Royal College Of General Practitioners Research And Surveillance Centre Research Articles

Influenza and Respiratory Virus Surveillance, Vaccine Uptake, and Effectiveness at a Time of Cocirculating COVID-19: Protocol for the English Primary Care Sentinel System for 2020-2021.

BackgroundThe Oxford–Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) and Public Health England (PHE) are commencing their 54th season of collaboration at a time when SARS-CoV-2 infections are likely to be cocirculating with the usual winter infections.ObjectiveThe aim of this study is to conduct surveillance of influenza and other monitored respiratory conditions and to report on vaccine uptake and effectiveness using nationally representative surveillance data extracted from primary care computerized medical records systems. We also aim to have general practices collect virology and serology specimens and to participate in trials and other interventional research.MethodsThe RCGP RSC network comprises over 1700 general practices in England and Wales. We will extract pseudonymized data twice weekly and are migrating to a system of daily extracts. First, we will collect pseudonymized, routine, coded clinical data for the surveillance of monitored and unexpected conditions; data on vaccine exposure and adverse events of interest; and data on approved research study outcomes. Second, we will provide dashboards to give general practices feedback about levels of care and data quality, as compared to other network practices. We will focus on collecting data on influenza-like illness, upper and lower respiratory tract infections, and suspected COVID-19. Third, approximately 300 practices will participate in the 2020-2021 virology and serology surveillance; this will include responsive surveillance and long-term follow-up of previous SARS-CoV-2 infections. Fourth, member practices will be able to recruit volunteer patients to trials, including early interventions to improve COVID-19 outcomes and point-of-care testing. Lastly, the legal basis for our surveillance with PHE is Regulation 3 of the Health Service (Control of Patient Information) Regulations 2002; other studies require appropriate ethical approval.ResultsThe RCGP RSC network has tripled in size; there were previously 100 virology practices and 500 practices overall in the network and we now have 322 and 1724, respectively. The Oxford–RCGP Clinical Informatics Digital Hub (ORCHID) secure networks enable the daily analysis of the extended network; currently, 1076 practices are uploaded. We are implementing a central swab distribution system for patients self-swabbing at home in addition to in-practice sampling. We have converted all our primary care coding to Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) coding. Throughout spring and summer 2020, the network has continued to collect specimens in preparation for the winter or for any second wave of COVID-19 cases. We have collected 5404 swabs and detected 623 cases of COVID-19 through extended virological sampling, and 19,341 samples have been collected for serology. This shows our preparedness for the winter season.ConclusionsThe COVID-19 pandemic has been associated with a groundswell of general practices joining our network. It has also created a permissive environment in which we have developed the capacity and capability of the national primary care surveillance systems and our unique public health institute, the RCGP and University of Oxford collaboration.

COVID-19 Surveillance in a Primary Care Sentinel Network: In-Pandemic Development of an Application Ontology.

BackgroundCreating an ontology for COVID-19 surveillance should help ensure transparency and consistency. Ontologies formalize conceptualizations at either the domain or application level. Application ontologies cross domains and are specified through testable use cases. Our use case was an extension of the role of the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) to monitor the current pandemic and become an in-pandemic research platform.ObjectiveThis study aimed to develop an application ontology for COVID-19 that can be deployed across the various use-case domains of the RCGP RSC research and surveillance activities.MethodsWe described our domain-specific use case. The actor was the RCGP RSC sentinel network, the system was the course of the COVID-19 pandemic, and the outcomes were the spread and effect of mitigation measures. We used our established 3-step method to develop the ontology, separating ontological concept development from code mapping and data extract validation. We developed a coding system–independent COVID-19 case identification algorithm. As there were no gold-standard pandemic surveillance ontologies, we conducted a rapid Delphi consensus exercise through the International Medical Informatics Association Primary Health Care Informatics working group and extended networks.ResultsOur use-case domains included primary care, public health, virology, clinical research, and clinical informatics. Our ontology supported (1) case identification, microbiological sampling, and health outcomes at an individual practice and at the national level; (2) feedback through a dashboard; (3) a national observatory; (4) regular updates for Public Health England; and (5) transformation of a sentinel network into a trial platform. We have identified a total of 19,115 people with a definite COVID-19 status, 5226 probable cases, and 74,293 people with possible COVID-19, within the RCGP RSC network (N=5,370,225).ConclusionsThe underpinning structure of our ontological approach has coped with multiple clinical coding challenges. At a time when there is uncertainty about international comparisons, clarity about the basis on which case definitions and outcomes are made from routine data is essential.

Use and impact of social prescribing: a mixed-methods feasibility study protocol

IntroductionSocial prescribing aims to address social determinants of health, which account for 80%–90% of health outcomes, but the evidence base behind it is limited due to a lack of data...

Epidemiology and management of atopic dermatitis in England: an observational cohort study protocol

IntroductionAtopic dermatitis (AD) is one of the most common inflammatory skin conditions in both children and adults. Despite this, contemporary descriptions of the incidence, prevalence and current management of the...

Does Renal Function or Heart Failure Diagnosis Affect Primary Care Prescribing for Sodium-Glucose Co-Transporter2 Inhibitors in Type2 Diabetes?

IntroductionSodium-glucose co-transporter 2 inhibitors (SGLT2is) are a unique class of drugs currently used in the management of type 2 diabetes (T2D). There are emerging data from cardiovascular outcome trials confirming renal and heart failure benefits of these drugs independent of glucose lowering. By contrast, the current licencing indications of these drugs are mainly limited to their glucose-lowering effects, and not to renal or heart failure benefits. It is therefore timely to ascertain whether the presence of these clinical conditions may influence prescribing choices for patients with T2D. Our aims are to report prescribing of SGLT2is in people with T2D according to their renal function and presence of heart failure. Co-prescribing with diuretics will also be explored.MethodsWe will perform a cross-sectional analysis of people with T2D in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. The RCGP RSC includes more than 1500 volunteer practices throughout England and parts of Wales, and a representative sample of over 10 million patients. The proportion of adults with T2D ever prescribed an SGLT2i will be determined. Within this cohort, we will calculate the percentage of SGLT2is prescribed according to renal function, and the proportion of prescriptions in people with co-morbid heart failure, stratified by body mass index categories. The percentage of SGLT2is prescribed as an add-on to a diuretic or following discontinuation of prescribing for a diuretic will also be reported. Multilevel logistic regression will be performed to explore the association between heart failure and renal function, and propensity to prescribe SGLT2is.Planned OutputsThe study findings will be submitted to a primary care/diabetes-focused conference, and for publication in a peer reviewed journal.

Emergence of a Novel Coronavirus (COVID-19): Protocol for Extending Surveillance Used by the Royal College of General Practitioners Research and Surveillance Centre and Public Health England.

BackgroundThe Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) and Public Health England (PHE) have successfully worked together on the surveillance of influenza and other infectious diseases for over 50 years, including three previous pandemics. With the emergence of the international outbreak of the coronavirus infection (COVID-19), a UK national approach to containment has been established to test people suspected of exposure to COVID-19. At the same time and separately, the RCGP RSC’s surveillance has been extended to monitor the temporal and geographical distribution of COVID-19 infection in the community as well as assess the effectiveness of the containment strategy.ObjectivesThe aims of this study are to surveil COVID-19 in both asymptomatic populations and ambulatory cases with respiratory infections, ascertain both the rate and pattern of COVID-19 spread, and assess the effectiveness of the containment policy.MethodsThe RCGP RSC, a network of over 500 general practices in England, extract pseudonymized data weekly. This extended surveillance comprises of five components: (1) Recording in medical records of anyone suspected to have or who has been exposed to COVID-19. Computerized medical records suppliers have within a week of request created new codes to support this. (2) Extension of current virological surveillance and testing people with influenza-like illness or lower respiratory tract infections (LRTI)—with the caveat that people suspected to have or who have been exposed to COVID-19 should be referred to the national containment pathway and not seen in primary care. (3) Serology sample collection across all age groups. This will be an extra blood sample taken from people who are attending their general practice for a scheduled blood test. The 100 general practices currently undertaking annual influenza virology surveillance will be involved in the extended virological and serological surveillance. (4) Collecting convalescent serum samples. (5) Data curation. We have the opportunity to escalate the data extraction to twice weekly if needed. Swabs and sera will be analyzed in PHE reference laboratories.ResultsGeneral practice clinical system providers have introduced an emergency new set of clinical codes to support COVID-19 surveillance. Additionally, practices participating in current virology surveillance are now taking samples for COVID-19 surveillance from low-risk patients presenting with LRTIs. Within the first 2 weeks of setup of this surveillance, we have identified 3 cases: 1 through the new coding system, the other 2 through the extended virology sampling.ConclusionsWe have rapidly converted the established national RCGP RSC influenza surveillance system into one that can test the effectiveness of the COVID-19 containment policy. The extended surveillance has already seen the use of new codes with 3 cases reported. Rapid sharing of this protocol should enable scientific critique and shared learning.International Registered Report Identifier (IRRID)DERR1-10.2196/18606

Clinical Ontologies Improve Case Finding of Primary Biliary Cholangitis in UK Primary and Secondary Care.

PBC registries in the UK focus on data from secondary care without clear coordinated contribution from primary care. The Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) receives data from > 500 primary care practices (PCPs). Notably, the Lancet commissioning group is extracting data from the RCGP RSC database to shape UK policy on liver disease. To create a novel ontology to facilitate PBC case finding from primary care provider (PCP) records. RCGP RSC data were collected from participating PCPs in the county of Surrey, UK. PBC diagnostic criteria of the AASLD and EASL guidelines were used to develop 725 data codes to facilitate patient record searches. A scoring system built into the ontology allowed categorization of cases as PBC definite, PBC probable, and PBC unlikely. A total of 218,099 records were searched from participating PCPs. Of these, there were 58 PBC definite, 2317 PBC probable, and 215,724 PBC unlikely patients. There were 32 PBC definite patients who did not match to our regional PBC database and were henceforth included as new-found cases. Two of these cases were not labeled as PBC by the PCP. From the PBC unlikely group, 7/215,724 (0.003%) patients were labeled as PBC in secondary care records; however, none of them were coded as having PBC by their PCPs. Utilization of the UK National RCGP RSC database supported by novel ontology score has successfully helped us identify (i) new cases of PBC not known to local/regional secondary care providers and (ii) de novo PBC cases. There are many PBC probable cases whose data merit further careful evaluation.

How Generalizable Are Cardiovascular Outcome Trials of Sodium-Glucose Co-Transporter-2 Inhibitors? A National Database Study: Study Protocol.

IntroductionSodium-glucose co-transporter-2 (SGLT2) inhibitors are oral antihyperglycemic agents for the treatment of people with type 2 diabetes (T2DM). Two recent cardiovascular outcome trials (CVOTs), the EMPA-REG OUTCOME trial and CANVAS Program, have demonstrated that SGLT2 inhibitors have cardiovascular benefit in high-risk cardiovascular patients. The aim of our study will be to identify the prevalence of patients in an English primary care setting with the equivalent cardiovascular risk profile to those included in each of four SGLT2 inhibitor CVOTs: CANVAS, DECLARE, EMPA-REG, and VERTIS CV.MethodsRoutinely collected primary care data from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network database will be used. We will perform a cross-sectional analysis to calculate the prevalence of people that have equivalent cardiovascular risk to participants included in each of the four above-mentioned SGLT2 inhibitor CVOTs. The demographic and clinical characteristics of the subgroups will also be compared with participants in each trial. The study cohort will include people with T2DM in the RCGP RSC dataset. Subgroups of people will be identified using Read codes that most closely match the inclusion criteria of each trial. Descriptive statistics will be used to report the characteristics of people at high cardiovascular risk and compared against those of people in each CVOT.Planned OutputsFindings from the study will be submitted for publication in a peer-reviewed journal to report the applicability of each SGLT2 inhibitor trial to real-world clinical practice.FundingAstraZeneca UK Limited.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-019-0620-8) contains supplementary material, which is available to authorized users.

Serological surveillance of influenza in an English sentinel network: pilot study protocol

BackgroundRapidly undertaken age-stratified serology studies can produce valuable data about a new emerging infection including background population immunity and seroincidence during an influenza pandemic. Traditionally seroepidemiology studies have used surplus...

Variation in the diagnosis and control of hypertension is not explained by conventional variables: Cross-sectional database study in English general practice.

BackgroundHypertension is a major cause of preventable disability and death globally and affects more than one in four adults in England. Unwarranted variation is variation in access, quality, outcome or value which is unexplained by differences in the condition or patient characteristics and which reduces quality and efficiency. Distinguishing unwarranted from variation due to clinical, organisational or patient factors can be challenging. We carried out this study to explore inter-practice variation in the diagnosis and management of hypertension in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network database, a large, representative surveillance database.Methods and findingWe carried out a cross-sectional study using primary care data extracted from the electronic health records of 1,271,419 adults registered at RCGP RSC general practices on 31st December 2016. Logistic regression was used to indirectly standardise practice-level hypertension prevalence and control against the RCGP RSC population, adjusted for age, gender, ethnicity, deprivation, co-morbidity, NHS region and practice size. Inter-practice variation was demonstrated using funnel plots with 95% and 99.8% control limits. The prevalence of detected hypertension was 18.4% (95% CI 18.4–18.5), n = 234,165. Uncontrolled hypertension was present in 146,553 of 196,052 individuals, 25.2% (25.1–25.4), in whom blood pressure had been recorded in the previous year. Hypertension management varied markedly between practices with a three-fold difference in prevalence, 13.5–38.4%, and a four-fold difference in the proportion of uncontrolled hypertension, 11.8–47.9%. Despite adjustment for sociodemographic and practice characteristics funnel plots demonstrated marked over-dispersion.ConclusionsSubstantial variation in the prevalence of diagnosed hypertension and the management of hypertension was only partially explained by characteristics captured within a routine dataset. The over-dispersion suggests variation is not fully explained by these factors and that context, behaviour and processes of care delivery may contribute to variation. Routine data sources in isolation to not provide sufficient contextual data to diagnose the causes of variation.

Extracting primary care records for prostate cancer patients in the CHHiP multicentre randomised control trial: A healthcare data linkage study

IntroductionThe aim is to investigate the effect of cardiovascular and diabetes comorbidities on radiotherapy-related side-effects in prostate cancer. Previous research suggests that comorbidities increase the risk of side-effects, but some cardiovascular medications may reduce symptoms by protecting against radiation damage. The evidence is inconclusive and mechanisms are not fully understood.
 ObjectiveTo explore whether routine primary care data can supplement clinical trial data in evaluating the impact of comorbidities and prescription medications on patient outcomes.
 ApproachThe CHHiP radiotherapy trial (CRUK/06/16) recruited 3,216 prostate cancer patients from 71 centres in UK, Ireland, Switzerland, and New Zealand between 2002 and 2011. Baseline comorbidity and radiotherapy-related side-effects over time were recorded. This was linked to computerised medical records (CMRs) from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database. RCGP RSC is a network of 192 English general practices with over 2 million patients (2.8% of the population).
 ResultsThe English population of CHHiP patients (N=2811) was used. 120 CMRs were linked, which exceeded the estimation of 79 linked records. However, six CMRs showed no evidence of regular GP care and a further eight patients were not recruited into the CHHiP trial until after they had de-registered from an RCGP RSC practice.
 Information on cardiovascular and diabetes comorbidities was extracted for 106 patients. The mean age was 69±7 years, representative of the CHHiP population. From the CMRs, 23 (22%) patients had diabetes and 47 (44%) had hypertension including 37 (35%) who took angiotensin converting enzyme (ACE) inhibitors (medications lowering blood pressure). In addition, 44 (41%) patients took aspirin, 65 (61%) statins (lowering blood lipids) and 14 (13%) took metformin (lowering blood sugar levels). 
 Conclusion/ImplicationsThe small sample limits statistical analysis. However, a clinical trial was successfully linked to GP data to determine comorbidities and medications of patients. This will serve as a pilot for further research. The advantage of data linkage is that it may provide a mechanism for long-term follow-up of radiotherapy-related side-effects.

Incidence and prevalence of cardiovascular disease in English primary care: a cross-sectional and follow-up study of the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC)

ObjectivesTo describe incidence and prevalence of cardiovascular disease (CVD), its risk factors, medication prescribed to treat CVD and predictors of CVD within a nationally representative dataset.DesignCross-sectional study of adults with...

Incidence of household transmission of acute gastroenteritis (AGE) in a primary care sentinel network (1992–2017): cross-sectional and retrospective cohort study protocol

IntroductionAcute gastroenteritis (AGE) is a highly transmissible condition. Determining characteristics of household transmission will facilitate development of prevention strategies and reduce the burden of this disease.We are carrying out this...

Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors: Comparing Trial and Real World Use (Study Protocol).

BackgroundSodium-glucose co-transporter-2 (SGLT2) inhibitors (gliflozins) are the newest class of medication available to treat type 2 diabetes (T2DM). Recent findings from the first complete cardiovascular safety trial in SGLT2 inhibitors, the Empagliflozin, Cardiovascular Outcomes, and Mortality in type 2 diabetes (EMPA-REG OUTCOMES) trial, demonstrated reduced cardiovascular outcomes in people with high cardiovascular risk. How to apply these findings to clinical practice remains unclear, with questions remaining on who will reap this cardiovascular benefit.AimTo describe the proportion of people in the real world currently treated with SGLT2 inhibitors who meet the inclusion criteria of the EMPA-REG trial and therefore could expect the cardiovascular benefit identified by the trial. Similarly, to describe the proportion of people from the whole T2DM population who could also expect this same benefit.Design and SettingRoutinely collected data from UK primary care in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database will be used. The study population will include all people with T2DM within this database (approximately 60,000). We will perform a cross-sectional investigation to describe the characteristics of people currently using SGTL2 inhibitors compared with the population of the EMPA-REG trail. We will similarly compare the characteristics of the RCGP RSC T2DM cohort with the inclusion criteria of the EMPA-REG trial.MethodPeople with T2DM using a pre-existing verified clinical ontological process will be identified, as will people with prescriptions for SGLT2 inhibitors and other medications using Read coded and other proprietary coding systems. Descriptive statistics will be used to characterise the key clinical characteristics of people with T2DM using SGLT2 inhibitors and to compare these characteristics to people included in EMPA-REG trial; the proportion of people who match the trial criteria will be reported.Planned OutputsPeer review publication reporting the real world lessons for clinical practice.FundingAstraZeneca.

RCGP Research and Surveillance Centre Annual Report 2014-2015: disparities in presentations to primary care.

The Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) comprises over 100 general practices in England, with a population of around 1 million, providing a public health surveillance system for England and data for research. To demonstrate the scope of data with the RCGP Annual Report 2014-2015 (May 2014 to April 2015) by describing disparities in the presentation of six common conditions included in the report. This is a report of respiratory and communicable disease incidence from a primary care sentinel network in England. Incidence rates and demographic profiles are described for common cold, acute otitis media, pneumonia, influenza-like illness, herpes zoster, and scarlet fever. The impact of age, sex, ethnicity, and deprivation on the diagnosis of each condition is explored using a multivariate logistic regression. With the exception of herpes zoster, all conditions followed a seasonal pattern. Apart from pneumonia and scarlet fever, the odds of presenting with any of the selected conditions were greater for females (P<0.001). Older people had a greater probability of a pneumonia diagnosis (≥75 years, odds ratio [OR] 6.37; P<0.001). Common cold and influenza-like illness were more likely in people from ethnic minorities than white people, while the converse was true for acute otitis media and herpes zoster. There were higher odds of acute otitis media and herpes zoster diagnosis among the less deprived (least deprived quintile, OR 1.32 and 1.48, respectively; P<0.001). The RCGP RSC database provides insight into the content and range of GP workload and provides insight into current public health concerns. Further research is needed to explore these disparities in presentation to primary care.