR 0.83 (0.80 to 0.87) versus 0.94 (0.92 to 0.96) for adults, p for heterogeneity p < 0.001) and a smaller effect of disruption of usual activities (OR 0.96 (0.95 to 0.97) versus 0.93 (0.92 to 0.94) for adults, p for heterogeneity p < 0.001). Females were more likely to choose a delayed prescription than males for minor symptoms, particularly minor cough (probability 0.62 (0.58 to 0.66, p < 0.001) for females and 0.45 (0.41 to 0.48, p < 0.001) for males). Older people, those with a good understanding of antibiotics, and those who had not used antibiotics recently showed similar patterns of preferences. Study limitations include its hypothetical nature, which may not reflect real-life behaviour; the absence of a "no prescription" option; and the possibility that study respondents may not represent the views of population groups who are typically underrepresented in online surveys.ConclusionsThis study found that delayed prescription appears to be an acceptable approach to reducing antibiotic consumption. Certain groups appear to be more amenable to delayed prescription, suggesting particular opportunities for increased use of this strategy. Prescribing choices for sore throat may need additional explanation to ensure patient acceptance, and parents in particular may benefit from reassurance about the usual duration of these illnesses.

Objective To describe primary health care (consultation characteristics and management) for patients contacting their general practitioner (GP) with a respiratory tract infection (RTI) early on in the COVID-19 pandemic in contrasting European countries, with comparison to prepandemic findings.Setting Primary care in 16 countries (79 practices), when no routine SARS-CoV-2 testing was generally available.Design and participants Before (n=4376) and early in the pandemic (n=3301), patients with RTI symptoms were registered in this prospective audit study.Outcome measures Consultation characteristics (type of contact and use of PPE) and management characteristics (clinical assessments, diagnostic testing, prescribing, advice and referral) were registered. Differences in these characteristics between countries and between pandemic and prepandemic care are described.Results Care for patients with RTIs rapidly switched to telephone/video consultations (10% in Armenia, 91% in Denmark), and when consultations were face-to-face, GPs used PPE during 97% (95% CI 96% to 98%) of contacts. Laboratory testing for SARS-CoV-2 in primary care patients with RTIs was rapidly implemented in Denmark (59%) and Germany (31%), while overall testing for C reactive protein decreased. The proportion of patients prescribed antibiotics varied considerably between countries (3% in Belgium, 48% in UK) and was lower during the pandemic compared with the months before, except for Greece, Poland and UK. GPs provided frequent and varied COVID-related advice and more frequently scheduled a follow-up contact (50%, 95% CI 48% to 52%). GPs reported a slightly higher degree of confidence in the likely effectiveness of their management in face-to-face (73% (very) confident, 95% CI 71% to 76%) than in virtual consultations (69%, 95% CI 67% to 71%).Conclusions Despite between-country variation in consultation characteristics, access to SARS-CoV-2 laboratory testing and medication prescribing, GPs reported a high degree of confidence in managing their patients with RTIs in the emerging pandemic. Insight in the highly variable pandemic responses, as measured in this multicountry audit, can aid in fine-tuning national action and in coordinating a pan-European response during future pandemic threats.

Introduction There is an urgent need to idenfy treatments for COVID-19 that reduce illness duration and hospital admission in those at higher risk of a longer illness course and complications.Methods and analysis The Platform Randomised trial of INterventions against COVID-19 In older peoPLE trial is an open-label, multiarm, prospective, adaptive platform, randomised clinical trial to evaluate potential treatments for COVID-19 in the community. A master protocol governs the addition of new interventions as they become available, as well as the inclusion and cessation of existing intervention arms via frequent interim analyses. The first three interventions are hydroxychloroquine, azithromycin and doxycycline. Eligible participants must be symptomatic in the community with possible or confirmed COVID-19 that started in the preceding 14 days and either (1) aged 65 years and over or (2) aged 50–64 years with comorbidities. Recruitment is through general practice, health service helplines, COVID-19 ‘hot hubs’ and directly through the trial website. Participants are randomised to receive either usual care or a study drug plus usual care, and outcomes are collected via daily online symptom diary for 28 days from randomisation. The research team contacts participants and/or their study partner following days 7, 14 and 28 if the online diary is not completed. The trial has two coprimary endpoints: time to first self-report of feeling recovered from possible COVID-19 and hospital admission or death from possible COVID-19 infection, both within 28 days from randomisation. Prespecified interim analyses assess efficacy or futility of interventions and to modify randomisation probabilities that allocate more participants to interventions with better outcomes.Ethics and dissemination Ethical approval Ref: 20/SC/0158 South Central - Berkshire Research Ethics Committee; IRAS Project ID: 281958; EudraCT Number: 2020-001209-22. Results will be presented to policymakers and at conferences and published in peer-reviewed journals.Trial registration number ISRCTN86534580.

Introduction Access to HIV viral load testing remains difficult for many people on antiretroviral therapy (ART) in low-income and middle-income countries. Weak laboratory and clinic systems often delay the detection and management of viraemia, which can lead to morbidity, drug resistance and HIV transmission. Point-of-care testing could overcome these challenges. We aim to assess whether it is feasible to conduct a randomised trial of point-of-care viral load testing to manage viraemia.Methods and analysis We will conduct an open-label, single-site, individually randomised, feasibility study of Point-Of-care HIV viral load testing to Enhance Re-suppression, in Durban, South Africa. We will enrol approximately 100 people living with HIV who are aged ≥18 years, receiving first-line ART but with recent viraemia ≥1000 copies/mL, and randomise them 1:1 to receive point-of-care viral load or standard laboratory viral load monitoring, after 12 weeks. All participants will continue to receive care from public sector healthcare workers following South African HIV management guidelines. Participants with persistent viraemia ≥1000 copies/mL will be considered for switching to second-line ART. We will compare the proportion in each study arm who achieve the primary outcome of viral suppression

BackgroundHouseholds are important sites for transmission of SARS-CoV-2 and preventive measures are recommended. This study aimed to 1) investigate the impact of living with a person infected with SARS-CoV-2; 2) understand how household members implemented infection control recommendations in their home; and 3) identify the information and support needs of household members.MethodsFor this observational mixed-methods study, households with a person with confirmed SARS-CoV-2 infection were recruited via drive-through testing sites of Municipal Health Services, healthcare worker screening or hospital emergency visits in the University Medical Centre Utrecht, the Netherlands and via primary care physicians, hospital emergency visits or preoperative screening in the University Hospital of Antwerp, Belgium. We recorded household characteristics, including characteristics of all household members, together with their views on prevention measures. In a subset of households one adult household member was asked to participate in an interview investigating their views on preventive measures. Survey data were analysed using descriptive statistics and interview data by rapid framework analysis. A triangulation protocol was used to integrate findings.ResultsThirty-four households (120 household members) were included in the quantitative survey. Twenty-two households were invited to be interviewed, of which 18 completed an interview (response 81.8%). Survey data showed that almost all households implemented some preventive measures, the use of face masks being least frequently reported. Measures taken depended on what was physically possible, the perceived severity of illness of the index patient and to what extent household members were willing to limit social interaction. Respondents did not believe in the effectiveness of wearing face masks within the house, and from the interviews this was explained by media coverage of face masks, impracticality and the stigma associated with wearing masks. Interviewees reported that quarantine had a high emotional burden and wished to have more information about the exact duration of quarantine, their own COVID-19 status, symptoms and when to seek medical help.ConclusionPeople were willing to implement prevention measures, however actual adherence depended on perceived severity of illness and the perceived risk of becoming infected. Homes are social environments and recommendations for infection prevention should account for this context. Incorporating our findings into policy making could provide households with more relevant and actionable advice.

Objective While various interventions have helped reduce antibiotic prescribing, further gains can be made. This study aimed to identify ways to optimise antimicrobial stewardship (AMS) interventions by assessing the extent to which important influences on antibiotic prescribing are addressed (or not) by behavioural content of AMS interventions.Settings English primary care.Interventions AMS interventions targeting healthcare professionals’ antibiotic prescribing for respiratory tract infections.Methods We conducted two rapid reviews. The first included qualitative studies with healthcare professionals on self-reported influences on antibiotic prescribing. The influences were inductively coded and categorised using the Theoretical Domains Framework (TDF). Prespecified criteria were used to identify key TDF domains. The second review included studies of AMS interventions. Data on effectiveness were extracted. Components of effective interventions were extracted and coded using the TDF, Behaviour Change Wheel and Behaviour Change Techniques (BCTs) taxonomy. Using prespecified matrices, we assessed the extent to which BCTs and intervention functions addressed the key TDF domains of influences on prescribing.Results We identified 13 qualitative studies, 41 types of influences on antibiotic prescribing and 6 key TDF domains of influences: ‘beliefs about consequences’, ‘social influences’, ‘skills’, ‘environmental context and resources’, ‘intentions’ and ‘emotions’. We identified 17 research-tested AMS interventions; nine of them effective and four nationally implemented. Interventions addressed all six key TDF domains of influences. Four of these six key TDF domains were addressed by 50%–67% BCTs that were theoretically congruent with these domains, whereas TDF domain 'skills' was addressed by 24% of congruent BCTs and 'emotions' by none.Conclusions Further improvement of antibiotic prescribing could be facilitated by: (1) national implementation of effective research-tested AMS interventions (eg, electronic decision support tools, training in interactive use of leaflets, point-of-care testing); (2) targeting important, less-addressed TDF domains (eg, 'skills', 'emotions'); (3) using relevant, under-used BCTs to target key TDF domains (eg, ‘forming/reversing habits’, ‘reducing negative emotions’, ‘social support’). These could be incorporated into existing, or developed as new, AMS interventions.

Objectives To develop a behavioural intervention package to support clinicians and patients to amend incorrect penicillin allergy records in general practice. The intervention aimed to: (1) support clinicians to refer patients for penicillin allergy testing (PAT), (2) support patients to attend for PAT and (3) support clinicians and patients to prescribe or consume penicillin, when indicated, following a negative PAT result.Methods Theory-based, evidence-based and person-based approaches were used in the intervention development. We used evidence from a rapid review, two qualitative studies, and expert consultations with the clinical research team to identify the intervention ‘guiding principles’ and develop an intervention plan. Barriers and facilitators to the target behaviours were mapped to behaviour change theory in order to describe the proposed mechanisms of change. In the final stage, think-aloud interviews were conducted to optimise intervention materials.Results The collated evidence showed that the key barriers to referral of patients by clinicians were limited experience of referral and limited knowledge of referral criteria and PAT. Barriers for patients attending PAT were lack of knowledge of the benefits of testing and lack of motivation to get tested. The key barriers to the prescription and consumption of first-line penicillin following a negative test result were patient and clinician beliefs about the accuracy of PAT and whether taking penicillin was safe. Intervention materials were designed and developed to address these barriers.Conclusions We present a novel behavioural intervention package designed to address the multiple barriers to uptake of PAT in general practice by clinicians and patients. The intervention development details how behaviour change techniques have been incorporated to hypothesise how the intervention is likely to work to help amend incorrect penicillin allergy records. The intervention will go on to be tested in a feasibility trial and randomised controlled trial in England.

Background: In 2017, approximately 73% of antibiotics in England were prescribed from primary care practices. It has been estimated that 9%–23% of antibiotic prescriptions between 2013 and 2015 were inappropriate. Reducing antibiotic prescribing in primary care was included as one of the national priorities in a financial incentive scheme in 2015–2016. Aim: To investigate whether the effects of the Quality Premium (QP), which provided performance-related financial incentives to clinical commissioning groups (CCGs), could be explained by practice characteristics that contribute to variations in antibiotic prescribing. Design & setting: Longitudinal monthly prescribing data were analysed for 6251 primary care practices in England from April 2014 to March 2016. Method: Linear generalised estimating equations models were fitted, examining the effect of the 2015–2016 QP on the number of antibiotic items per specific therapeutic group age–sex related prescribing unit (STAR-PU) prescribed, adjusting for seasonality and months since implementation. Consistency of effects after further adjustment for variations in practice characteristics were also examined, including practice workforce, comorbidities prevalence, prescribing rates of non-antibiotic drugs, and deprivation. Results: Antibiotics prescribed in primary care practices in England reduced by -0.172 items per STAR-PU (95% confidence interval [CI] = -0.180 to -0.171) after 2015–2016 QP implementation, with slight increases in the months following April 2015 (+0.014 items per STAR-PU; 95% CI = +0.013 to +0.014). Adjusting the model for practice characteristics, the immediate and month-on-month effects following implementation remained consistent, with slight attenuation in immediate reduction from -0.172 to -0.166 items per STAR-PU. In subgroup analysis, the QP effect was significantly greater among the top 20% prescribing practices (interaction p

Introduction Providing antiretroviral therapy (ART) for millions of people living with HIV requires efficient, client-centred models of differentiated ART delivery. In South Africa, the Centralised Chronic Medication Dispensing and Distribution (CCMDD) programme allows over 1 million people to collect chronic medication, including ART, from community pick-up points. We aimed to explore how CCMDD influences engagement in HIV care.Methods We performed in-depth interviews and focus group discussions with clients receiving ART and healthcare workers in Durban, South Africa. We analysed transcripts using deductive thematic analysis, with a framework informed by ‘theories of practice’, which highlights the materialities, competencies, meanings and other life practices that underpin clients’ engagement in HIV care.Results Between March 2018 to August 2018 we undertook 25 interviews and four focus groups with a total of 55 clients, and interviewed eight healthcare workers. The material challenges of standard clinic-based ART provision included long waiting times, poor confidentiality and restricted opening hours, which discouraged clients from engagement. In contrast, CCMDD allowed quicker and more convenient ART collection in the community. This required the development of new competencies around accessing care, and helped change the meanings associated with HIV, by normalising treatment collection. CCMDD was seen as a reward by clients for taking ART well, and helped reduce disruption to other life practices such as employment. At private pharmacies, some clients reported receiving inferior care compared with paying customers, and some worried about inadvertently revealing their HIV status. Clients and healthcare workers had to negotiate problems with CCMDD implementation, including some pharmacies reaching capacity or only allowing ART collection at restricted times.Conclusions In South Africa, CCMDD overcame material barriers to attending clinics, changed the meanings associated with collecting ART and was less disruptive to other social practices in clients’ lives. Expansion of community-based ART delivery programmes may help to facilitate engagement in HIV care.Trial registration number STREAM study clinical trial registration: NCT03066128, registered February 2017.

The COVID-19 pandemic has had a profound impact on the delivery of primary care services. We aimed to identify general practitioners’ (GPs’) perceptions and experiences of how the COVID-19 pandemic influenced antibiotic prescribing and antimicrobial stewardship (AMS) in general practice in England. Twenty-four semi-structured interviews were conducted with 18 GPs at two time-points: autumn 2020 (14 interviews) and spring 2021 (10 interviews). Interviews were audio-recorded, transcribed and analysed thematically, taking a longitudinal approach. Participants reported a lower threshold for antibiotic prescribing (and fewer consultations) for respiratory infections and COVID-19 symptoms early in the pandemic, then returning to more usual (pre-pandemic) prescribing. They perceived the pandemic as having had less impact on antibiotic prescribing for urinary and skin infections. Participants perceived the changing ways of working and consulting (e.g., proportions of remote and in-person consultations) in addition to changing patient presentations and GP workloads as influencing the fluctuations in antibiotic prescribing. This was compounded by decreased engagement with, and priority of, AMS due to COVID-19-related urgent priorities. Re-engagement with AMS is needed, e.g., through reviving antibiotic prescribing feedback and targets/incentives. The pandemic disrupted, and required adaptations in, the usual ways of working and AMS. It is now important to identify opportunities, e.g., for re-organising ways of managing infections and AMS in the future.

Duchenne muscular dystrophy (DMD) is a severe progressive muscle disease that is frequently associated with secondary osteoporosis. Previous studies have shown that TGFbeta inactivating antibody improves the muscle phenotype in mdx mice, a model of DMD. In the present study, we assessed the skeletal effects of treatment with a bone-targeted TGFbeta antibody (PCT-011) in mdx mice. Micro-computed tomography showed that 8 weeks of intraperitoneal administration of PCT-011 (10 mg per kg body mass, 3 times per week) was associated with more than twofold higher trabecular bone volume at the distal femur, which was explained by a higher trabecular number. At the femoral midshaft, PCT-011 exposure increased cortical thickness but did not significantly affect the results of three-point bending tests. Histomorphometric analyses of the lumbar vertebra 4 showed that PCT-011 treatment led to a lower bone formation rate. In conclusion, treatment with the TGFbeta antibody PCT-011 had a positive effect on bone development in mdx mice. Inhibiting TGFbeta activity thus appears to be a promising approach to treat bone fragility in the context of DMD.

It is common to undertake qualitative research alongside randomised controlled trials (RCTs) when evaluating complex interventions. Researchers tend to analyse these datasets one by one and then consider their findings separately within the discussion section of the final report, rarely integrating quantitative and qualitative data or findings, and missing opportunities to combine data in order to add rigour, enabling thorough and more complete analysis, provide credibility to results, and generate further important insights about the intervention under evaluation. This paper reports on a 2 day expert meeting funded by the United Kingdom Medical Research Council Hubs for Trials Methodology Research with the aims to identify current strengths and weaknesses in the integration of quantitative and qualitative methods in clinical trials, establish the next steps required to provide the trials community with guidance on the integration of mixed methods in RCTs and set-up a network of individuals, groups and organisations willing to collaborate on related methodological activity. We summarise integration techniques and go beyond previous publications by highlighting the potential value of integration using three examples that are specific to RCTs. We suggest that applying mixed methods integration techniques to data or findings from studies involving both RCTs and qualitative research can yield insights that might be useful for understanding variation in outcomes, the mechanism by which interventions have an impact, and identifying ways of tailoring therapy to patient preference and type. Given a general lack of examples and knowledge of these techniques, researchers and funders will need future guidance on how to undertake and appraise them.

Introduction The persistent development and spread of resistance to antibiotics remain an important public health concern in the UK and globally. About 74% of antibiotics prescribed in England in 2016 was in primary care. The Quality Premium (QP) initiative that rewards Clinical Commissioning Groups (CCGs) financially based on the quality of specific health services commissioned is one of the National Health Service (NHS) England interventions to reduce antimicrobial resistance through reduced prescribing. Emerging evidence suggests a reduction in antibiotic prescribing in primary care practices in the UK following QP initiative. This study aims to investigate the mechanism of impact of this high-cost health-system level intervention on antibiotic prescribing in primary care practices in England.Methods and analysis The study will constitute secondary analyses of antibiotic prescribing data for almost all primary care practices in England from the NHS England Antibiotic Quality Premium Monitoring Dashboard and OpenPrescribing covering the period 2013 to 2018. The primary outcome is the number of antibiotic items per Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) prescribed monthly in each practice or CCG. We will first conduct an interrupted time series using ordinary least square regression method to examine whether antibiotic prescribing rate in England has changed over time, and how such changes, if any, are associated with QP implementation. Single and sequential multiple-mediator models using a unified approach for the natural direct and indirect effects will be conducted to investigate the relationship between QP initiative, the potential mediators and antibiotic prescribing rate with adjustment for practice and CCG characteristics.Ethics and dissemination This study will use secondary data that are anonymised and obtained from studies that have either undergone ethical review or generated data from routine collection systems. Multiple channels will be used in disseminating the findings from this study to academic and non-academic audiences.

Antibiotic prescribing in England varies considerably between Clinical Commissioning Groups (CCGs) and general practices. We aimed to assess social and contextual factors affecting antibiotic prescribing and engagement with antimicrobial stewardship (AMS) initiatives. Semi-structured telephone interviews were conducted with 22 CCG professionals and 19 general practice professionals. Interviews were audio-recorded, transcribed, and analyzed thematically. Social/contextual influences were grouped into the following four categories: (1) Immediate context, i.e., patients’ social characteristics (e.g., deprivation and culture), clinical factors, and practice and clinician characteristics (e.g., “struggling” with staff shortage/turnover) were linked to higher prescribing. (2) Wider context, i.e., pressures on the healthcare system, limited resources, and competing priorities were seen to reduce engagement with AMS. (3) Collaborative and whole system approaches, i.e., communication, multidisciplinary networks, leadership, and teamwork facilitated prioritizing AMS, learning, and consistency. (4) Relativity of appropriate prescribing, i.e., “high” or “appropriate” prescribing was perceived as relative, depending on comparators, and disregarding different contexts, but social norms around antibiotic use among professionals and patients seemed to be changing. Further optimization of antibiotic prescribing would benefit from addressing social/contextual factors and addressing wider health inequalities, not only targeting individual clinicians. Tailoring and adapting to local contexts and constraints, ensuring adequate time and resources for AMS, and collaborative, whole system approaches to promote consistency may help promote AMS.

Influenza-like illnesses (ILI) account for a significant portion of inappropriate antibiotic use. Patient expectations for antibiotics for ILI are likely to play a substantial role in ‘unnecessary’ antibiotic consumption. This study aimed to investigate trends in awareness of appropriate antibiotic use and antimicrobial resistance (AMR). Three sequential online surveys of independent representative samples of adults in the United Kingdom investigated expectations for, and consumption of, antibiotics for ILI (May/June 2015 (n = 2064); Oct/Nov 2016 (n = 4000); Mar 2017 (n = 4000)). Respondents were asked whether they thought antibiotics were effective for ILI and about their antibiotic use. Proportions and 95% confidence intervals (CI) were calculated for each question and interactions with respondent characteristics were tested using logistic regression. Over the three surveys, the proportion of respondents who believed antibiotics would “definitely/probably” help an ILI fell from 37% (95% CI 35–39%) to 28% (95% CI 26–29%). Those who would “definitely/probably” visit a doctor in this situation fell from 48% (95% CI 46–50%) to 36% (95% CI 34–37%), while those who would request antibiotics during a consultation fell from 39% (95% CI 37–41%) to 30% (95% CI 29–32%). The percentage of respondents who found the information we provided about AMR “new/surprising” fell from 34% (95% CI 32–36%) to 28% (95% CI 26–31%). Awareness improved more among black, Asian and minority ethnic (BAME) than white people, with little other evidence of differences in improvements between subgroups. Whilst a degree of selection bias is unavoidable in online survey samples, the results suggest that awareness of AMR and appropriate antibiotic use has recently significantly improved in the United Kingdom, according to a wide range of indicators.

Delayed antibiotic prescription in primary care has been shown to reduce antibiotic consumption, without increasing risk of complications, yet is not widely used in the UK. We sought to quantify the relative importance of factors affecting the decision to give a delayed prescription, using a stated-choice survey among UK general practitioners. Respondents were asked whether they would provide a delayed or immediate prescription in fifteen hypothetical consultations, described by eight attributes. They were also asked if they would prefer not to prescribe antibiotics. The most important determinants of choice between immediate and delayed prescription were symptoms, duration of illness, and the presence of multiple comorbidities. Respondents were more likely to choose a delayed prescription if the patient preferred not to have antibiotics, but consultation length had little effect. When given the option, respondents chose not to prescribe antibiotics in 51% of cases, with delayed prescription chosen in 21%. Clinical features remained important. Patient preference did not affect the decision to give no antibiotics. We suggest that broader dissemination of the clinical evidence supporting use of delayed prescription for specific presentations may help increase appropriate use. Establishing patient preferences regarding antibiotics may help to overcome concerns about patient acceptance. Increasing consultation length appears unlikely to affect the use of delayed prescription.