BACKGROUND Routinely recorded primary care data have been used for many years by sentinel networks for surveillance. More recently, real world data have been used for a wider range of research projects to support rapid, inexpensive clinical trials. Because the partial national lockdown in the United Kingdom due to the coronavirus disease (COVID-19) pandemic has resulted in decreasing community disease incidence, much larger numbers of general practices are needed to deliver effective COVID-19 surveillance and contribute to in-pandemic clinical trials. OBJECTIVE The aim of this protocol is to describe the rapid design and development of the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) and its first two platforms. The Surveillance Platform will provide extended primary care surveillance, while the Trials Platform is a streamlined clinical trials platform that will be integrated into routine primary care practice. METHODS We will apply the FAIR (Findable, Accessible, Interoperable, and Reusable) metadata principles to a new, integrated digital health hub that will extract routinely collected general practice electronic health data for use in clinical trials and provide enhanced communicable disease surveillance. The hub will be findable through membership in Health Data Research UK and European metadata repositories. Accessibility through an online application system will provide access to study-ready data sets or developed custom data sets. Interoperability will be facilitated by fixed linkage to other key sources such as Hospital Episodes Statistics and the Office of National Statistics using pseudonymized data. All semantic descriptors (ie, ontologies) and code used for analysis will be made available to accelerate analyses. We will also make data available using common data models, starting with the US Food and Drug Administration Sentinel and Observational Medical Outcomes Partnership approaches, to facilitate international studies. The Surveillance Platform will provide access to data for health protection and promotion work as authorized through agreements between Oxford, the Royal College of General Practitioners, and Public Health England. All studies using the Trials Platform will go through appropriate ethical and other regulatory approval processes. RESULTS The hub will be a bottom-up, professionally led network that will provide benefits for member practices, our health service, and the population served. Data will only be used for SQUIRE (surveillance, quality improvement, research, and education) purposes. We have already received positive responses from practices, and the number of practices in the network has doubled to over 1150 since February 2020. COVID-19 surveillance has resulted in tripling of the number of virology sites to 293 (target 300), which has aided the collection of the largest ever weekly total of surveillance swabs in the United Kingdom as well as over 3000 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology samples. Practices are recruiting to the PRINCIPLE (Platform Randomised trial of INterventions against COVID-19 In older PeopLE) trial, and these participants will be followed up through ORCHID. These initial outputs demonstrate the feasibility of ORCHID to provide an extended national digital health hub. CONCLUSIONS ORCHID will provide equitable and innovative use of big data through a professionally led national primary care network and the application of FAIR principles. The secure data hub will host routinely collected general practice data linked to other key health care repositories for clinical trials and support enhanced in situ surveillance without always requiring large volume data extracts. ORCHID will support rapid data extraction, analysis, and dissemination with the aim of improving future research and development in general practice to positively impact patient care. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19773
Background Colchicine has been proposed as a COVID-19 treatment. Aim To determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community. Design and setting Prospective, multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial (PRINCIPLE). Method Adults aged ≥65 years or ≥18 years with comorbidities or shortness of breath, and unwell for ≤14 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 µg daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models. Results The trial opened on 2 April 2020. Randomisation to colchicine started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met. The primary analysis model included 2755 participants who were SARS-CoV-2 positive, randomised to colchicine ( n = 156), usual care ( n = 1145), and other treatments ( n = 1454). Time to first self-reported recovery was similar in the colchicine group compared with usual care with an estimated hazard ratio of 0.92 (95% credible interval (CrI) = 0.72 to 1.16) and an estimated increase of 1.4 days in median time to self-reported recovery for colchicine versus usual care. The probability of meaningful benefit in time to recovery was very low at 1.8%. COVID-19-related admissions to hospital/deaths were similar in the colchicine group versus usual care, with an estimated odds ratio of 0.76 (95% CrI = 0.28 to 1.89) and an estimated difference of −0.4% (95% CrI = −2.7 to 2.4). Conclusion Colchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.
Abstract Background It remains unclear to what extent reductions in urgent referrals for suspected cancer during the COVID-19 pandemic were the result of fewer patients attending primary care compared to GPs referring fewer patients. Methods Cohort study including electronic health records data from 8,192,069 patients from 663 English practices. Weekly consultation rates, cumulative consultations and referrals were calculated for 28 clinical features from the NICE suspected cancer guidelines. Clinical feature consultation rate ratios (CRR) and urgent referral rate ratios (RRR) compared time periods in 2020 with 2019. Findings Consultations for cancer clinical features decreased by 24.19% (95% CI: 24.04–24.34%) between 2019 and 2020, particularly in the 6–12 weeks following the first national lockdown. Urgent referrals for clinical features decreased by 10.47% (95% CI: 9.82–11.12%) between 2019 and 2020. Overall, once patients consulted with primary care, GPs urgently referred a similar or greater proportion of patients compared to previous years. Conclusion Due to the significant fall in patients consulting with clinical features of cancer there was a lower than expected number of urgent referrals in 2020. Sustained efforts should be made throughout the pandemic to encourage the public to consult their GP with cancer clinical features.
Abstract Objective To quantify the impact and recovery in cardiovascular disease monitoring in primary care associated with the first COVID-19 lockdown. Design Retrospective nationwide primary care cohort study, utilising data from 1st January 2018 to 27 th September 2020. Setting We extracted primary care electronic health records data from 514 primary care practices in England contributing to the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID). These practices were representative of English primary care across urban and non-urban practices. Participants The ORCHID database included 6,157,327 active patients during the study period, and 13,938,390 patient years of observation (final date of follow-up 27 th September 2020). The mean (SD) age was 38±24 years, 49.4% were male and the majority were of white ethnicity (65% [21.9% had unknown ethnicity]) Exposure The primary exposure was the first national lockdown in the UK, starting on 23 rd March 2020. Main outcome measures Records of cholesterol, blood pressure, HbA1c and International Normalised Ratio (INR) measurement derived from coded entries in the primary care electronic health record. Results Rates of cholesterol, blood pressure, HbA1c and INR recording dropped by 23-87% in the week following the first UK national lockdown, compared with the previous week. The largest decline was seen in cholesterol (IRR 0.13, 95% CI 0.11 to 0.15) and smallest for INR (IRR 0.77, 95% CI 0.72 to 0.81). Following the immediate drop, rates of recorded tests increased on average by 5-9% per week until 27 th September 2020. However, the number of recorded measures remained below that expected for the time of year, reaching 51.8% (95% CI 51.8 to 51.9%) for blood pressure, 63.7%, (95% CI 63.7% to 63.8%) for cholesterol measurement and 70.3% (95% CI 70.2% to 70.4%) for HbA1c. Rates of INR recording declined throughout the previous two years, a trend that continued after lockdown. There were no differences in the times series trends based on sex, age, ethnicity or deprivation. Conclusions Cardiovascular disease monitoring in English primary care declined substantially from the time of the first UK lockdown. Despite a consistent recovery in activity, there is still a substantial shortfall in the numbers of recorded measurements to those expected. Strategies are required to ensure cardiovascular disease monitoring is maintained during the COVID-19 pandemic.
Key Points A randomized controlled trial demonstrates that a simple and cheap 1-month intervention empowers people with CKD to lower their dietary salt intake. The effect of the intervention persisted after the intervention finished. Background To evaluate the efficacy of a simple low-cost intervention to empower people with CKD to reduce their dietary salt intake. Methods A randomized controlled trial in primary and secondary care comparing the OxSalt care bundle intervention versus standard care for 1 month. Participants were people with CKD and an eGFR >20 ml/min per 1.73 m 2 and were recruited from primary and secondary care. The primary outcome was a reduction in dietary salt intake, as assessed by 24-hour urinary sodium excretion, after 1 month of the intervention. Results Two hundred and one participants were recruited. Dietary salt intake, as assessed from 24-hour urine sodium excretion, fell by 1.9 (±2.9) g/d in the intervention group compared with 0.4 (±2.7) g/d in the control group ( P < 0.001). Salt intake was still reduced to a lesser extent over the following year in the intervention group. Conclusions A short, low-cost, easily delivered intervention empowers people with CKD to reduce their dietary salt intake. Trial registration ClinicalTrials.gov NCT01552317.
Severe acute respiratory syndrome (SARS) is now a global public health threat with many medical, ethical, social, economic, political, and legal implications. (Abdullah et al. 2003 Abdullah ASM 2003 ‘Lessons from the severe acute respiratory syndrome outbreak in Hong Kong’ Emerging Infectious Diseases Journal [online] September. Available from: URL: http://www.cdc.gov/ncidod/EID/vol9no9/03–0366.htm [Crossref] , [Google Scholar]) No man is an island. (John Donne) The security of the state is dependent on the security of its individual citizens. If they are not secure, the state is not secure. Traditional, state‐dominant, conceptions of security are ill‐equipped to provide understanding into the array of security concerns that now confront nation‐states. In November 2002, one of these new security concerns, a corona pulmonary virus jumped the species barrier to begin infecting people in southern China. Three months later this virus was unwittingly transmitted from mainland China to Hong Kong. From there it spread rapidly throughout most of Southeast Asia as well as through parts of the Americas and Europe. Now known as the SARS—Severe Acute Respiratory Syndrome—virus, it became a major threat to the stability and prosperity of Southeast Asian countries. This article reviews the spread and impact of the SARS virus within Southeast Asia from a human security perspective. It is intended that the utilisation of human security in this instance will not only provide a better understanding of the impact of SARS on regional states but will also advance the conceptualisation of the human security model.
Background: Islet autoantibody screening for type 1 diabetes (T1D) reduces life-threatening diabetic ketoacidosis, hospitalization and identifies individuals eligible for future preventative treatments. 3.5-4 years has been indicated as an optimal time to screen younger children for T1D at a single-time point. We therefore assessed the feasibility and acceptability of screening at this age, to align with the pre-school vaccination visit, in a first of its kind, proof-of-concept study in the UK. Methods: Children attending routine pre-school vaccinations (n= 63; median age 3.5y (IQR 3.4-3.6, range 3.1-5.1y), 26 (41.3%) male) provided capillary blood samples which were posted for IAA, GADA, IA-2A and ZnT8A analysis. Serum volumes >60µL were tested using Radiobinding assay (RBA), and <60µL by Luciferase Immunoprecipitation Systems (LIPS) assay. Acceptability was assessed using open question postcards, and semi structured interviews. Results: There was 97% (61/63 samples) success in sample analysis, with median serum collected 100µL (IQR 80-155) and 83% (52/63)>60µL. One participant screened and confirmed positive by RBA for IAA. Participants (n=15 interviews, n=31 postcards) were uniformly positive about screening aligning to the vaccination programme, citing that they may have been less likely to take part had screening been a separate visit. Themes identified included being prepared in the event of a T1D diagnosis, feeling reassured by a negative test result, and the long-term benefit of screening outweighing short-term upset. Parents reported that the volume of blood was higher, and collection time longer than expected. Conclusions: Capillary islet autoantibody testing is a feasible and acceptable method to screen children for T1D. Aligning sample collection to the pre-school vaccination was not a deterrent to vaccination. The approach of combining screening with a routine health visit may enable uptake and could be cost saving. Disclosure C. Scudder: None. J. Townson: None. R. Besser: Consultant; Provention Bio, Inc. J. Bowen-morris: None. P. H. Evans: None. S. C. Jones: None. N. P. B. Thomas: None. R. Fox: None. J. Todd: Advisory Panel; GlaxoSmithKline plc., Precion, Qlife, Vesalius Therapeutics. S. Greenfield: None. C. Dayan: Advisory Panel; AstraZeneca, Consultant; Provention Bio, Sanofi, Avotres Inc., Other Relationship; Dompé, Merck & Co., Inc. Funding National Institute for Health Research (203948)
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