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Masks help prevent the spread of SARS-CoV-2, the virus that causes COVID-19, yet masking policies in the west have featured some spectacular policy wrong turns, says Professor Trish Greenhalgh.
Strategies to implement SARS-CoV-2 point-of-care testing into primary care settings: a qualitative secondary analysis guided by the Behaviour Change Wheel
Background: The purpose of this study is to develop a theory-driven understanding of the barriers and facilitators underpinning physicians’ attitudes and capabilities to implementing SARS-CoV-2 point-of-care (POC) testing into primary care practices. Methods: We used a secondary qualitative analysis approach to re-analyse data from a qualitative, interview study of 22 primary care physicians from 21 primary care practices across three regions in England. We followed the three-step method based on the Behaviour Change Wheel to identify the barriers to implementing SARS-CoV-2 POC testing and identified strategies to address these challenges. Results: Several factors underpinned primary care physicians’ attitudes and capabilities to implement SARS-CoV-2 POC testing into practice. First, limited knowledge of the SARS-CoV-2 POC testing landscape and a demanding workload affected physicians’ willingness to use the tests. Second, there was scepticism about the insufficient evidence pertaining to the clinical efficacy and utility of POC tests, which affected physicians’ confidence in the accuracy of tests. Third, physicians would adopt POC tests if they were prescribed and recommended by authorities. Fourth, physicians required professional education and training to increase their confidence in using POC tests but also suggested that healthcare assistants should administer the tests. Fifth, physicians expressed concerns about their limited workload capacity and that extra resources are needed to accommodate any anticipated changes. Sixth, information sharing across practices shaped perceptions of POC tests and the quality of information influenced physician perceptions. Seventh, financial incentives could motivate physicians and were also needed to cover the associated costs of testing. Eighth, physicians were worried that society will view primary care as an alternative to community testing centres, which would change perceptions around their professional identity. Ninth, physicians’ perception of assurance/risk influenced their willingness to use POC testing if it could help identify infectious individuals, but they were also concerned about the risk of occupational exposure and potentially losing staff members who would need to self-isolate. Conclusions: Improving primary care physicians’ knowledgebase of SARS-CoV-2 POC tests, introducing policies to embed testing into practice, and providing resources to meet the anticipated demands of testing are critical to implementing testing into practice.
First dose COVID-19 vaccine coverage amongst adolescents and children in England: an analysis of 3.21 million patients' primary care records in situ using OpenSAFELY.
Background: The coronavirus disease 2019 (COVID-19) vaccination programme in England was extended to include all adolescents and children by April 2022. The aim of this paper is to describe trends and variation in vaccine coverage in different clinical and demographic groups amongst adolescents and children in England by August 2022. Methods: With the approval of NHS England, a cohort study was conducted of 3.21 million children and adolescents' records in general practice in England, in situ and within the infrastructure of the electronic health record software vendor TPP using OpenSAFELY. Vaccine coverage across various demographic (sex, deprivation index and ethnicity) and clinical (risk status) populations is described. Results: Coverage is higher amongst adolescents than it is amongst children, with 53.5% adolescents and 10.8% children having received their first dose of the COVID-19 vaccine. Within those groups, coverage varies by ethnicity, deprivation index and risk status; there is no evidence of variation by sex. Conclusion: First dose COVID-19 vaccine coverage is shown to vary amongst various demographic and clinical groups of children and adolescents.
Investigating the prescribing trajectory and geographical drug utilisation patterns of gabapentinoids in primary care in England: An ecological study
Aims: This study aimed to investigate the prescribing trajectory, geographical variation and population factors, including socioeconomic status (SES), related to prescribing gabapentinoids in primary care in England. Methods: This ecological study applied practice-level dispensing data and statistics from the UK National Health Service Digital and Office for National Statistics from 2013 to 2019. The prescribing of gabapentinoids (in defined daily doses [DDDs]/1000 people) was measured annually and quarterly. General practices were categorised according to the quarterly prescribing in a group-based trajectory model. The one-year prescribing in 2018/19 was associated with practice-level covariates in a mixed-effects multilevel regression, adjusted for the cluster-effects of Clinical Commissioning Groups (CCGs) and mapped geographically. Results: The annual national prescription rate increased by 70% from 2800 to 4773 DDDs/1000 people in the time period 2013/14 to 2018/19. General practices were stratified into six trajectory groups. Practices with the highest level and the greatest increase in prescribing (n = 789; 9.8%) are mainly located in the north of England and along the east and south coastline. Socioeconomic status, demographic characteristics and relevant disease conditions were significantly associated with the prescribing. For every decrease in the Index of Multiple Deprivation decile (becoming less affluent), prescribing of gabapentinoids increased significantly by 203 (95% CI: 183–222) DDDs/1000 registrants. Conclusions: Gabapentinoid prescribing trajectories varied across geographical regions and are associated with socioeconomic status, CCG locality (geography) and other population characteristics. These factors should be considered in future studies investigating the determinants of gabapentinoid prescribing and the risk of harms associated with gabapentinoids.
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.
End of 2022/23 Season Influenza Vaccine Effectiveness in Primary Care in Great Britain.
BACKGROUND: The 2022/23 influenza season in the United Kingdom saw the return of influenza to prepandemic levels following two seasons with low influenza activity. The early season was dominated by A(H3N2), with cocirculation of A(H1N1), reaching a peak late December 2022, while influenza B circulated at low levels during the latter part of the season. From September to March 2022/23, influenza vaccines were offered, free of charge, to all aged 2-13 (and 14-15 in Scotland and Wales), adults up to 49 years of age with clinical risk conditions and adults aged 50 and above across the mainland United Kingdom. METHODS: End-of-season adjusted vaccine effectiveness (VE) estimates against sentinel primary-care attendance for influenza-like illness, where influenza infection was laboratory confirmed, were calculated using the test negative design, adjusting for potential confounders. METHODS: Results In the mainland United Kingdom, end-of-season VE against all laboratory-confirmed influenza for all those > 65 years of age, most of whom received adjuvanted quadrivalent vaccines, was 30% (95% CI: -6% to 54%). VE for those aged 18-64, who largely received cell-based vaccines, was 47% (95% CI: 37%-56%). Overall VE for 2-17 year olds, predominantly receiving live attenuated vaccines, was 66% (95% CI: 53%-76%). CONCLUSION: The paper provides evidence of moderate influenza VE in 2022/23.
Patient and stakeholder engagement on the role that Social Prescribing might play in supporting the health and wellbeing of people diagnosed with Mild Cognitive Impairment
There is no standardised clinical care for people with mild cognitive impairment (MCI) postdiagnosis. Social prescribing could potentially address this gap, as it enables people to access a range of non-clinical organisations and activities to support their health and wellbeing. However there has been little research on the role of social prescribing specifically for people living with MCI. This project entailed Patient and Public Involvement (PPI) in order to inform the development of future research in this area. We invited people with MCI to talk to us about their experiences of life with the condition and about any impact those memory problems had on their lives. An anonymised film of public contributors’ inputs was created and shared with a range of healthcare professionals, to prompt their reflections on the potential benefits and challenges of offering social prescribing to patients with MCI. There was consensus among public and professional contributors that social prescribing could offer opportunities for patients to address social isolation and to mitigate the impacts of MCI and linked conditions (e.g. anxiety) on cognitive and social functioning. We recommend as the next step a feasibility study to assess the acceptability and logistics of social prescribing among patients with MCI and the healthcare professionals who support them, on a larger scale and for a more sustained period than was possible in this preliminary work.
Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study
Background: Analysis of circulating tumour DNA could stratify cancer risk in symptomatic patients. We aimed to evaluate the performance of a methylation-based multicancer early detection (MCED) diagnostic test in symptomatic patients referred from primary care. Methods: We did a multicentre, prospective, observational study at National Health Service (NHS) hospital sites in England and Wales. Participants aged 18 or older referred with non-specific symptoms or symptoms potentially due to gynaecological, lung, or upper or lower gastrointestinal cancers were included and gave a blood sample when they attended for urgent investigation. Participants were excluded if they had a history of or had received treatment for an invasive or haematological malignancy diagnosed within the preceding 3 years, were taking cytotoxic or demethylating agents that might interfere with the test, or had participated in another study of a GRAIL MCED test. Patients were followed until diagnostic resolution or up to 9 months. Cell-free DNA was isolated and the MCED test performed blinded to the clinical outcome. MCED predictions were compared with the diagnosis obtained by standard care to establish the primary outcomes of overall positive and negative predictive value, sensitivity, and specificity. Outcomes were assessed in participants with a valid MCED test result and diagnostic resolution. SYMPLIFY is registered with ISRCTN (ISRCTN10226380) and has completed follow-up at all sites. Findings: 6238 participants were recruited between July 7 and Nov 30, 2021, across 44 hospital sites. 387 were excluded due to staff being unable to draw blood, sample errors, participant withdrawal, or identification of ineligibility after enrolment. Of 5851 clinically evaluable participants, 376 had no MCED test result and 14 had no information as to final diagnosis, resulting in 5461 included in the final cohort for analysis with an evaluable MCED test result and diagnostic outcome (368 [6·7%] with a cancer diagnosis and 5093 [93·3%] without a cancer diagnosis). The median age of participants was 61·9 years (IQR 53·4–73·0), 3609 (66·1%) were female and 1852 (33·9%) were male. The MCED test detected a cancer signal in 323 cases, in whom 244 cancer was diagnosed, yielding a positive predictive value of 75·5% (95% CI 70·5–80·1), negative predictive value of 97·6% (97·1–98·0), sensitivity of 66·3% (61·2–71·1), and specificity of 98·4% (98·1–98·8). Sensitivity increased with increasing age and cancer stage, from 24·2% (95% CI 16·0–34·1) in stage I to 95·3% (88·5–98·7) in stage IV. For cases in which a cancer signal was detected among patients with cancer, the MCED test's prediction of the site of origin was accurate in 85·2% (95% CI 79·8–89·3) of cases. Sensitivity 80·4% (95% CI 66·1–90·6) and negative predictive value 99·1% (98·2–99·6) were highest for patients with symptoms mandating investigation for upper gastrointestinal cancer. Interpretation: This first large-scale prospective evaluation of an MCED diagnostic test in a symptomatic population demonstrates the feasibility of using an MCED test to assist clinicians with decisions regarding urgency and route of referral from primary care. Our data provide the basis for a prospective, interventional study in patients presenting to primary care with non-specific signs and symptoms. Funding: GRAIL Bio UK.
Phenotype execution and modeling architecture to support disease surveillance and real-world evidence studies: English sentinel network evaluation.
OBJECTIVE: To evaluate Phenotype Execution and Modelling Architecture (PhEMA), to express sharable phenotypes using Clinical Quality Language (CQL) and intensional Systematised Nomenclature of Medicine (SNOMED) Clinical Terms (CT) Fast Healthcare Interoperability Resources (FHIR) valuesets, for exemplar chronic disease, sociodemographic risk factor, and surveillance phenotypes. METHOD: We curated 3 phenotypes: Type 2 diabetes mellitus (T2DM), excessive alcohol use, and incident influenza-like illness (ILI) using CQL to define clinical and administrative logic. We defined our phenotypes with valuesets, using SNOMED's hierarchy and expression constraint language, and CQL, combining valuesets and adding temporal elements where needed. We compared the count of cases found using PhEMA with our existing approach using convenience datasets. We assessed our new approach against published desiderata for phenotypes. RESULTS: The T2DM phenotype could be defined as 2 intensionally defined SNOMED valuesets and a CQL script. It increased the prevalence from 7.2% to 7.3%. Excess alcohol phenotype was defined by valuesets that added qualitative clinical terms to the quantitative conceptual definitions we currently use; this change increased prevalence by 58%, from 1.2% to 1.9%. We created an ILI valueset with SNOMED concepts, adding a temporal element using CQL to differentiate new episodes. This increased the weekly incidence in our convenience sample (weeks 26-38) from 0.95 cases to 1.11 cases per 100 000 people. CONCLUSIONS: Phenotypes for surveillance and research can be described fully and comprehensibly using CQL and intensional FHIR valuesets. Our use case phenotypes identified a greater number of cases, whilst anticipated from excessive alcohol this was not for our other variable. This may have been due to our use of SNOMED CT hierarchy. Our new process fulfilled a greater number of phenotype desiderata than the one that we had used previously, mostly in the modeling domain. More work is needed to implement that sharing and warehousing domains.