Professor Simon de Lusignan
Academic and research departmentsSection of Clinical Medicine and Ageing.
I am a senior academic GP and Professor of Primary Care and Clinical Informatics; Chair in Health Care Management; and Head of Department of Department of Clinical and Experimental Medicine at University of Surrey. My current post brings together the medically qualified people at the University into a single Department. This department spans from surveillance, diabetes and cardiology; through a cancer research institute, to Medicines and Healthcare products Regulatory Agency (MHRA) approved clinical research facility and a newly approved Clinical Trials Unit (CTU). I also lead a Surrey Health Partners, Primary Care Clinical Academic Group.
My research interests are in disease surveillance, quality improvement, how to measure health outcomes from routine data, and incorporating new technology into clinical practice. I am keen to develop more robust methods of collecting and harnessing real world evidence (RWE). My role includes the Directorship of the Royal College of General Practice (RCGP) Research and Surveillance Centre (RSC); England's primary care flu and infectious disease surveillance system; and leading a Lilly supported European RWE centre conducting research into type 2 diabetes. I am looking for opportunities in translational medicine linking “omics” data to phenotype data, as held in computerised medical records.
My current research group has current project with a value of £5.2 million. I have published more than 200 peer reviewed papers and articles. I have recently completed a large cluster randomised trial (QICKD trial - Kidney Int. 2013;84(3):609-20; Heart 2014 Dec;100(23):1837-43); conducted evaluations based on linked hospital, clinic and practice data (Behav Res Ther. 2013;51(7):377-85); and also the world's largest series of consultation videos (J Am Med Inform Assoc. 2013 Jun;20(e1):e67-75). My research focuses on how routinely collected data and other RWE can be used for quality improvement, improving health outcomes, and how IT is best used at the point of care. I am increasingly exploring how to work with linked datasets and exploring the interaction between factors such as physical and mental health, acute infection and chronic disease. My quality improvement work has been in: cardiovascular disease, chronic kidney disease, diabetes, mental health, and vaccine preventable disease. I have led the development of on-line information sources for primary care (BMJ. 1999;319(7223):1476-9) but latterly focussed more on the evaluation of how these and electronic patient record (EPR) systems might best be incorporated into clinical practice. I have been active in developing metrics for improving the quality of management of kidney disease, diabetes and mental health. I have introduced agile methods, used in the software industry, to my research group. We start each day with a stand-up meeting call a scrum, and end the day with an email update, this helps minimise unnecessary communication (especially by email) keeps focus and highlights where people are stuck, so called “blockers.”
I am trained as an educator and have developed innovative new courses including the UK's first full time undergraduate informatics degree; I also have a long experience of supervising undergraduate and post graduate students; and working with them to produce high quality outputs (e.g. Cochrane Database Syst Rev. 2014 Jul 12;7:CD010342). At St. George's I was Head of General Practice and Primary Care, a role which involved supervision of an academic team, extensive curriculum development, and a network of nearly 300 practices. I have recently been offered a major consultancy role to establish a medical university in Saudi Arabia.
My roles as the Director of the RCGP RSC includes producing weekly reports on disease prevalence, and partnership in an extensive range of research with Public Health England; and leadership of a work packages in a range of European research projects looking at vaccine preventable disease, uptake, benefits and risks.
I have been a partner in my practice for nearly 30 years and have been active in the local health community. My practice has always been innovative. We were first wave Fundholders (a scheme where practice took partial financial responsibility for patient care), I have been PEC (Professional Executive Committee) chair - chair of the senior medical committee in the local health community; my practice was one of six to form the country's first pilot ICO (Integrated Care Organisation) and until March 2011 deputy chair of the Guildford Practice-Based Commissioning group. I am currently practice representative on the Clinical Commissioning Group Council, and convene the locality research group - the Surrey Health Partners primary care Clinical Academic group.
The Clinical Informatics research group I lead has raised over £5 million in funding and published over 200 peer reviewed papers and articles. My quality improvement work has been in: cardiovascular disease, chronic kidney disease, diabetes, mental health dermatology, and osteoporosis. I have led the development of on-line information sources for primary care but latterly focussed more on the evaluation of how these and electronic patient record (EPR) systems might best be incorporated into clinical practice. I have been active in developing metrics for improving the quality of management of chronic kidney disease, diabetes and mental health.
I have important collaborations within the Faculty, wider University, regionally, nationally and internationally.
My major links across the University are with the Faculty of Health and Medical Sciences - Prof David Lewis (vaccine research and PI for the BioVacSafe consortium); Professor Paul Krause (Computing); Professor Chris Fife-Schaw (Psychology, and PI for the GHT2000 exercise to treat hypertension trial.
We have a large number of regional collaborations. These include AT Medics with whom we have a Knowledge Transfer Partnership (KTP) and a joint research group SATIRE (Surrey AT Medics Research and Enterprise). We have strong collaborations with Imperial where we are collaborating in the LOLIPOP cohort, SABRE cohort, and diabetes data quality in the BIOBANK project. I also have a small role with the PCRN southeast and have set up a research group with the local NHS: Guildford and Waverley Clinical Commissioning Group as well as being a member of diabetes, primary care and older persons clinical academic groups. I also have links and collaboration with the hepatologists at Frimley Park Hospital.
I retain research links with St. George's, where I hold an honorary chair. I also hold an honorary chair at University of Sussex, at Brighton and Sussex Medical School.
I have my strongest national collaboration with the Royal College of General Practitioners (RCGP). I am their representative on the National General Practice Extraction Service (GPES) Independent Advisory Group (IAG) - the group that independently reviews the need to extract routine data for health service management. I am also the Medical Director of the RCGP Research and Surveillance Centre The RSC is a key national surveillance centre for spotting outbreaks of disease, particularly flu and flu-like illnesses.
My current research involves collaboration with key international companies in health care companies. For Glaxo Smith Kline we are conducting a feasibility study of surveillance of possible adverse events after the season of flu vaccine using routinely recorded data . University of Surrey has partnered up with El Lilly to create a Real World Centre at which we perform a range of studies aiming to improve outcome for people with Type 2 Diabetes.
I also have international collaborations are with colleagues in Australia - Professor Teng Siaw-Liaw, and A/Professor Chris Pearce; Canada A/Professor Amanda Terry; and with colleagues in Sao Paulo University in Brazil.
I am also the Chair of the European Federation for Medical Informatics (EFMI) and International Medical Informatics Association (IMIA) Primary Health Care Informatics Working Group chairs.
I have a strategic role as head of department to develop our teaching portfolio. My main teaching duties are supervision of students on a Health Services Research Module which will be rolled across the Faculty of Health and Medical Science as well as offering support to two short courses (SISS and SWiSS - The Surrey Informatics Summer School and our Surrey Winter Statistical School).
Academic F2 (Foundation programme second year doctors)
I supervise academic F2 doctors in their second year or qualification while they undertake a four month academic attachment. Nearly all of these doctors have produced high grade peer review publications during these attachments. We are hopeful that this post might expand in future.
Doctoral students - MD and PhD
I encourage applications, visits to the Department and attendance on our short courses, from ambitious students looking to work in our domain.
Knowledge Transfer Fellow
I jointly supervise a Knowledge Transfer Fellow, who is part of a KTP with AT Medics - a leading supplier of primary health care services in London.
Head of Department of Clinical and Experimental Medicine
We have a strategy to grow our Department. We are looking to attract the highest quality researchers and teachers to come and work with our excellent team here at Surrey. In research we have an exciting blend of research, but are looking to grow to the critical mass where we can attract programme, unit and centre funding. In enterprise we are looking to form alliances with leading providers of health care and organisations that support them. Within the Section of Clinical Medicine and Ageing, we run three short courses - SISS - A Summer School in Informatics (a 5 day course in July), SWiSS - Surrey Winter Statistical School, and Demand and Capacity Planning for Elective Care - A full time 3 day non-residential short course for health care managers and commissioners wanting to create and implement resilient demand and capacity plans.
Academic Health Sciences Network (AHSN)
I support the AHSN and two of the Clinical Academic Groups (CAG) within it (Diabetes, Primary Care and Older People).
University health and medical strategy committees
I will continue to represent the Department and where the Dean sees appropriate the Faculty on University health and medical strategy committees.
Clinical Informatics and Health Outcomes Research Group
I will continue to lead this group in collaboration.
- Fellow of Royal College of General Practitioners - FRCGP
- Fellow of the British Computer Society - Chartered Information Technology Professional - FBCS CITP
- Fellow of the Higher Education Academy - FHEA
- Member of the Society of Academic Primary Care
- Visiting Professor - St. George's - University of London
- Visiting Professor - Sussex University / Brighton and Sussex Medical School
- Chair Primary Care Working Group and UK representative to European Federation for Medical Informatics (EFMI)
- Chair Primary Health Care Working Group International Medical Informatics Association (IMIA)
- General Practitioner (Partner) Prof Simon de Lusignan & Partners, Woodbridge Hill Surgery, Guildford
Contact the press team
Phone: +44 (0)1483 684380 / 688914 / 684378
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Senate House, University of Surrey
Guildford, Surrey GU2 7XH
number of verbal and non-verbal behaviours have been identified as important to establish a good
relationship with the patient. However, the use of the computer detracts the doctor's attention
away from the patient, compromising these essential elements of the consultation. Current
methods to assess the consultation and the influence of the computer on them are time consuming
and subjective. If it were possible to measure these quantitatively, it could provide the basis for the
first truly objective way of studying the influence of the computer on the consultation.
The aim was to assess whether pattern recognition software could be used to measure the
influence and pattern of computer use in the consultation. If this proved possible it would provide,
for the first time, an objective quantitative measure of computer use and a measure of the attention
and responsiveness of the general practitioner towards the patient.
Methods: A feasibility study using pattern recognition software to analyse a consultation was
conducted. A web camera, linked to a data-gathering node was used to film a simulated consultation
in a standard office. Members of the research team enacted the role of the doctor and the patient,
using pattern recognition software to try and capture patient-centred, non-verbal behaviour. As
this was a feasibility study detailed results of the analysis are not presented.
Results: It was revealed that pattern recognition software could be used to analyse certain aspects
of a simulated consultation. For example, trigger lines enabled the number of times the clinician's
hand covered the keyboard to be counted and wrapping recorded the number of times the clinician
nodded his head. It was also possible to measure time sequences and whether the movement was
brief or lingering.
Conclusion: Pattern recognition software enables movements associated with patientcentredness
to be recorded. Pattern recognition software has the potential to provide an objective,
quantitative measure of the influence of the computer on the consultation.
Physician associates [PAs] (also known as
physician assistants) are new to the NHS
and there is little evidence concerning their
contribution in general practice. Aim
This study aimed to compare outcomes and
costs of same-day requested consultations by
PAs with those of GPs. Design and setting
An observational study of 2086 patient records
presenting at same-day appointments in 12
general practices in England. Method
PA consultations were compared with those
of GPs. Primary outcome was re-consultation
within 14 days for the same or linked problem.
Secondary outcomes were processes of care. Results
There were no significant differences in
the rates of re-consultation (rate ratio 1.24,
95% confidence interval [CI] = 0.86 to 1.79,
P = 0.25). There were no differences in rates
of diagnostic tests ordered (1.08, 95% CI = 0.89
to 1.30, P = 0.44), referrals (0.95, 95% CI = 0.63
to 1.43, P = 0.80), prescriptions issued (1.16,
95% CI = 0.87 to 1.53, P = 0.31), or patient
satisfaction (1.00, 95% CI = 0.42 to 2.36,
P = 0.99). Records of initial consultations of
79.2% (n = 145) of PAs and 48.3% (n = 99) of
GPs were judged appropriate by independent
GPs (P consultation was 5.8 minutes longer than the
GP consultation (95% CI = 2.46 to 7.1; P cost per consultation was GBP £6.22, (US$
10.15) lower (95% CI = ?7.61 to ?2.46, P The processes and outcomes of PA and GP
consultations for same-day appointment
patients are similar at a lower consultation
cost. PAs offer a potentially acceptable and
efficient addition to the general practice
(IAPT) comprised the study of all people identified as having common mental health problems (CMHP), those
referred to the IAPT service, and a sample of attenders studied in-depth. Information technology makes it feasible
to link practice, hospital and IAPT clinic data to evaluate the representativeness of these samples. However,
researchers do not have permission to browse and link these data without the patients? consent.
Objective: To demonstrate the use of a mixed deterministic-probabilistic method of secure and private record
linkage (SAPREL) - to describe selection bias in subjects chosen for in-depth evaluation.
Method: We extracted, pseudonymised and used fuzzy logic to link multiple health records without the researcher
knowing the patient?s identity. The method can be characterised as a three party protocol mainly using
deterministic algorithms with dynamic linking strategies; though incorporating some elements of probabilistic
linkage. Within the data providers? safe haven we extracted: Demographic data, hospital utilisation and IAPT clinic
data; converted post code to index of multiple deprivation (IMD); and identified people with CMHP. We contrasted
the age, gender, ethnicity and IMD for the in-depth evaluation sample with people referred to IAPT, use hospital
services, and the population as a whole.
Results: The in IAPT-in-depth group had a mean age of 43.1 years; CI: 41.0 - 45.2 (n = 166); the IAPT-referred 40.2
years; CI: 39.4 - 40.9 (n = 1118); and those with CMHP 43.6 years SEM 0.15. (n = 12210). Whilst around 67% of
those with a CMHP were women, compared to 70% of those referred to IAPT, and 75% of those subject to indepth
evaluation (Chi square p 38.9; (n = 166); of those referred to IAPT 38.7; CI: 37.9 - 39.6; (n = 1117); and of people with CMHP 37.6; CI 37.3-
37.9; (n = 12143).
Conclusions: The sample studied in-depth were older, more likely female, and less deprived than people with
CMHP, and fewer had recorded ethnic minority status. Anonymous linkage using SAPREL provides insight into the
representativeness of a study population and possible adjustment for selection bias.
Serum phosphate is a known risk factor for cardiovascular events and mortality in people with chronic kidney disease (CKD), however data on the association of these outcomes with serum phosphate in the general population are scarce. We investigate this relationship in people with and without CKD in a large community-based population.
Three groups from an adult cohort of the Quality Improvement in Chronic Kidney Disease (QICKD) cluster randomised trial (ISRCTN56023731) were followed over a period of 2.5 years: people with normal renal function (N = 24,184), people with CKD stages 1?2 (N = 20,356), and people with CKD stages 3?5 (N = 13,292). We used a multilevel logistic regression model to determine the association between serum phosphate, in these groups, and a composite outcome of all-cause mortality, cardiovascular events, and advanced coronary artery disease. We adjusted for known cardiovascular risk factors.
Higher phosphate levels were found to correlate with increased cardiovascular risk. In people with normal renal function and CKD stages 1?2, Phosphate levels between 1.25 and 1.50 mmol/l were associated with increased cardiovascular events; odds ratio (OR) 1.36 (95% CI 1.06?1.74; p = 0.016) in people with normal renal function and OR 1.40 (95% CI 1.09?1.81; p = 0.010) in people with CKD stages 1?2. Hypophosphatemia (1.50 mmol/l) was associated with increased cardiovascular risk; OR 2.34 (95% CI 1.64?3.32; p Conclusions
Serum phosphate is associated with cardiovascular events in people with and without CKD. Further research is required to determine the mechanisms underlying these associations.
new class of oral diabetes medication. Prescribing of these agents was
initially limited to secondary care but is now moving into primary
care. We analyse the current use of this drug class in primary care.
The National Institute for Health and Care
Excellence (NICE) recommends postpartum and
annual monitoring for diabetes for females who
have had a diagnosis of gestational diabetes
To describe the current state of follow-up after
GDM in primary care, in England.
Design and setting
A retrospective cohort study in 127 primary
care practices. The total population analysed
comprised 473 772 females, of whom 2016 had
a diagnosis of GDM.
Two subgroups of females were analysed
using electronic general practice records.
In the first group of females (
= 788) the
quality of postpartum follow-up was assessed
during a 6-month period. The quality of long-
term annual follow-up was assessed in a
second group of females (
= 718), over a
5-year period. The two outcome measures
were blood glucose testing performed within
months postpartum (first group) and blood
glucose testing performed annually (second
Postpartum follow-up was performed in 146
(18.5%) females within 6 months of delivery.
Annual rates of long-term follow-up stayed
consistently around 20% a year. Publication
Diabetes in Pregnancy
in 2008, had no effect on long-term screening
rates. Substantial regional differences were
identified among rates of follow-up.
Monitoring of females after GDM is
markedly suboptimal despite current
Sir Edward Waine, regius professor of medicine in Glasgow, who invented Waine's thyroid index, an early, pre-computer, decision support system, used to teach about ?la maladie du petit papier.? This described the patient who, somewhat nervously, took a little bit of paper out of his jacket pocket towards the end of the consultation and used this paper to remind him of the questions that he knew he was bound to forget in the stress of the consultation. Many clinicians have now found that le maladie du petit papier is now but a fond memory as they face daily ?la maladie du grand print-out,? an altogether more daunting challenge. The world wide web has blown away the walls and doors of medical libraries, which once shielded medical knowledge from the public gaze. Members of the public can now have access to almost all the information that professionals have.
metabolism in diabetes is complicated and yet to be fully
elucidated. Here we aim to characterise the relationship between
glycaemic control and serum triglyceride levels in a population
with Type 2 diabetes
This paper sets to fill that gap by defining RWE as the output from a rigorous research process which: (1) includes a clear a priori statement of a hypothesis to be tested or research question to be answered; (2) defines the data sources that will be used and critically appraises their strengths and weaknesses; and (3) applies appropriate methods, including advanced analytics. These elements should be set
out in advance of the study commencing, ideally in a published protocol.
The strengths of RWE studies are that they are more inclusive than RCTs and can enable an evidence base to be developed around real-world effectiveness and to start to address the complications of managing other real-world problems such as multimorbidity. Computerised medical record systems and big data provide a rich
source of data for RWE studies.
However, guidance is needed to help assess the rigour of RWE studies so that the strength of recommendations based on their output can be determined. Additionally, RWE advanced analytics methods need better categorisation and validation. We predict that the core role of RCTs will shift towards assessing safety and achieving regulatory compliance. RWE studies, notwithstanding their limitations, may become established as the best vehicle to assess efficacy.
To inform this debate, we need to be clear about what we mean by e-Health and the evidence base, their origins and definitions (Boxes 1 and 2).
clinical data recorded as part of routine care. A knowledge audit identifies from within this mass of
information the knowledge requirements of a professional group or organization, enabling implementation
of an appropriately tailored knowledge-management strategy. The objective of the study is to
describe perceived knowledge gaps and recommend an appropriate knowledge-management strategy for
primary care. The sample comprised 18 senior managers of Primary Care Trusts: the Chairman, Chief
Executive Officer, or Research and Development Lead. A series of interviews were recorded verbatim,
transcribed and analysed. Knowledge requirements were broad, suggesting that a broadly based
knowledge-management strategy is needed in primary care. The biggest gap in current knowledge
identified is how to perform needs assessment and quality improvement using aggregated routinely
collected, general practice computer data.
We performed a retrospective cohort analysis to determine if the presence of sensory neuropathy can be used as a predictor for increased risk of death. We used routinely recorded electronic data from 126 primary care centres across England, who participated in the Quality Improvement in Chronic Kidney Disease (QICKD) trial to follow a cohort of people with diabetes (N=35,502) over 30 months. The presence of sensory neuropathy was defined as present or absent based on routine 10g monofilament testing during 30 months prior to the observation period. The outcome measure was all-cause mortality. Known risk factors (age, gender, smoking status, co-morbidities, and HbA1c) were adjusted for using a multilevel logistic regression model.
Monofilament testing was performed in 18,748 (52.2%) people during the baseline period. Abnormal sensation was identified in 1,548 (9.0%). Abnormal sensation was associated with an increased risk of mortality during the 30 month follow-up period: odds ratio 1.70 (95% confidence interval 1.41-2.06; p Sensory neuropathy is an important predictor of mortality in people with diabetes; and the monofilament test may have utility in primary care. People with abnormal sensation should be targeted for aggressive diabetes management.
anonymous linkage of practice, hospital and
clinic data using Secure and Private Record
Linkage (SAPREL): case study from the evaluation
of the Improved Access to Psychological Therapy
(IAPT) service, BMC Medical Informatics and Decision Making 11
avoidable hospital admissions identified through an Academic Health and Social
Care Network, BMC Health Services Research 12 BioMed Central
Results: Most evidence was descriptive with an almost complete absence of empirical research and important gaps in the evidence-base. We found some use of ontologies and semantic integration methods for community support of the medical home and for care in the community. Ubiquitous information technology (IT) and other IT tools were deployed to support self-management support, use of shared registries, health behavioural models and knowledge discovery tools to improve delivery system design. Data quality issues restricted the use of clinical data; however there was an increased use of interoperable data and health system integration. Conclusions: Ontologies and semantic integration methods are emergent with limited evidence-base for their implementation. However, they have the potential to integrate the disparate com- munity wide data sources to provide the information necessary for effective chronic disease management.
Objective: To assess the factors that may affect the provision of online patient access to their EHR and transactional services, and the impact of such access on the quality and safety of health care.
Method: Two reviewers independently searched 11 international databases during the period 1999-2012. A range of papers including descriptive studies using qualitative or quantitative methods, hypothesis-testing studies and systematic reviews were included. A detailed eligibility criterion will be used to shape study inclusion. A team of experts will review these papers for eligibility, extract data using a customised extraction form and use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument to determine the quality of the evidence and the strengths of any recommendation. Data will then be descriptively summarised and thematically synthesised. Where feasible, we will perform a quantitative meta-analysis. Prospero (International Prospective Register of Systematic Reviews) registration number: crd42012003091.
The use of glucagon-like peptide-1 (GLP-1)
agonists in type 2 diabetes is increasing.
We present a description of their current
use and prescribing trends in UK primary
care and compare the characteristics of
people prescribed GLP-1 agonists with
phase 3 trial populations.
Asthma is an important condition associated with a substantial mortality and morbidity. However, there are difficulties in determining who has the condition, making both its incidence and prevalence uncertain.
Objective: To demonstrate an approach for modelling complexity in health using asthma prevalence and incidence as an exemplar.
Method: The four steps in our process are:
1. Drawing a rich picture, following Checkland?s soft systems methodology;
2. Constructing data flow diagrams (DFDs);
3. Creating Unified Modelling Language (UML) use case diagrams to describe the interaction of the key actors with the system;
4. Activity diagrams, either UML activity diagram or business process modelling notation diagram.
Results: Our rich picture flagged the complexity of factors that might impact on asthma diagnosis. There was consensus that the principle issue was that there were undiagnosed and misdiagnosed cases as well as correctly diagnosed. Genetic predisposition to atopy; exposure to environmental triggers; impact of respiratory health on earnings or ability to attend education or participate in sport, charities, pressure groups and the pharmaceutical industry all increased the likelihood of a diagnosis of asthma. Stigma and some factors within the health system diminished the likelihood of a diagnosis. The DFDs and other elements focused on better case finding.
Conclusions: This approach flagged the factors that might impact on the reported prevalence or incidence of asthma. The models suggested that applying selection criteria may improve the specificity of new or confirmed diagnosis.
Diabetes and infection: assessing the association with glycaemic control in population-based studies
The Lancet Diabetes & Endocrinology, Volume 4, Issue 2, February 2016, Pages 148-158
Aim To assess the impact of providing patients with access to their general practice electronic health records (EHR) and other EHR-linked online services on the provision, quality, and safety of health care.
Design and setting A systematic review was conducted that focused on all studies about online record access and transactional services in primary care.
Method Data sources included MEDLINE, Embase, CINAHL, Cochrane Library, EPOC, DARE, King?s Fund, Nuffield Health, PsycINFO, OpenGrey (1999?2012). The literature was independently screened against detailed inclusion and exclusion criteria; independent dual data extraction was conducted, the risk of bias (RoB) assessed, and a narrative synthesis of the evidence conducted.
Results A total of 176 studies were identified, 17 of which were randomised controlled trials, cohort, or cluster studies. Patients reported improved satisfaction with online access and services compared with standard provision, improved self-care, and better communication and engagement with clinicians. Safety improvements were patient-led through identifying medication errors and facilitating more use of preventive services. Provision of online record access and services resulted in a moderate increase of e-mail, no change on telephone contact, but there were variable effects on face-to-face contact. However, other tasks were necessary to sustain these services, which impacted on clinician time. There were no reports of harm or breaches in privacy.
Conclusion While the RoB scores suggest many of the studies were of low quality, patients using online services reported increased convenience and satisfaction. These services positively impacted on patient safety, although there were variations of record access and use by specific ethnic and socioeconomic groups. Professional concerns about privacy were unrealised and those about workload were only partly so.
significant challenges to the timely delivery of health research.
Whilst the fundamental drivers to ensure that data access is
ethical and satisfies privacy requirements are similar, they are
often dealt with in varying ways by different approval processes.
Objective: To achieve a consensus across an international panel
of health care and informatics professionals on an integrated set
of privacy and ethics principles that could accelerate health data
access in data-driven health research projects.
Method: A three-round consensus development process was
used. In round one, we developed a baseline framework for
privacy, ethics, and data access based on a review of existing
literature in the health, informatics, and policy domains. This
was further developed using a two-round Delphi consensus
building process involving 20 experts who were members of
the International Medical Informatics Association (IMIA) and
European Federation of Medical Informatics (EFMI) Primary
Health Care Informatics Working Groups. To achieve consensus
we required an extended Delphi process.
Results: The first round involved feedback on and development
of the baseline framework. This consisted of four components:
(1) ethical principles, (2) ethical guidance questions, (3) privacy
and data access principles, and (4) privacy and data access
guidance questions. Round two developed consensus in key areas
of the revised framework, allowing the building of a newly, more
detailed and descriptive framework. In the final round panel experts
expressed their opinions, either as agreements or disagreements,
on the ethics and privacy statements of the framework finding some
of the previous round disagreements to be surprising in view of
established ethical principles.
Conclusion: This study develops a framework for an integrated approach
to ethics and privacy. Privacy breech risk should not be considered
in isolation but instead balanced by potential ethical benefit.
performance, user acceptance and safety were assessed for monitoring in the patient?s home. The
study included 20 patients: six with chronic obstructive pulmonary disease, six with chronic heart
failure, seven with atrial fibrillation and palpitations, and one with a snoring problem. The system
recorded the heart rate and respiratory rate, blood pressure, electrocardiogram and body temperature.
The results were transmitted automatically to a central monitoring station. The accuracy of the
measurements was checked by a comparison system and also by conventional measurements
performed by a nurse. The system was acceptable to patients and functioned satisfactorily in the home.
An important facet of home telemonitoring may turn out to be its greater reliability in collecting
community: a service evaluation of community
matron?s case-finding strategies, Family Practice 28 (4)
affected by obesity, and are at risk of developing type 2 diabetes,
cardiovascular disease and related metabolic and inflammatory
. Although the mechanisms linking adiposity to
associated clinical conditions are poorly understood, recent studies
suggest that adiposity may influence DNA methylation3?6, a key
regulator of gene expression and molecular phenotype7
. Here we
use epigenome-wide association to show that body mass index
(BMI; a key measure of adiposity) is associated with widespread
changes in DNA methylation (187 genetic loci with P ,
to 6.0×10?46; n=10,261 samples). Genetic
association analyses demonstrate that the alterations in DNA
methylation are predominantly the consequence of adiposity,
rather than the cause. We find that methylation loci are enriched
for functional genomic features in multiple tissues (P show that sentinel methylation markers identify gene expression
signatures at 38 loci (P , range P = 5.5 × 10?6
6.1×10?35, n=1,785 samples). The methylation loci identify genes
involved in lipid and lipoprotein metabolism, substrate transport
and inflammatory pathways. Finally, we show that the disturbances
in DNA methylation predict future development of type 2 diabetes
(relative risk per 1 standard deviation increase in methylation risk
score: 2.3 (2.07?2.56); P=1.1×10?54). Our results provide new
insights into the biologic pathways influenced by adiposity, and may
enable development of new strategies for prediction and prevention
of type 2 diabetes and other adverse clinical consequences of obesity
physician assistants) are new to the NHS
and there is little evidence concerning their
contribution in general practice.
This study aimed to compare outcomes and
costs of same-day requested consultations by
PAs with those of GPs.
Diabetes confers a two times excess risk of cardiovascular disease, yet predicting individual risk remains challenging. The effect of total microvascular disease burden on cardiovascular disease risk among individuals with diabetes is unknown.
A population-based cohort of patients with type 2 diabetes from the UK Clinical Practice Research Datalink was studied (n=49?027). We used multivariable Cox models to estimate hazard ratios (HRs) for the primary outcome (the time to first major cardiovascular event, which was a composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischaemic stroke) associated with cumulative burden of retinopathy, nephropathy, and peripheral neuropathy among individuals with no history of cardiovascular disease at baseline.Findings
During a median follow-up of 5·5 years, 2822 (5·8%) individuals experienced a primary outcome. After adjustment for established risk factors, significant associations were observed for the primary outcome individually for retinopathy (HR 1·39, 95% CI 1·09?1·76), peripheral neuropathy (1·40, 1·19?1·66), and nephropathy (1·35, 1·15?1·58). For individuals with one, two, or three microvascular disease states versus none, the multivariable-adjusted HRs for the primary outcome were 1·32 (95% CI 1·16?1·50), 1·62 (1·42?1·85), and 1·99 (1·70?2·34), respectively. For the primary outcome, measures of risk discrimination showed significant improvement when microvascular disease burden was added to models. In the overall cohort, the net reclassification index for USA and UK guideline risk strata were 0·036 (95% CI 0·017?0·055, p
The cumulative burden of microvascular disease significantly affects the risk of future cardiovascular disease among individuals with type 2 diabetes. Given the prevalence of diabetes globally, further work to understand the mechanisms behind this association and strategies to mitigate this excess risk are warranted.
repeat prescriptions and booking appointments, enables patients to personalize their access
to care. However, online access creates opportunities and challenges for both health
professionals and their patients, in practices and in research. The challenges for practice are
the impact of online services on workload and the quality and safety of health care. Health
professionals are concerned about the impact on workload, especially from email or other
online enquiry systems, as well as risks to privacy. Patients report how online access
provides a convenient means through which to access their health provider and may offer
greater satisfaction if they get a timely response from a clinician. Online access and services
may also result in unforeseen consequences and may change the nature of the patient-clinician
interaction. Research challenges include: (1) Ensuring privacy, including how to control
inappropriate carer and guardian access to medical records; (2) Whether online access to
records improves patient safety and health outcomes; (3) Whether record access increases
disparities across social classes and between genders; and (4) Improving efficiency. The
challenges for practice are: (1) How to incorporate online access into clinical workflow; (2)
The need for a business model to fund the additional time taken. Creating a sustainable business model for a safe, private, informative, more equitable online service is needed if
online access to records is to be provided outside of pay-for-service systems.
health records (EHR) have been available
for research in the UK for at least two
decades. The time has come for a rethink
in how we coordinate the sharing of data
for research, in a way that provides clear
benefits for patients and practices as well
as researchers. Up until now, sharing data
for research provides long-term benefits
for the public, patients, and practitioners
as a result of the implementation of these
research findings. While these benefits are
clearly in the public interest, our current
approach provides few immediate benefits.
Therapies (IAPT) is a new programme designed to
reduce disease burden to the individual and economic
burden to the society of common mental health
problems (CMHP). This is the first study to look at the
impact of IAPT on health service utilisation and sickness
absence using routine data.
Method The authors used pseudonymised secure and
privately linked (SAPREL) routinely collected primary,
secondary care and clinic computer data from two pilot
localities. The authors explored antidepressant
prescribing, accident and emergency and outpatients
attendances, inpatient stays, bed days, and sick
certification. The authors compared the registered
population with those with CMHP. The authors then
made a 6 months before and after comparison of people
referred to IAPT with ageesex and practice-matched
Results People with CMHP used more health resources
than those without CMHP: more prescriptions of
antidepressants 5.25 (95% CI 5.38 to 5.13), inpatient
episodes 4.89 (95% CI 5.0 to 4.79), occupied bed days
1.25 (95% CI 0.95 to 1.55), outpatient 1.5 (95% CI 1.40
to 1.63) and emergency department attendances 0.34
(95% CI 0.31 to 0.37), and medical certificates 0.29
(95% CI 0.26 to 0.32). Comparison of service utilisation
6 months before and after referral to IAPT was
associated with reduced use of emergency department
attendances (mean difference: 0.12 (95% CI 0.06 to
0.19, p of antidepressants increased mean difference 0.15
(95% CI 0.02 0.29, p¼0.028).
Conclusions People with CMHP use more healthcare
resources. Referral to the IAPT programme is associated
with a subsequent reduction in emergency department
attendances, sickness certification and improved
adherence to drug treatment.
We conducted a cohort study using prospectively collected data on 856 SLNBs analysed using OSNA, from patients with cT1-3 clinically node-negative invasive breast cancer. ALND was performed for 289 positive SLNBs.
NSLN metastases were identified in 73 (25.3%) ALNDs. Significant factors for NSLN involvement on multivariate analysis were: SLNB macrometastases (cytokeratin-19 mRNA count >5000 copies/¼l) (adj.OR = 3.01; 95% CI, 1.61?5.66; p = 0.0006), multiple all positive vs. multiple incomplete positive SLNB (adj.OR = 2.92; 95% CI, 1.38?6.19; p = 0.0050), and undergoing mastectomy (adj.OR = 1.89; 95% CI, 1.00?3.55; p = 0.0486). Amongst multiple incomplete positive SLNBs, an 8.8% NSLN risk was identified when only micrometastases were present.
Extent of sentinel lymph node positivity measured using OSNA predicts NSLN metastasis risk, aiding decisions surrounding axillary treatment.
We performed a systematic review of the accuracy of patient self-report of stroke to inform approaches to ascertaining and confirming stroke cases in large prospective studies.
We sought studies comparing patient self-report against a reference standard for stroke. We extracted data on survey method(s), response rates, participant characteristics, the reference standard used, and the positive predictive value (PPV) of self-report. Where possible
we also calculated sensitivity, specificity, negative predictive value (NPV), and stroke prevalence. Study-level risk of bias was assessed using the Quality Assessment of Diagnostic Studies tool (QUADAS-2).
From >1500 identified articles, we included 17 studies. Most asked patients to report a lifetime history of stroke but a few limited recall time to 5 years. Some included questions for transient ischaemic attack (TIA) or stroke synonyms. No study was free of risk of bias in the
QUADAS-2 assessment, the most frequent causes of bias being incomplete reference standard data, absence of blinding of adjudicators to self-report status, and participant response rates ( (10 studies), specificity from 96?99.6% (10 studies), and NPV from 88.2?99.9% (10 studies). PPV increased with stroke prevalence as expected. Among six studies with available relevant data, if confirmed TIAs were considered to be true rather than false positive strokes, PPV of self-report was >75% in all but one study. It was not possible to assess the
influence of recall time or of the question(s) asked on PPV or sensitivity. Conclusions
Characteristics of the study population strongly influence self-report accuracy. In population based studies with low stroke prevalence, a large proportion of self-reported strokes may be false positives. Self-report is therefore unlikely to be helpful for identifying cases without subsequent confirmation, but may be useful for case ascertainment in combination
with other data sources.
Patients receiving cancer treatment often have one or more co-morbid conditions that are treated pharmacologically. Co-morbidities are recorded in clinical trials usually only at baseline. However, co-morbidities evolve and new ones emerge during cancer treatment. The interaction between multi-morbidity and cancer recovery is significant but poorly understood.
To investigate the effect of co-morbidities (e.g. cardiovascular and diabetes) and medications (e.g. statins, antihypertensives, metformin) on radiotherapy-related toxicity and long-term symptoms in order to identify potential risk factors. The possible protective effect of medications such as statins or antihypertensives in reducing radiotherapy-related toxicity will also be explored.
Two datasets will be linked. 1) CHHiP (Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer) randomised control trial. CHHiP contains pelvic symptoms and radiation-related toxicity reported by patients and clinicians. 2) GP (General Practice) data from RCGP RSC (Royal College of General Practitioners Research and Surveillance Centre). The GP records of CHHiP patients will be extracted, including cardiovascular co-morbidities, diabetes and prescription medications. Statistical analysis of the combined dataset will be performed in order to investigate the effect.
Linking two sources of healthcare data is an exciting area of big healthcare data research. With limited data in clinical trials (not all clinical trials collect information on co-morbidities or medications) and limited lengths of follow-up, linking different sources of information is increasingly needed to investigate long-term outcomes. With increasing pressures to collect detailed information in clinical trials (e.g. co-morbidities, medications), linkage to routinely collected data offers the potential to support efficient conduct of clinical trials.
Objective: We aimed to investigate whether vitamin D2 or vitamin D3 fortified in juice or food, at a relatively low dose of 15 ¼g/d, was effective in increasing serum total 25(OH)D and to compare their respective efficacy in South Asian and white European women over the winter months within the setting of a large randomized controlled trial.
Design: A randomized, double-blind, placebo-controlled food-fortification trial was conducted in healthy South Asian and white European women aged 20?64 y (n = 335; Surrey, United Kingdom) who consumed placebo, juice supplemented with 15 ¼g vitamin D2, biscuit supplemented with 15 ¼g vitamin D2, juice supplemented with 15 ¼g vitamin D3, or biscuit supplemented with 15 ¼g vitamin D3 daily for 12 wk. Serum 25(OH)D was measured by liquid chromatography?tandem mass spectrometry at baseline and at weeks 6 and 12 of the study.
Results: Postintervention in the 2 ethnic groups combined, both the vitamin D3 biscuit and the vitamin D3 juice groups showed a significantly greater absolute incremental change () in total 25(OH)D when compared with the vitamin D2 biscuit group [ (95% CI): 15.3 nmol/L (7.4, 23.3 nmol/L) (P
Conclusions: With the use of a daily dose of vitamin D relevant to public health recommendations (15 ¼g) and in vehicles relevant to food-fortification strategies, vitamin D3 was more effective than vitamin D2 in increasing serum 25(OH)D in the wintertime. Vitamin D3 may therefore be a preferential form to optimize vitamin D status within the general population. This trial was registered at www.controlled-trials.com as ISRCTN23421591.
Ethnicity recording within primary care computerised medical record (CMR) systems is suboptimal, exacerbated by tangled taxonomies within current coding systems.
To develop a method for extending ethnicity identification using routinely collected data.
We used an ontological method to maximise the reliability and prevalence of ethnicity information in the Royal College of General Practitioner?s Research and Surveillance database. Clinical codes were either directly mapped to ethnicity group or utilised as proxy markers (such as language spoken) from which ethnicity could be inferred. We compared the performance of our method with the recording rates that would be identified by code lists utilised by the UK pay for the performance system, with the help of the Quality and Outcomes Framework (QOF).
Data from 2,059,453 patients across 110 practices were included. The overall categorisable ethnicity using QOF codes was 36.26% (95% confidence interval (CI): 36.20%?36.33%). This rose to 48.57% (CI:48.50%?48.64%) using the described ethnicity mapping process. Mapping increased across all ethnic groups. The largest increase was seen in the white ethnicity category (30.61%; CI: 30.55%?30.67% to 40.24%; CI: 40.17%?40.30%). The highest relative increase was in the ethnic group categorised as the other (0.04%; CI: 0.03%?0.04% to 0.92%; CI: 0.91%?0.93%).
This mapping method substantially increases the prevalence of known ethnicity in CMR data and may aid future epidemiological research based on routine data.
To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season?s vaccine.
A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data. This study builds on a feasibility study carried out at the start of the 2015/2016 influenza season. We will report influenza vaccine exposure and any AEIs reported via ADR card or recorded directly into the EHR, from the commencement of influenza vaccination and ends as specified by EMA (30 November 2016).
Ten volunteer English general practices, primarily using the GSK influenza vaccines. They had selected this vaccine in advance of the study.
People who receive a seasonal influenza vaccine, in each age group defined in EMA interim guidance: 6 months to 5 years, 6?12 years, 13?17 years, 18?65 years and >65 years.
The primary outcome measure is the rate of AEIs occurring within 7 days postvaccination, using passive surveillance of general practitioner (GP) EHR systems enhanced by a card-based ADR reporting system. Extracted data will be presented overall by brand (Fluarix Tetra vs others), by age strata and risk groups. The secondary outcome measure is the vaccine uptake among the subjects registered in the enrolled general practices.
an increased risk of acute eye infection, and prescribing of ocular antimicrobial agents.
Design and setting: A retrospective cohort study was carried out using the Royal College of
General Practitioners Research and Surveillance Centre database (RCGP RSC), a large primary
care database in the United Kingdom. We compared ocular infection rates in people aged
e15 years without diabetes to those with diabetes, both type 1 and type 2. We developed
logistic regression models to assess the excess risk in diabetes of: conjunctivitis, blepharitis,
stye/chalzion, periorbital cellulitis, keratitis/keratoconjunctivitis, lacrimal gland infection,
endopthalmitis, and ocular antimicrobial prescriptions over a six-year period (2010?2015).
We also analysed the impact of glycaemic control on infection rates in those with diabetes.
All models were adjusted for potential confounders.
Results: We analysed infection risk in 889,856 people without diabetes and 48,584 people with
diabetes (3273 type 1, and 45,311 type 2). After adjustment for confounders both type 1 and
type 2 were associated with increased incidence of conjunctivitis (OR 1.61; 95% CI 1.38?1.88;
p with blepharitis, stye/chalzion, periorbital cellulitis, keratitis/keratoconjunctivitis, lacrimal
gland infection, and endopthalmitis in the whole population. In subgroup analyses blepharitis
was more common in those with type 1 diabetes under 50 years old and endopthalmitis
in those under 50 with type 2 diabetes. Glycaemic control was not found to be associated
with any infection. Diabetes was also associated with an increased incidence of antimicrobial
prescriptions (Type 1 OR 1.69; 95% CI 1.51?1.88; p 1.13?1.20; p Conclusions: Conjunctivitis is recorded more frequently in people with diabetes. However, no
substantial increase in recording of other ocular infections was noted. Infection risk was
not found to be associated with the degree of glycaemic control
The Institute of Medicine framework defines six dimensions of quality for healthcare systems: (1) safety, (2) effectiveness, (3) patient centeredness, (4) timeliness of care, (5) efficiency, and (6) equity. Large health datasets provide an opportunity to assess quality in these areas.
To perform an international comparison of the measurability of the delivery of these aims, in people with type 2 diabetes mellitus (T2DM) from large datasets.
We conducted a survey to assess healthcare outcomes data quality of existing databases and disseminated this through professional networks. We examined the data sources used to collect the data, frequency of data uploads, and data types used for identifying people with T2DM. We compared data completeness across the six areas of healthcare quality, using selected measures pertinent to T2DM management.
We received 14 responses from seven countries (Australia, Canada, Italy, the Netherlands, Norway, Portugal, Turkey and the UK). Most databases reported frequent data uploads and would be capable of near real time analysis of healthcare quality.
The majority of recorded data related to safety (particularly medication adverse events) and treatment efficacy (glycaemic control and microvascular disease). Data potentially measuring equity was less well recorded. Recording levels were lowest for patient-centred care, timeliness of care, and system efficiency, with the majority of databases containing no data in these areas. Databases using primary care sources had higher data quality across all areas measured.
Data quality could be improved particularly in the areas of patient-centred care, timeliness, and efficiency. Primary care derived datasets may be most suited to healthcare quality assessment.
in type 2 diabetes: A systematic review and meta-analysis, Diabetes, Obesity and Metabolism 20 (4) pp. 1040-1043 Wiley
management of type 2 diabetes (T2D). We searched MEDLINE, EMBASE, the Cochrane Library,
the Register of Controlled Trials, PsychINFO and CINAHL for observational and interventional
studies that compared the adherence or persistence associated with 2 or more glucose-lowering
medications in people with T2D. Where 5 or more studies provided the same comparison, a
random-effects meta-analysis was performed, reporting mean difference (MD) or odds ratio
(OR) for adherence or persistence, depending on the pooled study outcomes. We included a total
of 48 studies. Compared with metformin, adherence (%) was better for sulphonylureas (5 studies;
MD 10.6%, 95% confidence interval [CI] 6.5-14.7) and thiazolidinediones (TZDs; 6 studies; MD
11.3%, 95% CI 2.7%-20.0%). Adherence to TZDs was marginally better than adherence to sulphonylureas
(5 studies; MD 1.5%, 95% CI 0.1-2.9). Dipeptidyl peptidase-4 inhibitors had better adherence
than sulphonylureas and TZDs. Glucagon-like peptide-1 receptor agonists had higher rates of
discontinuation than long-acting analogue insulins (6 studies; OR 1.95; 95% CI 1.17-3.27). Longacting
insulin analogues had better persistence than human insulins (5 studies; MD 43.1 days;
95% CI 22.0-64.2). The methods used to define adherence and persistence were highly variable.
In September 2015, the United Kingdom became the first country to introduce the multicomponent group B meningococcal vaccine (4CMenB) into a national infant immunisation programme. In early clinical trials 51?61% of infants developed a fever when 4CMenB was administered with other routine vaccines. Whilst administration of prophylactic paracetamol is advised, up to 3% of parents may seek medical advice for fever following vaccination. We used research-level general practitioner consultations to identify any increase in attendances for all-cause fever in vaccine-eligible infants following 4CMenB introduction in England.
Consultations for infant all-cause fever in the year following the vaccine introduction were identified from The Phoenix Partnership (TPP) ResearchOne general practice database using Read (CTV3) codes. Average daily consultation rates and incidence rate ratios (IRRs) were calculated for vaccine-eligible age groups and compared to the two years preceding vaccine introduction. The difference between pre- and post-vaccine all-cause fever consultations was estimated.
All-cause fever consultations in vaccine-eligible 7?10/week olds were 1.6-fold higher (IRR, 1.58; 95% CI, 1.22?2.05) compared to the two previous years and 1.5-fold higher (IRR 1.47; 95% CI, 1.17?1.86) in 15?18/week-olds. There were no significant differences in 0?6 or 11?14/week-olds. Applying the difference between pre- and post-vaccine consultation rates to the 4CMenB vaccine-eligible age groups across England estimated 1825 additional fever consultations in the year following 4CMenB introduction.
We found a small but significant difference in all-cause fever consultation rates in vaccine-eligible infants who would have received 4CMenB with other vaccines.
Longer medication persistence in type 2 diabetes (T2D) is associated with improved glycaemic control. It is not clear which oral therapies have the best persistence.
To compare medication persistence across different oral therapies in people with T2D.
We performed a retrospective cohort analysis using a primary care based population, the Royal College of General Practitioners Research and Surveillance Centre cohort. We identified new prescriptions for oral diabetes medication in people with type 2 diabetes between 1st January 2004 and 31st July 2015. We compared median persistence across each class (non-persistence defined as prescription gap of e 90 days). We also compared non-persistence between classes, adjusting for confounders, using Cox regression. Confounders included: age, gender, ethnicity, socioeconomic status, alcohol use, smoking status, glycaemic control, diabetes duration, diabetes complications, comorbidities, and number of previous and concurrent diabetes medications.
We identified 60,327 adults with T2D. The majority 42,810 (70.9%) of people had one or more oral medications prescribed. In these patients we measured persistence with 55,728 oral medications. Metformin had the longest median persistence (3.04 years; 95% CI 2.94 to 3.12). The adjusted hazard ratios for non-persistence compared with metformin were: sulfonylureas HR 1.20 (1.16 to 1.24), DPP-4 inhibitors HR 1.43 (1.38 to 1.49), thiazolidinediones HR 1.71 (95% CI 1.64-1.77), SGLT2 inhibitors HR 1.04 (0.93 to 1.17), meglitinides HR 2.25 (1.97 to 2.58), and alpha-glucosidase inhibitors HR 2.45 (1.98 to 3.02). The analysis of SGLT2 inhibitors was limited by the short duration of follow-up for this new class. Other factors associated with reduced medication persistence are female gender, younger age, and non-white ethnicity.
Persistence is strongly influenced by medication class and should be considered when initiating treatments.
obesity, and viral hepatitis: fourth report of the Lancet
Standing Commission on Liver Disease in the UK, The Lancet 391 (10125) pp. 1097-1107 Elsevier
Commission on Liver Disease in the UK, which aim to reduce the unacceptable harmful consequences of excess
alcohol consumption, obesity, and viral hepatitis. For alcohol, we provide data on alcohol dependence, damage to
families, and the documented increase in alcohol consumption since removal of the above-inflation alcohol duty
escalator. Alcoholic liver disease will shortly overtake ischaemic heart disease with regard to years of working life lost.
The rising prevalence of overweight and obesity, affecting more than 60% of adults in the UK, is leading to an
increasing liver disease burden. Favourable responses by industry to the UK Government?s soft drinks industry levy
have been seen, but the government cannot continue to ignore the number of adults being affected by diabetes,
hypertension, and liver disease. New direct-acting antiviral drugs for the treatment of chronic hepatitis C virus infection
have reduced mortality and the number of patients requiring liver transplantation, but more screening campaigns are
needed for identification of infected people in high-risk migrant communities, prisons, and addiction centres.
Provision of care continues to be worst in regions with the greatest socioeconomic deprivation, and deficiencies exist
in training programmes in hepatology for specialist registrars. Firm guidance is needed for primary care on the use of
liver blood tests in detection of early disease and the need for specialist referral. This report also brings together all the
evidence on costs to the National Health Service and wider society, in addition to the loss of tax revenue, with alcohol
misuse in England and Wales costing £21 billion a year (possibly up to £52 billion) and obesity costing £27 billion a
year (treasury estimates are as high as £46 billion). Voluntary restraints by the food and drinks industry have had little
effect on disease burden, and concerted regulatory and fiscal action by the UK Government is essential if the scale of
the medical problem, with an estimated 63 000 preventable deaths over the next 5 years, is to be addressed.
Physician associates are new to English general practice and set to expand
To investigate the patients? perspective on consulting with physician
associates in general practice.
A qualitative study, using semi-structured interviews, with thematic analysis.
Setting and participants:
Thirty volunteer patients of 430 who had consulted physician
associates for a same-day appointment and had returned a satisfaction survey, in six
general practices employing physician associates in England.
Some participants only consulted once with a physician associate and others
more frequently. The conditions consulted for ranged from minor illnesses to those
requiring immediate hospital admission. Understanding the role of the physician associate
varied from ?certain and correct? to ?uncertain?, to ?certain and incorrect?, where
the patient believed the physician associate to be a doctor. Most, but not all, reported
positive experiences and outcomes of their consultation, with some choosing to consult
the physician. Those with negative experiences described problems when the limits
of the role were reached, requiring additional GP consultations or prescription
delay. Trust and confidence in the physician associate was derived from trust in the
NHS, the general practice and the individual physician associate. Willingness to consult
a physician associate was contingent on the patient?s assessment of the severity
or complexity of the problem and the desire for provider continuity.
Patients saw physician associates as an appropriate general practitioner
substitute. Patients? experience could inform delivery redesign.
Methods and finding:
Multicentre, cluster-randomised controlled trial with raters masked to an online computer-generated randomisation system assessing 1 y outcome. We recruited 22 general practices (August 2013?September 2014) and 13 corresponding secondary care memory services in London, Hertfordshire, and Essex, United Kingdom. Eligible patients were aged e70 y, without a known diagnosis of dementia, living in their own homes. There were 6,387 such patients in 11 intervention practices and 8,171 in the control practices. The primary outcome was cognitive severity on Mini Mental State Examination (MMSE). Main secondary outcomes were proportion of patients consulting their GP with suspected memory disorders and proportion of those referred to memory clinics. There was no between-group difference in cognitive severity at diagnosis (99 intervention, mean MMSE = 22.04, 95% confidence intervals (CIs) = 20.95 to 23.13; 124 control, mean MMSE = 22.59, 95% CI = 21.58 to 23.6; p = 0.48). GP consultations with patients with suspected memory disorders increased in intervention versus control group (odds ratio = 1.41; 95% CI = 1.28, 1.54). There was no between-group difference in the proportions of patients referred to memory clinics (166, 2.5%; 220, 2.7%; p = .077 respectively). The study was limited as we do not know whether the additional patients presenting to GPs had objective as well as subjective memory problems and therefore should have been referred. In addition, we aimed to empower patients but did not do anything to change GP practice.
Our intervention to access timely dementia diagnosis resulted in more patients presenting to GPs with memory problems, but no diagnoses increase. We are uncertain as to the reason for this and do not know whether empowering the public and targeting GPs would have resulted in a successful intervention. Future interventions should be targeted at both patients and GPs.
Medical informatics, or biomedical and health informatics (BMHI), has become an established scientific discipline. In all such disciplines there is a certain inertia to persist in focusing on well-established research areas and to hold on to well-known research methodologies rather than adopting new ones, which may be more appropriate.
To search for answers to the following questions: What are research fields in informatics, which are not being currently adequately addressed, and which methodological approaches might be insufficiently used? Do we know about reasons? What could be consequences of change for research and for education?
Outstanding informatics scientists were invited to three panel sessions on this topic in leading international conferences (MIE 2015, Medinfo 2015, HEC 2016) in order to get their answers to these questions.
A variety of themes emerged in the set of answers provided by the panellists. Some panellists took the theoretical foundations of the field for granted, while several questioned whether the field was actually grounded in a strong theoretical foundation. Panellists proposed a range of suggestions for new or improved approaches, methodologies, and techniques to enhance the BMHI research agenda.
The field of BMHI is on the one hand maturing as an academic community and intellectual endeavour. On the other hand vendor-supplied solutions may be too readily and uncritically accepted in health care practice. There is a high chance that BMHI will continue to flourish as an important discipline; its innovative interventions might then reach the original objectives of advancing science and improving health care outcomes.
To investigate the impact of glycaemic control on infection incidence in people with Type 2 diabetes.
We compared infection rates during 2014 in people with Type 2 diabetes and people without diabetes in a large primary care cohort in the UK (the Royal College of General Practitioners Research and Surveillance Centre database). We performed multilevel logistic regression to investigate the impact of Type 2 diabetes on presentation with infection, and the effect of glycaemic control on presentation with upper respiratory tract infections, bronchitis, influenza-like illness, pneumonia, intestinal infectious diseases, herpes simplex, skin and soft tissue infections, urinary tract infections, and genital and perineal infections. People with Type 2 diabetes were stratified by good [HbA1c 69 mmol/mol (> 8.5%)] glycaemic control using their most recent HbA1c concentration. Infection incidence was adjusted for important sociodemographic factors and patient comorbidities.
We identified 34 278 people with Type 2 diabetes and 613 052 people without diabetes for comparison. The incidence of infections was higher in people with Type 2 diabetes for all infections except herpes simplex. Worsening glycaemic control was associated with increased incidence of bronchitis, pneumonia, skin and soft tissue infections, urinary tract infections, and genital and perineal infections, but not with upper respiratory tract infections, influenza-like illness, intestinal infectious diseases or herpes simplex.
Almost all infections analysed were more common in people with Type 2 diabetes. Infections that are most commonly of bacterial, fungal or yeast origin were more frequent in people with worse glycaemic control.
Allergic rhinitis (AR) is a global health problem, potentially impacting individuals? sleep, work and social life. We aimed to use a surveillance network of general practitioners (GPs) to describe the epidemiology of AR consultations in England.
A large GP surveillance network covering approximately 53% of the English population.
GP consultations for AR across England between 30 December 2002 and 31 December 2014 were analysed. Using more granular data available between 2 April 2012 and 31 December 2014 rates and rate ratios (RR) of AR were further analysed in different age groups, gender, rural-urban classification and index of multiple deprivation score quintile of location of GP.
The mean weekly rate for AR consultations was 19.8 consultations per 100 000 GP registered patients (range 1.13?207), with a regular peak occurring during June (weeks 24?26), and a smaller peak during April. Between 1 April 2012 and 31 December 2014, the highest mean daily rates of consultations per 1 00 000 were: in age group 5?14 years (rate=8.02, RR 6.65, 95% CI 6.38 to 6.93); females (rate=4.57, RR 1.12 95% CI 1.12 to 1.13); persons registered at a GP in the most socioeconomically deprived quintile local authority (rate=5.69, RR 1.48, 95% CI 1.47 to 1.49) or in an urban area with major conurbation (rate=5.91, RR 1.78, 95% CI 1.69 to 1.87).
AR rates were higher in those aged 5?14 years, females and in urban and socioeconomically deprived areas. This needs to be viewed in the context of this study?s limitations but should be considered in health promotion and service planning.
There are limited case-mix classification systems for primary care settings which are applicable when considering the optimal clinical skill mix to provide services.
To develop a case-mix classification system (CMCS) and test its impact on analyses of patient outcomes by clinician type, using example data from physician associates? (PAs) and GPs' consultations with same-day appointment patients.
Design & setting
Secondary analysis of controlled observational data from six general practices employing PAs and six matched practices not employing PAs in England.
Routinely-collected patient consultation records (PA n = 932, GP n = 1154) were used to design the CMCS (combining problem codes, disease register data, and free text); to describe the case-mix; and to assess impact of statistical adjustment for the CMCS on comparison of outcomes of consultations with PAs and with GPs.
A CMCS was developed by extending a system that only classified 18.6% (213/1147) of the presenting problems in this study's data. The CMCS differentiated the presenting patient?s level of need or complexity as: acute, chronic, minor problem or symptom, prevention, or process of care, applied hierarchically. Combination of patient and consultation-level measures resulted in a higher classification of acuity and complexity for 639 (30.6%) of patient cases in this sample than if using consultation level alone. The CMCS was a key adjustment in modelling the study?s main outcome measure, that is rate of repeat consultation.
This CMCS assisted in classifying the differences in case-mix between professions, thereby allowing fairer assessment of the potential for role substitution and task shifting in primary care, but it requires further validation.
RESEARCH DESIGN AND METHODS: Primary care records in England (n = 2,360,631) were searched for incident cases of adult-onset diabetes between 1 January 2005 and 31 March 2016. We examined demographics, diabetes classification, glycemic control, and insulin use in those with and without pancreatic disease (subcategorized into acute pancreatitis or chronic pancreatic disease) before diabetes diagnosis. Regression analysis was used to control for baseline potential risk factors for poor glycemic control (HbA1c e7% [53 mmol/mol]) and insulin requirement.
RESULTS: We identified 31,789 new diagnoses of adult-onset diabetes. Diabetes following pancreatic disease (2.59 [95% CI 2.38?2.81] per 100,000 person-years) was more common than type 1 diabetes (1.64 [1.47?1.82]; P
CONCLUSIONS: Diabetes of the exocrine pancreas is frequently labeled type 2 diabetes but has worse glycemic control and a markedly greater requirement for insulin.
To assess the association between anticoagulation, ischaemic stroke, gastrointestinal and cerebral haemorrhage, and all cause mortality in older people with atrial fibrillation and chronic kidney disease.
Propensity matched, population based, retrospective cohort analysis from January 2006 through December 2016.
The Royal College of General Practitioners Research and Surveillance Centre database population of almost 2.73 million patients from 110 general practices across England and Wales.
Patients aged 65 years and over with a new diagnosis of atrial fibrillation and estimated glomerular filtration rate (eGFR) of
Receipt of an anticoagulant prescription within 60 days of atrial fibrillation diagnosis.
Main outcome measures
Ischaemic stroke, cerebral or gastrointestinal haemorrhage, and all cause mortality.
6977 patients with chronic kidney disease and newly diagnosed atrial fibrillation were identified, of whom 2434 were on anticoagulants within 60 days of diagnosis and 4543 were not. 2434 pairs were matched using propensity scores by exposure to anticoagulant or none and followed for a median of 506 days. The crude rates for ischaemic stroke and haemorrhage were 4.6 and 1.2 after taking anticoagulants and 1.5 and 0.4 in patients who were not taking anticoagulant per 100 person years, respectively. The hazard ratios for ischaemic stroke, haemorrhage, and all cause mortality for those on anticoagulants were 2.60 (95% confidence interval 2.00 to 3.38), 2.42 (1.44 to 4.05), and 0.82 (0.74 to 0.91) compared with those who received no anticoagulation.
Giving anticoagulants to older people with concomitant atrial fibrillation and chronic kidney disease was associated with an increased rate of ischaemic stroke and haemorrhage but a paradoxical lowered rate of all cause mortality. Careful consideration should be given before starting anticoagulants in older people with chronic kidney disease who develop atrial fibrillation. There remains an urgent need for adequately powered randomised trials in this population to explore these findings and to provide clarity on correct clinical management.
A systematic review and cohort analyses of comparative adherence and persistence across medication classes in T2D was performed. MEDLINE, Embase, The Cochrane Library, The Cochrane Register of Controlled Trials, PsycINFO, and CINAHL were searched for studies comparing class adherence and persistence. Where n>5 studies provided the same comparison a meta-analysis was performed. Retrospective cohort analyses used the Royal College of General Practitioners Research and Surveillance database to compare adherence and persistence with oral medications.
The systematic review synthesised 66 studies (38 in meta-analyses). Adherence was better with thiazolidinediones (TZDs) and sulphonylureas than metformin. TZDs had slightly better adherence than sulphonylureas. Limited data suggest low adherence with alpha-glucosidase inhibitors (AGIs) and meglitinides. Insulin analogues had longer persistence than GLP1 analogues and human insulins. There was little data on comparative persistence with oral medications and adherence with injectable medications. Adherence and persistence were measured in cohorts of 60,327 and 145,546 people with T2D respectively (55,728 and 76,593 oral medications). After adjustment in regression models metformin and SGLT2 inhibitors had the longest persistence, AGIs and meglitinides the shortest. TZDs, DPP4 inhibitors, and SGLT2 inhibitors had the highest adherence, and metformin, AGIs and meglitinides the lowest. Sulphonylureas had intermediate adherence and persistence. Younger age, female gender, and non-white ethnicity were also associated with reduced persistence and adherence.
Adherence and persistence vary considerable between classes of medication for T2D. Class switching may improve adherence in people with low adherence e.g. metformin to DPP4 inhibitors. Pre-emptive selection of classes which promote adherence in those with non-adherence risk factors may also improve outcomes.
Over 70% of the health-care budget in England is spent on the care of people with long-term
conditions (LTCs), and a major cost component is unscheduled health care. Psychological morbidity is high in
people with LTCs and is associated with a range of adverse outcomes, including increased mortality, poorer
physical health outcomes, increased health costs and service utilisation.
The aim of this programme of research was to examine the relationship between
psychological morbidity and use of unscheduled care in people with LTCs, and to develop a psychosocial
intervention that would have the potential to reduce unscheduled care use. We focused largely on
emergency hospital admissions (EHAs) and attendances at emergency departments (EDs).
A three-phase mixed-methods study. Research methods included systematic reviews; a
longitudinal prospective cohort study in primary care to identify people with LTCs at risk of EHA or ED
admission; a replication study in primary care using routinely collected data; an exploratory and feasibility
cluster randomised controlled trial in primary care; and qualitative studies to identify personal reasons
for the use of unscheduled care and factors in routine consultations in primary care that may influence
health-care use. People with lived experience of LTCs worked closely with the research team.
Setting: Primary care. Manchester and London.
Participants: People aged e 18 years with at least one of four common LTCs: asthma, coronary
heart disease, chronic obstructive pulmonary disease (COPD) and diabetes. Participants also included
Evidence synthesis suggested that depression, but not anxiety, is a predictor of use of unscheduled
care in patients with LTCs, and low-intensity complex interventions reduce unscheduled care use in people
with asthma and COPD. The results of the prospective study were that depression, not having a partner
and life stressors, in addition to prior use of unscheduled care, severity of illness and multimorbidity, were
independent predictors of EHA and ED admission. Approximately half of the cost of health care for people
with LTCs was accounted for by use of unscheduled care. The results of the replication study, carried out in
London, broadly supported our findings for risk of ED attendances, but not EHAs. This was most likely due to
low rates of detection of depression in general practitioner (GP) data sets. Qualitative work showed that
patients were reluctant to use unscheduled care, deciding to do so when they perceived a serious and urgent
need for care, and following previous experience that unscheduled care had successfully and unquestioningly
met similar needs in the past. In general, emergency and primary care doctors did not regard unscheduled
care as problematic. We found there are missed opportunities to identify and discuss psychosocial issues
during routine consultations in primary care due to the ?overmechanisation? of routine health-care reviews.
The feasibility trial examined two levels of an intervention for people with COPD: we tried to improve the
way in which practices manage patients with COPD and developed a targeted psychosocial treatment for
patients at risk of using unscheduled care. The former had low acceptability, whereas the latter had high
acceptability. Exploratory health economic analyses suggested that the practice-level intervention would be
unlikely to be cost-effective, limiting the value of detailed health economic modelling.
The findings of this programme may not apply to all people with LTCs. It was conducted in
an area of high social deprivation, which may limit the generalisability to more affluent areas. The response
rate to the prospective longitudinal study was low. The feasibility trial focused solely on people with COPD.
Conclusions: Prior use of unscheduled care is the most powerful predictor of unscheduled care use in
To characterize the risk uveitis, scleritis or episcleritis in relation to diabetes, glycaemic control, and co-existence of retinopathy.
Using the Royal College of General Practitioners Research and Surveillance Centre database, we established the prevalence of acute uveitis and scleritis or episcleritis over a six-year period among populations without(n/=/889,856) and with diabetes(n/=/48,584). We evaluated the impact of glycaemic control on disease risk. Regression modeling was used to identify associations, adjusting for clinical and demographic confounders.
Incidence of acute uveitis was higher among patients with diabetes; Type 1 OR:2.01 (95% CI 1.18?3.41; p/=/0.009), and Type 2 OR:1.23 (1.05?1.44; p/=/0.01). Glycaemic control was established as an important effect modifier for uveitis risk, whereby those with poorer control suffered higher disease burden. Results confirmed a dose-response relationship such that very poor glycaemic control OR:4.72 (2.58?8.65; p/0.001), poor control OR:1.57 (1.05?2.33; p/=/0.03) and moderate control OR:1.20 (0.86?1.68; p/=/0.29) were predictive of uveitis. Similar results were observed when evaluating retinopathy staging: proliferative retinopathy OR:2.42 (1.25?4.69; p/=/0.01). These results were not maintained for scleritis or episcleritis.
Acute uveitis is more common in patients with diabetes; at highest risk are those with type 1 disease with poor glycaemic control. Glycaemic improvements may prevent recurrence.
To appraise and synthesise research on the impact of physician assistants/associates (PA) in secondary care, specifically acute internal medicine, care of the elderly, emergency medicine, trauma and orthopaedics, and mental health.
Electronic databases (Medline, Embase, ASSIA, CINAHL, SCOPUS, PsycINFO, Social Policy and Practice, EconLit and Cochrane), reference lists and related articles.
Peer-reviewed articles of any study design, published in English, 1995?2017.
Blinded parallel processes were used to screen abstracts and full text, data extractions and quality assessments against published guidelines. A narrative synthesis was undertaken.
Impact on: patients? experiences and outcomes, service organisation, working practices, other professional groups and costs.
5472 references were identified and 161 read in full; 16 were included?emergency medicine (7), trauma and orthopaedics (6), acute internal medicine (2), mental health (1) and care of the elderly (0). All studies were observational, with variable methodological quality. In emergency medicine and in trauma and orthopaedics, when PAs are added to teams, reduced waiting and process times, lower charges, equivalent readmission rate and good acceptability to staff and patients are reported. Analgesia prescribing, operative complications and mortality outcomes were variable. In internal medicine outcomes of care provided by PAs and doctors were equivalent.
PAs have been deployed to increase the capacity of a team, enabling gains in waiting time, throughput, continuity and medical cover. When PAs were compared with medical staff, reassuringly there was little or no negative effect on health outcomes or cost. The difficulty of attributing cause and effect in complex systems where work is organised in teams is highlighted. Further rigorous evaluation is required to address the complexity of the PA role, reporting on more than one setting, and including comparison between PAs and roles for which they are substituting.