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BackgroundDuring the pandemic, remote consultations have become the norm for assessing patients with signs and symptoms of COVID-19 to decrease the risk of transmission. This has intensified the clinical uncertainty already experienced by primary care clinicians when assessing patients with suspected COVID-19 and has prompted the use of risk prediction scores, such as the National Early Warning Score (NEWS2), to assess severity and guide treatment. However, the risk prediction tools available have not been validated in a community setting and are not designed to capture the idiosyncrasies of COVID-19 infection. ObjectiveThe objective of this study is to produce a multivariate risk prediction tool, RECAP-V1 (Remote COVID-19 Assessment in Primary Care), to support primary care clinicians in the identification of those patients with COVID-19 that are at higher risk of deterioration and facilitate the early escalation of their treatment with the aim of improving patient outcomes. MethodsThe study follows a prospective cohort observational design, whereby patients presenting in primary care with signs and symptoms suggestive of COVID-19 will be followed and their data linked to hospital outcomes (hospital admission and death). Data collection will be carried out by primary care clinicians in four arms: North West London Clinical Commissioning Groups (NWL CCGs), Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), Covid Clinical Assessment Service (CCAS), and South East London CCGs (Doctaly platform). The study involves the use of an electronic template that incorporates a list of items (known as RECAP-V0) thought to be associated with disease outcome according to previous qualitative work. Data collected will be linked to patient outcomes in highly secure environments. We will then use multivariate logistic regression analyses for model development and validation. ResultsRecruitment of participants started in October 2020. Initially, only the NWL CCGs and RCGP RSC arms were active. As of March 24, 2021, we have recruited a combined sample of 3827 participants in these two arms. CCAS and Doctaly joined the study in February 2021, with CCAS starting the recruitment process on March 15, 2021. The first part of the analysis (RECAP-V1 model development) is planned to start in April 2021 using the first half of the NWL CCGs and RCGP RSC combined data set. Posteriorly, the model will be validated with the rest of the NWL CCGs and RCGP RSC data as well as the CCAS and Doctaly data sets. The study was approved by the Research Ethics Committee on May 27, 2020 (Integrated Research Application System number: 283024, Research Ethics Committee reference number: 20/NW/0266) and badged as National Institute of Health Research Urgent Public Health Study on October 14, 2020. ConclusionsWe believe the validated RECAP-V1 early warning score will be a valuable tool for the assessment of severity in patients with suspected COVID-19 in the community, either in face-to-face or remote consultations, and will facilitate the timely escalation of treatment with the potential to improve patient outcomes. Trial RegistrationISRCTN registry ISRCTN13953727; https://www.isrctn.com/ISRCTN13953727 International Registered Report Identifier (IRRID)DERR1-10.2196/29072

BackgroundAtrial fibrillation (AF) is one of the commonest arrhythmias observed in general practice. The thromboembolic complications of AF include transient ischemic attack, stroke, and pulmonary embolism. Early recognition of AF can lead to early intervention with managing the risks of these complications. ObjectiveThe primary aim of this study is to investigate if patients are managed in general practice according to current national guidelines. In addition, the study will evaluate the impact of direct oral anticoagulant use with respect to AF complications in a real-world dataset. The secondary aims of the study are to develop a dashboard that will allow monitoring the management of AF in general practice and evaluate the usability of the dashboard. MethodsThe study was conducted in 2 phases. The initial phase was a quantitative analysis of routinely collected primary care data from the Oxford Royal College of General Practitioners Research and Surveillance Center (RCGP RSC) sentinel network database. AF cases from 2009 to 2019 were identified. The study investigated the impact of the use of anticoagulants on complications of AF over this time period. We used this dataset to examine how AF was managed in primary care during the last decade. The second phase involved development of an online dashboard for monitoring management of AF in general practice. We conducted a usability evaluation for the dashboard to identify usability issues and performed enhancements to improve usability. ResultsWe received funding for both phases in January 2019 and received approval from the RCGP RSC research committee in March 2019. We completed data extraction for phase 1 in May 2019 and completed analysis in December 2019. We completed building the AF dashboard in May 2019. We started recruiting participants for phase 1 in May 2019 and concluded data collection in July 2019. We completed data analysis for phase 2 in October 2019. The results are expected to be published in the second half of 2020. As of October 2020, the publications reporting the results are under review. ConclusionsResults of this study will provide an insight into the current trends in management of AF using real-world data from the Oxford RCGP RSC database. We anticipate that the outcomes of this study will be used to guide the development and implementation of an audit-based intervention tool to assist practitioners in identifying and managing AF in primary care. International Registered Report Identifier (IRRID)RR1-10.2196/21259

Background: Social distancing and other nonpharmaceutical interventions to reduce the spread of COVID-19 infection in the United Kingdom have led to substantial changes in delivering ongoing care for patients with chronic conditions, including type 2 diabetes mellitus (T2DM). Clinical guidelines for the management and prevention of complications for people with T2DM delivered in primary care services advise routine annual reviews and were developed when face-to-face consultations were the norm. The shift in consultations from face-to-face to remote consultations caused a reduction in direct clinical contact and may impact the process of care for people with T2DM. Objective: The aim of this study is to explore the impact of the COVID-19 pandemic’s first year on the monitoring of people with T2DM using routine annual reviews from a national primary care perspective in England. Methods: A retrospective cohort study of adults with T2DM will be performed using routinely collected primary care data from the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). We will describe the change in the rate of monitoring of hemoglobin A1c (HbA1c) between the first year of the COVID-19 pandemic (2020) and the preceding year (2019). We will also report any change in the eight checks that make up the components of these reviews. The change in HbA1c monitoring rates will be determined using a multilevel logistic regression model, adjusting for patient and practice characteristics, and similarly, the change in a composite measure of the completeness of all eight checks will be modeled using ordinal regression. The models will be adjusted for the following patient-level variables: age, gender, socioeconomic status, ethnicity, COVID-19 shielding status, duration of diabetes, and comorbidities. The model will also be adjusted for the following practice-level variables: urban versus rural, practice size, Quality and Outcomes Framework achievement, the National Health Service region, and the proportion of face-to-face consultations. Ethical approval was provided by the University of Oxford Medical Sciences Interdivisional Research Ethics Committee (September 2, 2021, reference R77306/RE001). Results: The analysis of the data extract will include 3.96 million patients with T2DM across 700 practices, which is 6% of the available Oxford-RCGP RSC adult population. The preliminary results will be submitted to a conference under the domain of primary care. The resulting publication will be submitted to a peer-reviewed journal on diabetes and endocrinology. Conclusions: The COVID-19 pandemic has impacted the delivery of care, but little is known about the process of caring for people with T2DM. This study will report the impact of the COVID-19 pandemic on these processes of care. [ABSTRACT FROM AUTHOR]

Background: Globally, there are marked inconsistencies in how immunosuppression is characterized and subdivided into clinical risk groups. This is detrimental to the precision and comparability of disease surveillance efforts-which has negative implications for the care of those who are immunosuppressed and their health outcomes. This was particularly apparent during the COVID-19 pandemic; despite collective motivation to protect these patients, conflicting clinical definitions created international rifts in how those who were immunosuppressed were monitored and managed during this period. We propose that international clinical consensus be built around the conditions that lead to immunosuppression and their gradations of severity concerning COVID-19. Such information can then be formalized into a digital phenotype to enhance disease surveillance and provide much-needed intelligence on risk-prioritizing these patients., Objective: We aim to demonstrate how electronic Delphi objectives, methodology, and statistical approaches will help address this lack of consensus internationally and deliver a COVID-19 risk-stratified phenotype for "adult immunosuppression.", Methods: Leveraging existing evidence for heterogeneous COVID-19 outcomes in adults who are immunosuppressed, this work will recruit over 50 world-leading clinical, research, or policy experts in the area of immunology or clinical risk prioritization. After 2 rounds of clinical consensus building and 1 round of concluding debate, these panelists will confirm the medical conditions that should be classed as immunosuppressed and their differential vulnerability to COVID-19. Consensus statements on the time and dose dependencies of these risks will also be presented. This work will be conducted iteratively, with opportunities for panelists to ask clarifying questions between rounds and provide ongoing feedback to improve questionnaire items. Statistical analysis will focus on levels of agreement between responses., Results: This protocol outlines a robust method for improving consensus on the definition and meaningful subdivision of adult immunosuppression concerning COVID-19. Panelist recruitment took place between April and May of 2024; the target set for over 50 panelists was achieved. The study launched at the end of May and data collection is projected to end in July 2024., Conclusions: This protocol, if fully implemented, will deliver a universally acceptable, clinically relevant, and electronic health record-compatible phenotype for adult immunosuppression. As well as having immediate value for COVID-19 resource prioritization, this exercise and its output hold prospective value for clinical decision-making across all diseases that disproportionately affect those who are immunosuppressed., International Registered Report Identifier (irrid): PRR1-10.2196/56271., (©Meredith Leston, José Ordóñez-Mena, Mark Joy, Simon de Lusignan, Richard Hobbs, Iain McInnes, Lennard Lee. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.06.2024.)