Search results
Found 19528 matches for
©
Creative Commons
The Impact of Point-of-Care Testing for Influenza on Antimicrobial Stewardship (PIAMS) in UK Primary Care: Protocol for a Mixed Methods Study
Background: Molecular point-of-care testing (POCT) used in primary care can inform whether a patient presenting with an acute respiratory infection has influenza. A confirmed clinical diagnosis, particularly early in the disease, could inform better antimicrobial stewardship. Social distancing and lockdowns during the COVID-19 pandemic have disturbed previous patterns of influenza infections in 2021. However, data from samples taken in the last quarter of 2022 suggest that influenza represents 36% of sentinel network positive virology, compared with 24% for respiratory syncytial virus. Problems with integration into the clinical workflow is a known barrier to incorporating technology into routine care. Objective: This study aims to report the impact of POCT for influenza on antimicrobial prescribing in primary care. We will additionally describe severe outcomes of infection (hospitalization and mortality) and how POCT is integrated into primary care workflows. Methods: The impact of POCT for influenza on antimicrobial stewardship (PIAMS) in UK primary care is an observational study being conducted between December 2022 and May 2023 and involving 10 practices that contribute data to the English sentinel network. Up to 1000 people who present to participating practices with respiratory symptoms will be swabbed and tested with a rapid molecular POCT analyzer in the practice. Antimicrobial prescribing and other study outcomes will be collected by linking information from the POCT analyzer with data from the patient’s computerized medical record. We will collect data on how POCT is incorporated into practice using data flow diagrams, unified modeling language use case diagrams, and Business Process Modeling Notation. Results: We will present the crude and adjusted odds of antimicrobial prescribing (all antibiotics and antivirals) given a POCT diagnosis of influenza, stratifying by whether individuals have a respiratory or other relevant diagnosis (eg, bronchiectasis). We will also present the rates of hospital referrals and deaths related to influenza infection in PIAMS study practices compared with a set of matched practices in the sentinel network and the rest of the network. We will describe any difference in implementation models in terms of staff involved and workflow. Conclusions: This study will generate data on the impact of POCT testing for influenza in primary care as well as help to inform about the feasibility of incorporating POCT into primary care workflows. It will inform the design of future larger studies about the effectiveness and cost-effectiveness of POCT to improve antimicrobial stewardship and any impact on severe outcomes.
COVID-19 vaccine effectiveness against hospitalisation and death of people in clinical risk groups during the Delta variant period: English primary care network cohort study
Background: COVID-19 vaccines have been shown to be highly effective against hospitalisation and death following COVID-19 infection. COVID-19 vaccine effectiveness estimates against severe endpoints among individuals with clinical conditions that place them at increased risk of critical disease are limited. Methods: We used English primary care medical record data from the Oxford-Royal College of General Practitioners Research and Surveillance Centre sentinel network (N > 18 million). Data were linked to the National Immunisation Management Service database, Second Generation Surveillance System for virology test data, Hospital Episode Statistics, and death registry data. We estimated adjusted vaccine effectiveness (aVE) against COVID-19 infection followed by hospitalisation and death among individuals in specific clinical risk groups using a cohort design during the delta-dominant period. We also report mortality statistics and results from our antibody surveillance in this population. Findings: aVE against severe endpoints was high, 14–69d following a third dose aVE was 96.4% (95.1%–97.4%) and 97.9% (97.2%–98.4%) for clinically vulnerable people given a Vaxzevria and Comirnaty primary course respectively. Lower aVE was observed in the immunosuppressed group: 88.6% (79.1%–93.8%) and 91.9% (85.9%–95.4%) for Vaxzevria and Comirnaty respectively. Antibody levels were significantly lower among the immunosuppressed group than those not in this risk group across all vaccination types and doses. The standardised case fatality rate within 28 days of a positive test was 3.9/1000 in people not in risk groups, compared to 12.8/1000 in clinical risk groups. Waning aVE with time since 2nd dose was also demonstrated, for example, Comirnaty aVE against hospitalisation reduced from 96.0% (95.1–96.7%) 14–69days post-dose 2–82.9% (81.4–84.2%) 182days+ post-dose 2. Interpretation: In all clinical risk groups high levels of vaccine effectiveness against severe endpoints were seen. Reduced vaccine effectiveness was noted among the immunosuppressed group.
Postpandemic Sentinel Surveillance of Respiratory Diseases in the Context of the World Health Organization Mosaic Framework: Protocol for a Development and Evaluation Study Involving the English Primary Care Network 2023-2024
Background: Prepandemic sentinel surveillance focused on improved management of winter pressures, with influenza-like illness (ILI) being the key clinical indicator. The World Health Organization (WHO) global standards for influenza surveillance include monitoring acute respiratory infection (ARI) and ILI. The WHO’s mosaic framework recommends that the surveillance strategies of countries include the virological monitoring of respiratory viruses with pandemic potential such as influenza. The Oxford-Royal College of General Practitioner Research and Surveillance Centre (RSC) in collaboration with the UK Health Security Agency (UKHSA) has provided sentinel surveillance since 1967, including virology since 1993. Objective: We aim to describe the RSC’s plans for sentinel surveillance in the 2023-2024 season and evaluate these plans against the WHO mosaic framework. Methods: Our approach, which includes patient and public involvement, contributes to surveillance objectives across all 3 domains of the mosaic framework. We will generate an ARI phenotype to enable reporting of this indicator in addition to ILI. These data will support UKHSA’s sentinel surveillance, including vaccine effectiveness and burden of disease studies. The panel of virology tests analyzed in UKHSA’s reference laboratory will remain unchanged, with additional plans for point-of-care testing, pneumococcus testing, and asymptomatic screening. Our sampling framework for serological surveillance will provide greater representativeness and more samples from younger people. We will create a biomedical resource that enables linkage between clinical data held in the RSC and virology data, including sequencing data, held by the UKHSA. We describe the governance framework for the RSC. Results: We are co-designing our communication about data sharing and sampling, contextualized by the mosaic framework, with national and general practice patient and public involvement groups. We present our ARI digital phenotype and the key data RSC network members are requested to include in computerized medical records. We will share data with the UKHSA to report vaccine effectiveness for COVID-19 and influenza, assess the disease burden of respiratory syncytial virus, and perform syndromic surveillance. Virological surveillance will include COVID-19, influenza, respiratory syncytial virus, and other common respiratory viruses. We plan to pilot point-of-care testing for group A streptococcus, urine tests for pneumococcus, and asymptomatic testing. We will integrate test requests and results with the laboratory-computerized medical record system. A biomedical resource will enable research linking clinical data to virology data. The legal basis for the RSC’s pseudonymized data extract is The Health Service (Control of Patient Information) Regulations 2002, and all nonsurveillance uses require research ethics approval. Conclusions: The RSC extended its surveillance activities to meet more but not all of the mosaic framework’s objectives. We have introduced an ARI indicator. We seek to expand our surveillance scope and could do more around transmissibility and the benefits and risks of nonvaccine therapies.
Methodological report of a cross-sectional survey of abortion-related knowledge, attitudes and practices amongst health professionals in Britain, strategies adopted and lessons learned: evidence from the SACHA Study
Background: Most surveys examining health professionals’ knowledge, attitudes and practices around abortion have used convenience samples and have targeted doctors. Our goal in the SACHA Study, drawing on evidence-based strategies to maximise response rates, was to achieve a representative sample of a wider range of health professionals, working in general practice, maternity services, pharmacies, sexual and reproductive health (SRH) clinics and specialist abortion services in Britain, to explore the knowledge, attitudes and experience of abortion care and views on future models of delivery. Methods: A cross-sectional questionnaire-based survey of midwives, doctors, nurses and pharmacists in England, Scotland and Wales was undertaken between November, 2021 and July, 2022. We used a stratified cluster sampling approach to select a random sample of sites and all eligible staff within those services were asked to respond to the survey. Evidence-based strategies to maximise completion rates were adopted, including postal delivery of the one-page questionnaire with personal letter of invitation and a stamped address envelope for return, inclusion of an unconditional voucher and follow-up. Results: Overall, 147 of the 314 (46.8%) health service sites randomly selected took part in the survey. Reasons for non-participation included local Research and Development (R&D) Department non-response, lack of resources or insufficient time to support or approve the study, lack of interest in or perceived relevance of the topic and insufficient capacity to take part, exacerbated by work demands during the COVID epidemic. Of the 1370 questionnaires sent to eligible identified participants within these services, 771 were completed and returned (56.3%). At the service level the highest proportion of returns was from SRH clinics (81.0%) and the lowest from general practice (32.4%). In relation to profession, returns were highest amongst midwives (69.6%) and lowest amongst pharmacists (36.5%). Conclusions: Obtaining information about health professional knowledge, attitudes and practices is key to guide service development and policy and to identify gaps in training and service provision in abortion. Despite our attempts to gain a representative sample of health professionals, the challenges we experienced limited the representativeness of the sample, despite the use of an evidence-based strategy.
The Pandemic EVIDENCE Collaboration Pillar 1: Diagnostics and Transmission
The COVID-19 pandemic starkly revealed a lack of high-quality evidence for non-pharmacological interventions (NPIs). The evidence produced to support the optimal deployment of NPIs in an effort to reduce transmission of SARS-CoV-2 was often of poor quality, and decisions were made without considering the wealth of previous research on respiratory virus transmission from human challenge studies. Respiratory virus infections cause illnesses varying from the “common cold” to invasive pneumonitis with multisystem involvement with severity dependent on the host-virus-immune response interaction. Despite the learnings from the recent pandemic, significant gaps remain in our understanding of the diagnosis of acute respiratory viral infections and their sequelae, the modes of transmission, and how to effectively synthesise the existing evidence from the past 70 years of research on respiratory viruses. It is crucial to examine further the evidence on how common respiratory viral agents are transmitted. The transmission dynamics to allow for a replication-competent virus to move from a reservoir to a susceptible host and establish an invasive infection is complex and it is likely multiple modes of transmission exist from direct reservoir-to-host (contact, droplet deposition, transplacental) and indirect reservoir-to-intermediary-to- host (vehicle-borne, foodborne, waterborne, and airborne) routes. To enhance our understanding of both diagnostics and transmission, we need to characterise viral entry and attachment, viral load dynamics, duration of virus infectivity both inside and outside the host, duration of viral nucleic acid shedding using molecular testing, the role of whole genome sequencing, and factors that may affect the duration of infectivity and transmission. There are still uncertainties surrounding current testing strategies and their connection to NPIs, as well as fundamental issues such as the accuracy of symptom reporting during acute respiratory infections. The importance of animal-to-animal, human-to-animal and human-to-human challenge studies in expanding our knowledge of the transmission of respiratory viruses cannot be overstated.
Experiences of integrating social prescribing link workers into primary care in England — bolting on, fitting in, or belonging: a realist evaluation
Background Following the 2019 NHS Long Term Plan, link workers have been employed across primary care in England to deliver social prescribing. Aim To understand and explain how the link worker role is being implemented in primary care in England. Design and setting This was a realist evaluation undertaken in England, focusing on link workers based in primary care. Method The study used focused ethnographies around seven link workers from different parts of England. As part of this, we interviewed 61 patients and 93 professionals from health care and the voluntary, community, and social enterprise sector. We reinterviewed 41 patients, seven link workers, and a link worker manager 9–12 months after their first interview. Results We developed four concepts from the codes developed during the project on the topic around how link workers are integrated (or not) within primary care: (or not) within primary care: centralising or diffusing power; forging an identity in general practice; demonstrating effect; and building a facilitative infrastructure. These concepts informed the development of a programme theory around a continuum of integration of link workers into primary care — from being ‘bolted on’ to existing provision, without much consideration, to ‘fitting in’, shaping what is delivered to be accommodating, through to ‘belonging’, whereby they are accepted as a legitimate source of support, making a valued contribution to patients’ broader wellbeing. Conclusion Social prescribing was introduced into primary care to promote greater attention to the full range of factors affecting patients’ health and wellbeing, beyond biomedicine. For that to happen, our analysis highlights the need for a whole-system approach to defining, delivering, and maintaining this new part of practice.
LifeAPP: self-monitoring of blood pressure after preterm preeclampsia: a randomized controlled feasibility trial.
OBJECTIVE: This was a pilot study to investigate the feasibility of developing a low-cost mobile technology-based intervention to encourage blood pressure (BP) monitoring and adoption of healthy lifestyle habits. METHODS: This was a prospective, controlled, randomized, non-blinding feasibility study that involved the use of electronic BP monitor and smartphone. Eligible participants in the intervention group were instructed to send the BP measurements to members of the LifeAPP team digitally from an application for smartphones linked to the BP device by Bluetooth and also via WhatsApp. The LifeAPP team sent feedback containing information as follows: a) safety of the BP levels; b) motivational messages aiming at maintaining self-monitoring; c) motivational messages aiming at the importance of developing healthy lifestyle habits. The primary outcome was feasibility: recruitment capacity, retention, and compliance with follow-up rates. RESULTS: Between 1 June 2020 and 24 January 2021, 48 participants were randomized to the intervention group, and 48 participants were randomized to the control group. The recruitment capacity of the participating centers proved to be adequate. Among the participants recruited for intervention group, 21 (43.7%) attended predefined visits at 3 months and only 12 (25%) attended predefined visits at 6 months. Similar loss to follow-up was observed in the control group. CONCLUSION: Despite successful recruitment of a cohort of women following preterm preeclampsia, there was no sufficient retention of participants. Therefore, new strategies for long-term follow-up of women who developed preeclampsia are needed before a further study in this group of patients can be contemplated.
Cancer inequalities in the United Kingdom and the data used to measure them: a scoping review
Significant cancer inequalities may exist across the United Kingdom (UK). Data are required to delineate and quantify these inequalities. This scoping review was undertaken to map the research evidence on UK cancer inequalities and determine the current data available, and the data gaps, that, if filled, could inform a strategy to reduce them. 444 studies were included. Their distribution across inequality domains, care pathways and cancer sites was uneven. The majority of studies were based on administrative datasets, notably cancer registry data, with a wide-range of methods used to define inequality groups. No UK-wide population-based evidence was identified. The landscape of data available in the UK to study cancer inequalities is uneven. Although there is a large volume of evidence available, there remain major gaps in both the data available and the knowledge base they are deployed to generate. This deficit needs to be addressed as a matter of urgency.
Patient safety in remote primary care encounters: Multimethod qualitative study combining Safety i and Safety II analysis
Background Triage and clinical consultations increasingly occur remotely. We aimed to learn why safety incidents occur in remote encounters and how to prevent them. Setting and sample UK primary care. 95 safety incidents (complaints, settled indemnity claims and reports) involving remote interactions. Separately, 12 general practices followed 2021-2023. Methods Multimethod qualitative study. We explored causes of real safety incidents retrospectively ('Safety I' analysis). In a prospective longitudinal study, we used interviews and ethnographic observation to produce individual, organisational and system-level explanations for why safety and near-miss incidents (rarely) occurred and why they did not occur more often ('Safety II' analysis). Data were analysed thematically. An interpretive synthesis of why safety incidents occur, and why they do not occur more often, was refined following member checking with safety experts and lived experience experts. Results Safety incidents were characterised by inappropriate modality, poor rapport building, inadequate information gathering, limited clinical assessment, inappropriate pathway (eg, wrong algorithm) and inadequate attention to social circumstances. These resulted in missed, inaccurate or delayed diagnoses, underestimation of severity or urgency, delayed referral, incorrect or delayed treatment, poor safety netting and inadequate follow-up. Patients with complex pre-existing conditions, cardiac or abdominal emergencies, vague or generalised symptoms, safeguarding issues, failure to respond to previous treatment or difficulty communicating seemed especially vulnerable. General practices were facing resource constraints, understaffing and high demand. Triage and care pathways were complex, hard to navigate and involved multiple staff. In this context, patient safety often depended on individual staff taking initiative, speaking up or personalising solutions. Conclusion While safety incidents are extremely rare in remote primary care, deaths and serious harms have resulted. We offer suggestions for patient, staff and system-level mitigations.
Effectiveness of behavioural interventions with motivational interviewing on physical activity outcomes in adults: Systematic review and meta-analysis
Objective: To evaluate the effectiveness of behavioural interventions that include motivational interviewing on physical activity outcomes in adults. Design: Systematic review and meta-analysis. Study selection: A search of seven databases for randomised controlled trials published from inception to 1 March 2023 comparing a behavioural intervention including motivational interviewing with a comparator without motivational interviewing on physical activity outcomes in adults. Outcomes of interest were differences in change in quantitative measures of total physical activity, moderate to vigorous physical activity (MVPA), and sedentary time. Data extraction and synthesis: Two reviewers extracted data and assessed risk of bias. Population characteristics, intervention components, comparison groups, and outcomes of studies were summarised. For overall main effects, random effects meta-analyses were used to report standardised mean differences (SMDs) and 95% confidence intervals (CIs). Differential effects based on duration of follow-up, comparator type, intervention duration, and disease or health condition of participants were also examined. Results: 129 papers reporting 97 randomised controlled trials totalling 27 811 participants and 105 comparisons were included. Interventions including motivational interviewing were superior to comparators for increases in total physical activity (SMD 0.45, 95% CI 0.33 to 0.65, equivalent to 1323 extra steps/day; low certainty evidence) and MVPA (0.45, 0.19 to 0.71, equivalent to 95 extra min/week; very low certainty evidence) and for reductions in sedentary time (-0.58, -1.03 to -0.14, equivalent to -51 min/day; very low certainty evidence). Evidence for a difference in any outcome compared with comparators of similar intensity was lacking. The magnitude of effect diminished over time, and evidence of an effect of motivational interviewing beyond one year was lacking. Most interventions involved patients with a specific health condition, and evidence of an effect of motivational interviewing to increase MVPA or decrease sedentary time was lacking in general population samples. Conclusions: Certainty of the evidence using motivational interviewing as part of complex behavioural interventions for promoting total physical activity in adults was low, and for MVPA and sedentary time was very low. The totality of evidence suggests that although interventions with motivational interviewing increase physical activity and decrease sedentary behaviour, no difference was found in studies where the effect of motivational interviewing could be isolated. Effectiveness waned over time, with no evidence of a benefit of motivational interviewing to increase physical activity beyond one year.
Benefits of aldosterone receptor antagonism in chronic kidney disease: the BARACK-D RCT.
BACKGROUND: Chronic kidney disease affects around 10% of the global population and is associated with significant risk of progression to end-stage renal disease and vascular events. Aldosterone receptor antagonists such as spironolactone have shown prognostic benefits in patients with heart failure, but effects on patients with chronic kidney disease are uncertain. OBJECTIVES: To determine the effect of low-dose spironolactone on mortality and cardiovascular outcomes in people with chronic kidney disease stage 3b. DESIGN: Prospective randomised open blinded end-point trial. SETTINGS: Three hundred and twenty-nine general practitioner practices throughout the United Kingdom. PARTICIPANTS: Patients meeting the criteria for chronic kidney disease stage 3b (estimated glomerular filtration rate 30-44 ml/minute/1.73 m2) according to National Institute for Health and Care Excellence guidelines were recruited. Due to the higher than anticipated measurement error/fluctuations, the eligible range was extended to 30-50 ml/minute/1.73 m2 following the initial recruitment period. INTERVENTION: Participants were randomised 1 : 1 to receive either spironolactone 25 mg once daily in addition to standard care, or standard care only. OUTCOME MEASURES: Primary outcome was the first occurring of all-cause mortality, first hospitalisation for heart disease (coronary heart disease, arrhythmia, atrial fibrillation, sudden death, failed sudden death), stroke, heart failure, transient ischaemic attack or peripheral arterial disease, or first occurrence of any condition not listed at baseline. Secondary outcome measures included changes in blood pressure, renal function, B-type natriuretic peptide, incidence of hyperkalaemia and treatment costs and benefits. RESULTS: One thousand four hundred and thirty-four participants were randomised of the 3022 planned. We found no evidence of differences between the intervention and control groups in terms of effectiveness with the primary combined vascular end points, nor with the secondary clinical outcomes, including progression in renal decline. These results were similar for the total treatment periods or a 3-year follow-up period as originally planned. More adverse events were experienced and more participants discontinued treatment in the intervention group. Two-thirds of participants randomised to spironolactone stopped treatment within six months because they met pre-specified safety stop criteria. The addition of low-dose spironolactone was estimated to have a cost per quality-adjusted life-year gained value above the National Institute for Health and Care Excellence's threshold of £30,000. LIMITATIONS: Main limitations were difficulties in recruiting eligible participants resulting in an underpowered trial with poor ethnic diversity taking twice as long as planned to complete. We have explored the data in secondary analyses that indicate that, despite these difficulties, the findings were reliable. CONCLUSIONS: The benefits of aldosterone receptor antagonism in chronic kidney disease trial found no evidence to support adding low-dose spironolactone (25 mg daily) in patients with chronic kidney disease stage 3b: there were no changes to cardiovascular events during the trial follow-up, either for the combined primary or individual components. There was also no evidence of benefit observed in rates of renal function decline over the trial, but much higher initial creatinine rise and estimated glomerular filtration rate decline, and to a higher percentage rate, in the intervention arm in the first few weeks of spironolactone treatment, which resulted in a high proportion of participants discontinuing spironolactone treatment at an early stage. These higher rates of negative renal change reduced in scale over the study but did not equalise between arms. The addition of 25 mg of spironolactone therefore provided no reno- or cardio-protection and was associated with an increase in adverse events. FUTURE WORK: These findings might not be applicable to different mineralocorticoid receptor antagonists. STUDY REGISTRATION: Current Controlled Trials ISRCTN44522369. FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/01/52) and is published in full in Health Technology Assessment; Vol. 29, No. 5. See the NIHR Funding and Awards website for further award information.