Professor Simon de Lusignan


Professor of Primary Care and Clinical Informatics, and Vice Chancellor's Fellow
BSc MBBS MSc FBCS CITP FACHI FFCI FRCGP
Principal academic post now at University of Oxford
Personal assistant: Jolanta Parkinson
+44 (0)1865 289 344

Biography

My publications

Publications

Claire Kelly, Marinos Pericleous, Ayesha Ahmed, Tushna Vandrevala, Jane Hendy, Shuja Shafi, Simon S Skene, Sumita Verma, Chantal Edge, Margot Nicholls, Charles Gore, Simon de Lusignan, Aftab Ala (2020)Improving uptake of hepatitis B and hepatitis C testing in South Asian migrants in community and faith settings using educational interventions—A prospective descriptive study, In: International Journal of Infectious Diseases100pp. 264-272 Elsevier Ltd

Background Chronic viral hepatitis (CVH) is a leading contributor to the UK liver disease epidemic, with global migration from high prevalence areas (e.g., South Asia). Despite international guidance for testing high-risk groups in line with elimination targets, there is no consensus on how to achieve this. The objectives of this study were to assess the following: (1) the feasibility of recruiting South Asian migrants to view an educational film on CVH, (2) the effectiveness of the film in promoting testing and increasing knowledge of CVH, and (3) the methodological issues relevant to scale-up to a randomized controlled trial. Methods South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with dried blood spot CVH testing offered immediately afterwards. Pre/post-film questionnaires assessed the effectiveness of the intervention. Results Two hundred and nineteen first-generation migrants ≥18 years of age (53% female) were recruited to view the film at the following sites: religious, n = 112 (51%), community n = 98 (45%), and primary care, n = 9 (4%). One hundred and eighty-four (84%) underwent CVH testing; hepatitis B core antibody or hepatitis C antibody positivity demonstrated exposure in 8.5%. Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed. Conclusions This study demonstrated the feasibility of recruiting first-generation migrants to view a community-based educational film promoting CVH testing in this higher risk group, confirming the value of developing interventions to facilitate the global World Health Organization plan for targeted case finding and elimination, and a future randomized controlled trial. We highlight the importance of culturally relevant interventions including faith and culturally sensitive settings, which appear to minimize logistical issues and effectively engage minority groups, allowing ease of access to individuals ‘at risk’.

Andrew Mcgovern, W Hinton, S Calderara, N Munro, Martin Whyte, Simon de Lusignan (2018)A class comparison of medication persistence in people with type 2 diabetes: a retrospective observational study, In: Diabetes Therapy9(1)pp. 229-242 Springer Verlag

Background: 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. Objective: To compare medication persistence across different oral therapies in people with T2D. Methods: 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 ≥ 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. Results: 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. Conclusions: Persistence is strongly influenced by medication class and should be considered when initiating treatments.

MI Smith, S de Lusignan, D Mullett, A Correa, J Tickner, S Jones (2016)Predicting Falls and When to Intervene in Older People: A Multilevel Logistical Regression Model and Cost Analysis, In: PLoS One11(7) Public Library of Science (PLoS)

Introduction Falls are the leading cause of injury in older people. Reducing falls could reduce financial pressures on health services. We carried out this research to develop a falls risk model, using routine primary care and hospital data to identify those at risk of falls, and apply a cost analysis to enable commissioners of health services to identify those in whom savings can be made through referral to a falls prevention service. Methods Multilevel logistical regression was performed on routinely collected general practice and hospital data from 74751 over 65’s, to produce a risk model for falls. Validation measures were carried out. A cost-analysis was performed to identify at which level of risk it would be cost-effective to refer patients to a falls prevention service. 95% confidence intervals were calculated using a Monte Carlo Model (MCM), allowing us to adjust for uncertainty in the estimates of these variables. Results A risk model for falls was produced with an area under the curve of the receiver operating characteristics curve of 0.87. The risk cut-off with the highest combination of sensitivity and specificity was at p = 0.07 (sensitivity of 81% and specificity of 78%). The risk cut-off at which savings outweigh costs was p = 0.27 and the risk cut-off with the maximum savings was p = 0.53, which would result in referral of 1.8% and 0.45% of the over 65’s population respectively. Above a risk cut-off of p = 0.27, costs do not exceed savings. Conclusions This model is the best performing falls predictive tool developed to date; it has been developed on a large UK city population; can be readily run from routine data; and can be implemented in a way that optimises the use of health service resources. Commissioners of health services should use this model to flag and refer patients at risk to their falls service and save resources

Prashant Kumar, Angela Druckman, John Gallagher, Birgitta Gatersleben, Sarah Allison, Theodore S. Eisenman, Uy Hoang, Sarkawt Hama, Arvind Tiwari, Ashish Sharma, K V Abhijith, Deepti Adlakha, Aonghus McNabola, Thomas Astell-Burt, Xiaoqi Feng, Anne Skeldon, Simon de Lusignan, Lidia Morawska (2019)The Nexus between Air Pollution, Green Infrastructure and Human Health, In: Environment International133 A105181 Elsevier

Cities are constantly evolving and so are the living conditions within and between them. Rapid urbanization and the ever-growing need for housing have turned large areas of many cities into concrete landscapes that lack greenery. Green infrastructure can support human health, provide socio-economic and environmental benefits, and bring color to an otherwise grey urban landscape. Sometimes, benefits come with downsides in relation to its impact on air quality and human health, requiring suitable data and guidelines to implement effective greening strategies. Air pollution and human health, as well as green infrastructure and human health, are often studied together. Linking green infrastructure with air quality and human health together is a unique aspect of this article. A holistic understanding of these links is key to enabling policymakers and urban planners to make informed decisions. By critically evaluating the link between green infrastructure and human health via air pollution mitigation, we also discuss if our existing understanding of such interventions is enabling their uptake in practice. Both the natural science and epidemiology approach the topic of green infrastructure and human health very differently. The pathways linking health benefits to pollution reduction by urban vegetation remain unclear and that the mode of green infrastructure deployment is critical to avoid unintended consequences. Strategic deployment of green infrastructure may reduce downwind pollution exposure. However, the development of bespoke design guidelines is vital to promote and optimize greening benefits and measuring green infrastructure’s socio-economic and health benefits are key for their uptake. Greening cities to mitigate pollution effects is on the rise and these needs to be matched by scientific evidence and appropriate guidelines. We conclude that urban vegetation can facilitate broad health benefits, but there is little empirical evidence linking these benefits to air pollution reduction by urban vegetation, and appreciable efforts are needed to establish the underlying policies, design and engineering guidelines governing its deployment.

HS Liyanage, D Luzi, S de Lusignan, F Pecoraro, R McNulty, O Tamburis, P Krause, M Rigby, M Blair (2016)Accessible Modelling of Complexity in Health and associated data flows: asthma as an exemplar, In: Journal of Innovation in Health Informatics23(1)pp. 476-484 BCS, The Chartered Institute for IT

Background: Modelling is an important part of information science. Models are abstractions of reality. We use models in the following contexts: (1) to describe the data and information flows in clinical practice to information scientists, (2) to compare health systems and care pathways, (3) to understand how clinical cases are recorded in record systems and (4) to model health care business models. 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.

M Halter, C Wheeler, VM Drennan, Simon de Lusignan, R Grant, J Gabe, Heather Gage, J Ennis, J Parle (2017)Physician associates in England's hospitals: a survey of medical directors exploring current usage and factors affecting recruitment, In: Clinical Medicine17(2)pp. 126-131 Royal College of Physicians

In the UK secondary care setting, the case for physician associates is based on the cover and stability they might offer to medical teams. We assessed the extent of their adoption and deployment - that is, their current usage and the factors supporting or inhibiting their inclusion in medical teams - using an electronic, self-report survey of medical directors of acute and mental health NHS trusts in England. Physician associates - employed in small numbers, in a range of specialties, in 20 of the responding trusts - were reported to have been employed to fill gaps in medical staffing and support medical specialty trainees. Inhibiting factors were commonly a shortage of physician associates to recruit and lack of authority to prescribe, as well as a lack of evidence and colleague resistance. Our data suggest there is an appetite for employment of physician associates while practical and attitudinal barriers are yet to be fully overcome.

S De Lusignan, AP McGovern, MA Tahir, S Hassan, S Jones, M Halter, L Joly, VM Drennan (2016)Physician associate and general practitioner consultations: A comparative observational video study, In: PLoS ONE11(8)

Background: Physician associates, known internationally as physician assistants, are a mid-level practitioner, well established in the United States of America but new to the United Kingdom. A small number work in primary care under the supervision of general practitioners, where they most commonly see patients requesting same day appointments for new problems. As an adjunct to larger study, we investigated the quality of the patient consultation of physician associates in comparison to that of general practitioners. Method: We conducted a comparative observational study using video recordings of consultations by volunteer physician associates and general practitioners with consenting patients in single surgery sessions. Recordings were assessed by experienced general practitioners, blinded to the type of the consulting practitioner, using the Leicester Assessment Package. Assessors were asked to comment on the safety of the recorded consultations and to attempt to identify the type of practitioner. Ratings were compared across practitioner type, alongside the number of presenting complaints discussed in each consultation and the number of these which were acute, minor, or regarding a chronic condition. Results: We assessed 62 consultations (41 general practitioner and 21 physician associates) from five general practitioners and four physician associates. All consultations were assessed as safe; but general practitioners were rated higher than PAs in all elements of consultation. The general practitioners were more likely than physician associates to see people with multiple presenting complaints (p

Agnieszka Lemanska, Rachel C. Byford, Clare Cruickshank, David P. Deamaley, Filipa Ferreira, Clare Griffin, Emma Hall, William Hinton, Simon de Lusignan, Julian Sherlock, Sara Faithfull (2020)Linkage of the CHHiP randomised controlled trial with primary care data. A study investigating ways of supplementing cancer trials and improving evidence-based practice., In: BMC Medical Research Methodology BMC

Background: Randomised controlled trials (RCTs) are the gold standard for evidence-based practice. However, RCTs can have limitations. For example, translation of findings into practice can be limited by design features, such as inclusion criteria, not accurately reflecting clinical populations. In addition, it is expensive to recruit and follow-up participants in RCTs. Linkage with routinely collected data could offer a cost-effective way to enhance the conduct and generalisability of RCTs. The aim of this study is to investigate how primary care data can support RCTs. Methods: Secondary analysis following linkage of two datasets: 1) multicentre CHHiP radiotherapy trial (ISRCTN97182923) and 2) primary care database from the Royal College of General Practitioners Research and Surveillance Centre. Comorbidities and medications recorded in CHHiP at baseline, and radiotherapy-related toxicity recorded in CHHiP over time were compared with primary care records. The association of comorbidities and medications with toxicity was analysed with mixed-effects logistic regression. Results: Primary care records were extracted for 106 out of 2811 CHHiP participants recruited from sites in England (median age 70, range 44 to 82). Complementary information included longitudinal body mass index, blood pressure and cholesterol, as well as baseline smoking and alcohol usage but was limited by the considerable missing data. In the linked sample, 9 (8%) participants were recorded in CHHiP as having a history of diabetes and 38 (36%) hypertension, whereas primary care records indicated incidence prior to trial entry of 11 (10%) and 40 (38%) respectively. Concomitant medications were not collected in CHHiP but available in primary care records. This indicated that 44 (41.5%) men took aspirin, 65 (61.3%) statins, 14 (13.2%) metformin and 46 (43.4%) phosphodiesterase-5-inhibitors at some point before or after trial entry. Conclusions: People develop new comorbidities and commence medications after enrolment to trials. Data recorded in primary care are a rich resource and linkage could provide near real-time information to supplement trials and an efficient and cost-effective mechanism for long-term follow-up. In addition, standardised primary care data extracts could form part of RCT recruitment and conduct. However, this is at present limited by the variable quality and fragmentation of primary care data.

D Todkill, P Loveridge, AJ Elliot, R Morbey, Simon de Lusignan, O Edeghere, G Smith (2017)Socioeconomic and geographical variation in general practitioner consultations for allergic rhinitis in England, 2003-2014: an observational study, In: BMJ Open7(8)e017038 BMJ Publishing Group

Objective 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. Setting A large GP surveillance network covering approximately 53% of the English population. Methods 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. Results 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). Conclusions 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.

Louise Rayner, Andrew Mcgovern, Ben Creagh-Brown, Chris Woodmansey, Simon de Lusignan (2019)Type 2 Diabetes and Asthma: Systematic Review of the Bidirectional Relationship, In: Current diabetes reviews15(2)pp. 118-126 Bentham Science Publishers

Background and Objective: Obesity is an important contributor to the risk of both asthma and Type 2 Diabetes (T2DM). However, it has been suggested that T2DM and asthma are also independently associated. The aim of this systematic review was to synthesize the evidence for an independent relationship between T2DM and asthma. Methods: MEDLINE and EMBASE were searched for studies reporting the relationship between asthma and T2DM in adults. Given a potential bidirectional relationship, articles relating to T2DM as a risk factor for asthma, and asthma as a risk factor for T2DM were examined separately. Results: Eight studies were identified for inclusion in the review (n=2,934,399 participants). Four studies examined incident diabetes in those with asthma. The pooled (random effects model) adjusted hazard ratio for incident T2DM in asthma was 1.37 (95%CI 1.12-1.69; p ˂0.001) after controlling for BMI. Four studies reported prevalence or incidence rates of asthma in people with T2DM; higher rates of asthma in those with T2DM were reported in all four studies. Meta-analysis of results was not possible due to methodological heterogeneity. The quality of included studies was good, but due to small numbers, publication bias cannot be excluded. Conclusion: The published literature suggests a bidirectional independent relationship between T2DM and asthma, although we cannot exclude publication bias.

VM Drennan, M Halter, L Joly, Heather Gage, RL Grant, J Gabe, S Brearley, W Carneiro, Simon de Lusignan (2015)Physician associates and GPs in primary care: a comparison, In: BRITISH JOURNAL OF GENERAL PRACTICE65(634)pp. e344-e350 ROYAL COLL GENERAL PRACTITIONERS

Physician associates [PAs] (also known as 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.

M Halter, VM Drennan, LM Joly, J Gabe, Heather Gage, Simon de Lusignan (2017)Patients’ experiences of consultations with physician associates in primary care in England: A qualitative study, In: Health Expectations20pp. 1011-1019 Wiley Open Access

Background: Physician associates are new to English general practice and set to expand in numbers. Objective: To investigate the patients’ perspective on consulting with physician associates in general practice. Design: 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. Findings: 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. Conclusion: Patients saw physician associates as an appropriate general practitioner substitute. Patients’ experience could inform delivery redesign.

M Halter, L Joly, Simon de Lusignan, R Grant, Heather Gage, V Drennan (2018)Capturing complexity in clinician case-mix: classification system development using GP and physician associate data, In: BJGP Open Royal College of General Practitioners

Background There are limited case-mix classification systems for primary care settings which are applicable when considering the optimal clinical skill mix to provide services. Aim 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. Method 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. Results 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. Conclusion 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.

S de Lusignan, F Mold, A Sheikh, A Majeed, JC Wyatt, T Quinn, M Cavill, TA Gronlund, C Franco, U Chauhan, H Blakey, N Kataria, F Barker, B Ellis, P Koczan, TN Arvanitis, M McCarthy, S Jones, I Rafi (2014)Patients’ online access to their electronic health records and linked online services: an interpretative review., In: BMJ Open4 BMJ Publishing Group

Objectives: To investigate the effect of providing patients online access to their electronic health record (EHR) and linked transactional services on the provision, quality and safety of healthcare. The objectives are also to identify and understand: barriers and facilitators for providing online access to their records and services for primary care workers; and their association with organisational/IT system issues. Setting: Primary care. Participants: A total of 143 studies were included. 17 were experimental in design and subject to risk of bias assessment, which is reported in a separate paper. Detailed inclusion and exclusion criteria have also been published elsewhere in the protocol. Primary and secondary outcome measures: Our primary outcome measure was change in quality or safety as a result of implementation or utilisation of online records/transactional services. Results: No studies reported changes in health outcomes; though eight detected medication errors and seven reported improved uptake of preventative care. Professional concerns over privacy were reported in 14 studies. 18 studies reported concern over potential increased workload; with some showing an increase workload in email or online messaging; telephone contact remaining unchanged, and face-to face contact staying the same or falling. Owing to heterogeneity in reporting overall workload change was hard to predict. 10 studies reported how online access offered convenience, primarily for more advantaged patients, who were largely highly satisfied with the process when clinician responses were prompt. Conclusions: Patient online access and services offer increased convenience and satisfaction. However, professionals were concerned about impact on workload and risk to privacy. Studies correcting medication errors may improve patient safety. There may need to be a redesign of the business process to engage health professionals in online access and of the EHR to make it friendlier and provide equity of access to a wider group of patients.

G Livingston, G Baio, A Sommerlad, Simon de Lusignan, S Poulimenos, S Morris, G Rait, J Hoe (2017)Effectiveness of an intervention to facilitate prompt referral to memory clinics in the United Kingdom: Cluster randomised controlled trial, In: PLoS Med14(3)e1002252 Public Library of Science

Background: Most people with dementia do not receive timely diagnosis, preventing them from making informed plans about their future and accessing services. Many countries have a policy to increase timely diagnosis, but trials aimed at changing general practitioner (GP) practice have been unsuccessful. We aimed to assess whether a GP’s personal letter, with an evidence-based leaflet about overcoming barriers to accessing help for memory problems—aimed at empowering patients and families—increases timely dementia diagnosis and patient presentation to general practice. 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 ≥70 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. Conclusions: 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.

F Mold, B Ellis, S de Lusignan, A Sheikh, JC Wyatt, M Cavill, G Michalakidis, F Barker, A Majeed, T Quinn, P Koczan, T Avanitis, TA Gronlund, C Franco, M McCarthy, Z Renton, U Chauhan, H Blakey, N Kataria, S Jones, I Rafi (2012)The provision and impact of online patient access to their electronic health records (EHR) and transactional services on the quality and safety of health care: systematic review protocol, In: Informatics In Primary Care20(4)pp. 271-282 Radcliffe

Background: Innovators have piloted improvements in communication, changed patterns of practice and patient empowerment from online access to electronic health records (EHR). International studies of online services, such as prescription ordering, online appointment booking and secure communications with primary care, show good uptake of email consultations, accessing test results and booking appointments; when technologies and business process are in place. Online access and transactional services are due to be rolled out across England by 2015; this review seeks to explore the impact of online access to health records and other online services on the quality and safety of primary health care. 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.

R Williams, G Alexander, I Armstrong, A Baker, N Bhala, G Camps-Walsh, M Cramp, Simon de Lusignan, N Day, A Dhawan, J Dillon, C Drummond, J Dyson, G Foster, I Gilmore, M Hudson, D Kelly, A Langford, N McDougall, P Meier, K Moriarty, P Newsome, J O’Grady, R Pryke, L Rolfe, P Rice, H Rutter, N Sheron, A Taylor, J Thompson, D Thorburn, J Verne, J Wass, A Yeoman (2017)Disease burden and costs from excess alcohol consumption, obesity, and viral hepatitis: fourth report of the Lancet Standing Commission on Liver Disease in the UK, In: The Lancet391(10125)pp. 1097-1107 Elsevier

This report contains new and follow-up metric data relating to the eight main recommendations of the Lancet Standing 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.

Freda Elizabeth Mold, Jane Hendy, Yi-Ling Lai, Simon de Lusignan (2019)Electronic Consultation in Primary Care Between Providers and Patients: Systematic Review, In: JMIR Medical Informatics7(4)e13042 JMIR Publications

Background: Governments and health care providers are keen to find innovative ways to deliver care more efficiently. Interest in electronic consultation (e-consultation) has grown, but the evidence of benefit is uncertain. Objective: This study aimed to assess the evidence of delivering e-consultation using secure email and messaging or video links in primary care. Methods: A systematic review was conducted on the use and application of e-consultations in primary care. We searched 7 international databases (MEDLINE, EMBASE, CINAHL, Cochrane Library, PsycINFO, EconLit, and Web of Science; 1999-2017), identifying 52 relevant studies. Papers were screened against a detailed inclusion and exclusion criteria. Independent dual data extraction was conducted and assessed for quality. The resulting evidence was synthesized using thematic analysis. Results: This review included 57 studies from a range of countries, mainly the United States (n=30) and the United Kingdom (n=13). There were disparities in uptake and utilization toward more use by younger, employed adults. Patient responses to e-consultation were mixed. Patients reported satisfaction with services and improved self-care, communication, and engagement with clinicians. Evidence for the acceptability and ease of use was strong, especially for those with long-term conditions and patients located in remote regions. However, patients were concerned about the privacy and security of their data. For primary health care staff, e-consultation delivers challenges around time management, having the correct technological infrastructure, whether it offers a comparable standard of clinical quality, and whether it improves health outcomes. Conclusions: E-consultations may improve aspects of care delivery, but the small scale of many of the studies and low adoption rates leave unanswered questions about usage, quality, cost, and sustainability. We need to improve e-consultation implementation, demonstrate how e-consultations will not increase disparities in access, provide better reassurance to patients about privacy, and incorporate e-consultation as part of a manageable clinical workflow.

Mary Halter, Vari Drennan, Chao Wang, Carly Wheeler, Heather Gage, Laura Nice, Simon de Lusignan, Jonathan Gabe, Sally Brearley, James Ennis, Phil Begg, Jim Parle (2020)Comparing physician associates and foundation year two doctors-in-training undertaking emergency medicine consultations in England: a mixed-methods study of processes and outcomes, In: BMJ open10(9)e037557

Objectives: To compare the contribution of physician associates to the processes and outcomes of emergency medicine consultations with that of foundation year two doctors-in-training. Design: Mixed-methods study: retrospective chart review using 4 months’ anonymised clinical record data of all patients seen by physician associates or foundation year two doctors-in-training in 2016; review of a subsample of 40 records for clinical adequacy; semi-structured interviews with staff and patients; observations of physician associates. Setting: Three emergency departments in England. Participants: The records of 8816 patients attended by 6 physician associates and 40 foundation year two doctors-in-training; of these n=3197 had the primary outcome recorded (n=1129 physician associates, n=2068 doctor); 14 clinicians and managers and 6 patients or relatives for interview; 5 physician associates for observation. Primary and secondary outcome measures: The primary outcome was unplanned re-attendance at the same emergency department within 7 days. Secondary outcomes: consultation processes, clinical adequacy of care, and staff and patient experience. Results: Re-attendances within 7 days (n=194 (6.1%)) showed no difference between physician associates and foundation year two doctors-in-training (OR 0.87, 95% CI 0.61 to 1.24, p=0.437). If seen by a physician associate, patients were more likely receive an X-ray investigation (OR 2.10, 95% CI 1.72 to 4.24), p

Bernardo Meza-Torres, Fabrizio Carinci, Christian Heiss, Mark Joy, Simon de Lusignan (2021)Health service organisation impact on lower extremity amputations in people with type 2 diabetes with foot ulcers: systematic review and meta-analysis, In: Acta Diabetologicapp. 1-13

Despite the evidence available on the epidemiology of diabetic foot ulcers and associated complications, it is not clear how specific organizational aspects of health care systems can positively affect their clinical trajectory. We aim to evaluate the impact of organizational aspects of care on lower extremity amputation rates among people with type 2 diabetes affected by foot ulcers. We conducted a systematic review of the scientific literature published between 1999 and 2019, using the following key terms as search criteria: people with type 2 diabetes, diagnosed with diabetic foot ulcer, treated with specific processes and care pathways, and LEA as primary outcome. Overall results were reported as pooled odds ratios and 95% confidence intervals obtained using fixed and random effects models. A total of 57 studies were found eligible, highlighting the following arrangements: dedicated teams, care pathways and protocols, multidisciplinary teams, and combined interventions. Among them, seven studies qualified for a meta-analysis. According to the random effects model, interventions including any of the four arrangements were associated with a 29% reduced risk of any type of lower extremity amputation (OR = 0.71; 95% CI 0.52-0.96). The effect was larger when focusing on major LEAs alone, leading to a 48% risk reduction (OR = 0.52; 95% CI 0.30-0.91). Specific organizational arrangements including multidisciplinary teams and care pathways can prevent half of the amputations in people with diabetes and foot ulcers. Further studies using standardized criteria are needed to investigate the cost-effectiveness to facilitate wider implementation of improved organizational arrangements. Similarly, research should identify specific roadblocks to translating evidence into action. These may be structures and processes at the health system level, e.g. availability of professionals with the right skillset, reimbursement mechanisms, and clear organizational intervention implementation guidelines.

Simon de Lusignan, William Hinton, Emmanouela Konstantara, Neil Munro, Martin Whyte, Julie Mount, Michael Feher (2019)Intensification to injectable therapy in type 2 diabetes: mixed methods study (protocol), In: BMC Health Services Research19284pp. 1-10 BMC

Background In the UK, type 2 diabetes mellitus (T2D) is largely managed in primary care. Delay in the intensification to injectable therapy, a form of clinical inertia, is associated with worse glycaemic control. UK general practice is highly computerised, with care being recorded on computerised medical record systems; this allows for quantitative analysis of clinical care but not of the underpinning decision-making process. The aim of this study is to investigate perceptions of patients and clinicians in primary care on the initiation of injectable therapies in T2D, and the context within which those decisions are made. Methods This is a mixed methods study, taking a “realist evaluation” approach. The qualitative components comprise focus groups, interviews, and video recordings of simulated surgeries; the quantitative analysis: an overview of participating practices, elements of the video recording, and an online survey. We will recruit primary care clinicians (general practitioners and nurses) and patients from a representative sample of practices within the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network. Participants will be patients with T2D, and primary care clinicians. Focus groups and semi-structured interviews will be recorded, transcribed verbatim and analysed using Framework Analysis. The simulated surgeries will include cases that might be escalated to injectable therapy. The consultation will be reviewed using the Calgary-Cambridge model to assess communication and determination of adherence to national prescribing guidelines. We will conduct multi-channel video recording including screen capture, clinician and patient facial expressions, wide angle view of the consultation, and the computerised medical record screen. This allows annotation and qualitative analysis of the video recordings, and statistical analyses for the quantitative data. We will also conduct an online survey of primary care clinicians’ attitudes to, and perceptions of, initiation of injectable therapies, which will be analysed using summary statistics. Discussion Results aim to provide a detailed insight into the dynamic two-way decision-making process underpinning use of injectable therapy for T2D. The study will provide insights into clinical practice and enable the development of training, interventions and guidelines that may facilitate, where appropriate, the intensification to injectable therapy.

S De Lusignan, PN Stephens, N Adal, A Majeed (2002)Does feedback improve the quality of computerized medical records in primary care?, In: J Am Med Inform Assoc9(4)pp. 395-401 BMJ

The MediPlus database collects anonymized information from generalpractice computer systems in the United Kingdom, for research purposes. Data quality markers are collated and fed back to the participating general practitioners. The authors examined whether this feedback had a significant effect on data quality.

Harshana Liyanage, Siaw-Teng Liaw, Emmanouela Konstantara, Freda Elizabeth Mold, Richard Schreiber, Craig Kuziemsky, Amanda Terry, Simon de Lusignan (2018)Benefit-risk of Patients' Online Access to their Medical Records: Consensus Exercise of an International Expert Group, In: Yearbook of Medical Informatics27(01)pp. 156-162 Thieme Publishing

Background: Patients' access to their computerised medical records (CMRs) is a legal right in many countries. However, little is reported about the benefit-risk associated with patients' online access to their CMRs. Objective: To conduct a consensus exercise to assess the impact of patients' online access to their CMRs on the quality of care as defined in six domains by the Institute of Medicine (IoM), now the National Academy of Medicine (NAM). Method: A five-round Delphi study was conducted. Round One explored experts' (n = 37) viewpoints on providing patients with access to their CMRs. Round Two rated the appropriateness of statements arising from Round One (n = 16). The third round was an online panel discussion of findings (n = 13) with the members of both the International Medical Informatics Association and the European Federation of Medical Informatics Primary Health Care Informatics Working Groups. Two additional rounds, a survey of the revised consensus statements and an online workshop, were carried out to further refine consensus statements. Results: Thirty-seven responses from Round One were used as a basis to initially develop 15 statements which were categorised using IoM's domains of care quality. The experts agreed that providing patients online access to their CMRs for bookings, results, and prescriptions increased efficiency and improved the quality of medical records. Experts also anticipated that patients would proactively use their online access to share data with different health care providers, including emergencies. However, experts differed on whether access to limited or summary data was more useful to patients than accessing their complete records. They thought online access would change recording practice, but they were unclear about the benefit-risk of high and onerous levels of security. The 5-round process, finally, produced 16 consensus statements. Conclusion: Patients' online access to their CMRs should be part of all CMR systems. It improves the process of health care, but further evidence is required about outcomes. Online access improves efficiency of bookings and other services. However, there is scope to improve many of the processes of care it purports to support, particularly the provision of a more effective interface and the protection of the vulnerable.

Sally Harcourt, Roger A. Morbey, Chris Bates, Helen Carter, Shamez N. Ladhani, Simon de Lusignan, Gillian E. Smith, Alex J. Elliot (2017)Estimating primary care attendance rates for fever in infants after meningococcal B vaccination in England using national syndromic surveillance data, In: Vaccine36(4)pp. 565-571 Elsevier

Background 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. Methods 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. Results 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. Conclusions 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.

William Hinton, Banne Nemeth, Simon de Lusignan, Ben Field, Michael D Feher, Neil Munro, Lara N Roberts, Roopen Arya, Martin B Whyte (2020)Effect of type 1 diabetes and type 2 diabetes on the risk of venous thromboembolism, In: Diabetic medicinepp. e14452-e14452

AIMSWhether diabetes increases venous thromboembolism (VTE) is unclear. Any greater risk may relate to insulin resistance, but many studies did not differentiate between type 1 diabetes and type 2 diabetes for VTE risk. METHODSRetrospective cohort study of the Royal College of General Practitioners Research and Surveillance Centre, comprising over 530 primary care practices. We determined whether type 1 diabetes and/or type 2 diabetes are independent risk factors for VTE. The index date was 1 January 2009, individuals were followed to 31 December 2018, or censoring. Cox proportional hazard regression analysis was used to investigate the risk of VTE in people with type 1 diabetes and type 2 diabetes relative to no diabetes. The primary outcome was occurrence of VTE. The model was adjusted for potential confounders for VTE. RESULTSThere were 7086 people with type 1 diabetes and 95,566 with type 2 diabetes, diagnosed before 1 January 2009. The non-diabetes group consisted of 1,407,699 people. In the unadjusted analysis, there was no increased risk of VTE with type 1 diabetes (HR 1.00, 95% CI 0.76-1.33) but there was for type 2 diabetes (HR 2.70, 95% CI 2.57-2.84). In the fully adjusted model, VTE risk was increased in type 1 diabetes (HR 1.46, 95% CI 1.11-1.92), but not with type 2 diabetes (HR 1.06, 95% CI 0.98-1.14). CONCLUSIONSType 1 diabetes was associated with a greater risk for VTE while type 2 diabetes was not. Further work is needed to determine the reason(s) for this.

M Halter, V Drennan, K Chattopadhyay, W Carneiro, J Yiallouros, Simon de Lusignan, Heather Gage, J Gabe, R Grant (2013)The contribution of Physician Assistants in primary care: a systematic review., In: BMC Health Serv Res13 BioMed Central

Primary care provision is important in the delivery of health care but many countries face primary care workforce challenges. Increasing demand, enlarged workloads, and current and anticipated physician shortages in many countries have led to the introduction of mid-level professionals, such as Physician Assistants (PAs). Objective: This systematic review aimed to appraise the evidence of the contribution of PAs within primary care, defined for this study as general practice, relevant to the UK or similar systems.

AP McGovern, S Jones, J van Vlymen, AK Saggar, R Sandford, S de Lusignan (2014)Identification of people with autosomal dominant polycystic kidney disease using routine data: a cross sectional study., In: BMC Nephrology15 BioMed Central

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) causes progressive renal damage and is a leading cause of end-stage renal failure. With emerging therapies it is important to devise a method for early detection. We aimed to identify factors from routine clinical data which can be used to distinguish people with a high likelihood of having ADPKD in a primary health care setting. METHOD: A cross-sectional study was undertaken using data from the Quality Intervention in Chronic Kidney Disease trial extracted from 127 primary care practices in England. The health records of 255 people with ADPKD were compared to the general population. Logistic regression was used to identify clinical features which distinguish ADPKD. These clinical features were used to stratify individual risk using a risk score tool. RESULTS: Renal impairment, proteinuria, haematuria, a diastolic blood pressure over 90 mmHg and multiple antihypertensive medications were more common in ADPKD than the general population and were used to build a regression model (area under the receiver operating characteristic curve; 0.79). Age, gender, haemoglobin and urinary tract infections were not associated with ADPKD. A risk score (range -3 to +10) of ≥0 gave a sensitivity of 70.2% and specificity 74.9% of for detection. CONCLUSIONS: Stratification of ADPKD likelihood from routine data may be possible. This approach could be a valuable component of future screening programs although further longitudinal analyses are needed.

Irritable bowel syndrome is a common condition in general practice. It occurs in 10 to 20% of the population, but less than half seek medical assistance with the complaint.

Laura Tripkovic, LR Wilson, Kathryn Hart, Sigurd Johnsen, Simon de Lusignan, CP Smith, G Bucca, S Penson, G Chope, Ruan Elliott, E Hypponen, J L Berry, Susan Lanham-New (2017)Daily supplementation with 15 mg vitamin D2 compared with vitamin D3 to increase wintertime 25-hydroxyvitamin D status in healthy South Asian and white European women: a 12-wk randomized, placebo-controlled food-fortification trial, In: American Journal of Clinical Nutrition106(2)pp. 481-490 American Society for Nutrition

Background: There are conflicting views in the literature as to whether vitamin D2 and vitamin D3 are equally effective in increasing and maintaining serum concentrations of 25-hydroxyvitamin D [25(OH)D], particularly at lower doses of vitamin D. Objective: We aimed to investigate whether vitamin D2 or vitamin D3 fortified in juice or food, at a relatively low dose of 15 μg/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 μg vitamin D2, biscuit supplemented with 15 μg vitamin D2, juice supplemented with 15 μg vitamin D3, or biscuit supplemented with 15 μg 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 (Δ) in total 25(OH)D when compared with the vitamin D2 biscuit group [Δ (95% CI): 15.3 nmol/L (7.4, 23.3 nmol/L) (P < 0.0003) and 16.0 nmol/L (8.0, 23.9 nmol/L) ( P < 0.0001)], the vitamin D2 juice group [Δ (95% CI): 16.3 nmol/L (8.4, 24.2 nmol/L) (P < 0.0001) and 16.9 nmol/L (9.0, 24.8 nmol/L) (P < 0.0001)], and the placebo group [Δ (95% CI): 42.3 nmol/L (34.4, 50.2 nmol/L) (P < 0.0001) and 42.9 nmol/L (35.0, 50.8 nmol/L) (P < 0.0002)]. Conclusions: With the use of a daily dose of vitamin D relevant to public health recommendations (15 μg) 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.

AP McGovern, W Hinton, J van Vlymen, N Munro, M Whyte, S de Lusignan (2016)Real-world evidence on the disparities in prescribing of dipeptidylpeptidase-4 inhibitors in UK primary care, In: DIABETIC MEDICINE33pp. 183-183 WILEY-BLACKWELL
JRW Brownrigg, CO Hughes, D Burleigh, A Karthikesalingam, BO Patterson, PJ Holt, MM Thompson, S de Lusignan, KK Ray, RJ Hinchliffe (2016)Microvascular disease and risk of cardiovascular events among individuals with type 2 diabetes: a population-level cohort study, In: The Lancet Diabetes & Endocrinology4(7)pp. 588-597 Elsevier

Background 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. Methods 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

Diabetes mellitus (DM) is a serious, chronic condition affecting 2.3 million people in the UK and consuming over 5% of the total National Health Service (NHS) budget. The World Health Organization (WHO) has produced a classification of diabetes which should help ensure consistent diagnosis and management of cases. However, recent quality based targets for diabetes in the UK only allow for people with Type 1 or Type 2 diabetes to be included in the disease register.

T Chan, S de Lusignan, A Cooper, M Elliott (2015)Improving Osteoporosis Management in Primary Care: An Audit of the Impact of a Community Based Fracture Liaison Nurse, In: PLOS ONE10(8)ARTN e0132 PUBLIC LIBRARY SCIENCE
P Kumarapeli, R Stepaniuk, S de Lusignan, R Williams, G Rowlands (2006)Ethnicity recording in general practice computer systems, In: JOURNAL OF PUBLIC HEALTH28(3)pp. 283-287 OXFORD UNIV PRESS
AP Mcgovern, W Hinton, J van Vlymen, N Munro, M Whyte, S de Lusignan (2016)Real-world evidence on prescribing trends in sodium glucose cotransporter 2 inhibitors in UK primary care, In: DIABETIC MEDICINE33pp. 165-165 WILEY-BLACKWELL
W Hinton, AP McGovern, J van Vlymen, N Munro, M Whyte, S Jones, S de Lusignan (2016)Poor glycaemic control is associated with higher serum triglyceride levels in clinical practice, In: DIABETIC MEDICINE33pp. 157-157 WILEY-BLACKWELL
P Kumarapeli, Simon de Lusignan, T Ellis, B Jones (2009)Using Unified Modelling Language (UML) as a process-modelling technique for clinical-research process improvement, In: MEDICAL INFORMATICS AND THE INTERNET IN MEDICINE32(1)pp. 51-64 TAYLOR & FRANCIS LTD

The Primary Care Data Quality programme (PCDQ) is a quality-improvement programme which processes routinely collected general practice computer data. Patient data collected from a wide range of different brands of clinical computer systems are aggregated, processed, and fed back to practices in an educational context to improve the quality of care. Process modelling is a well-established approach used to gain understanding and systematic appraisal, and identify areas of improvement of a business process. Unified modelling language (UML) is a general purpose modelling technique used for this purpose. We used UML to appraise the PCDQ process to see if the efficiency and predictability of the process could be improved. Activity analysis and thinking-aloud sessions were used to collect data to generate UML diagrams. The UML model highlighted the sequential nature of the current process as a barrier for efficiency gains. It also identified the uneven distribution of process controls, lack of symmetric communication channels, critical dependencies among processing stages, and failure to implement all the lessons learned in the piloting phase. It also suggested that improved structured reporting at each stage-especially from the pilot phase, parallel processing of data and correctly positioned process controls-should improve the efficiency and predictability of research projects. Process modelling provided a rational basis for the critical appraisal of a clinical data processing system; its potential maybe underutilized within health care. © 2007 Informa UK Ltd All rights reserved.

Many practices in the UK have computerised information dating back to the 1990s. These health records provide contemporaneous collected longitudinal data for analysis of health trends and their management in primary care over time.

Andrew Mcgovern, Z Tippu, William Hinton, N Munro, Martin Whyte, Simon de Lusignan (2017)Comparison of medication adherence and persistence in type 2 diabetes: A systematic review and meta-analysis, In: Diabetes, Obesity and Metabolism20(4)pp. 1040-1043 Wiley

Limited medication adherence and persistence with treatment are barriers to successful 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.

Vari M Drennan, Mary Halter, Carly Wheeler, Laura Nice, Sally Brearley, James Ennis, Jonathan Gabe, Heather Gage, Ros Levenson, Simon de Lusignan, Phil Begg, James Parle (2019)What is the contribution of physician associates in hospital care in England? A mixed methods, multiple case study, In: BMJ Open9(1)e027012pp. 1-9 BMJ Publishing Group

Objectives To investigate the deployment of physician associates (PAs); the factors supporting and inhibiting their employment and their contribution and impact on patients’ experience and outcomes and the organisation of services. Design Mixed methods within a case study design, using interviews, observations, work diaries and documentary analysis. Setting Six acute care hospitals in three regions of England in 2016–2017. Participants 43 PAs, 77 other health professionals, 28 managers, 28 patients and relatives. Results A key influencing factor supporting the employment of PAs in all settings was a shortage of doctors. PAs were found to be acceptable, appropriate and safe members of the medical/surgical teams by the majority of doctors, managers and nurses. They were mainly deployed to undertake inpatient ward work in the medical/surgical team during core weekday hours. They were reported to positively contribute to: continuity within their medical/surgical team, patient experience and flow, inducting new junior doctors, supporting the medical/surgical teams’ workload, which released doctors for more complex patients and their training. The lack of regulation and attendant lack of authority to prescribe was seen as a problem in many but not all specialties. The contribution of PAs to productivity and patient outcomes was not quantifiable separately from other members of the team and wider service organisation. Patients and relatives described PAs positively but most did not understand who and what a PA was, often mistaking them for doctors. Conclusions This study offers new insights concerning the deployment and contribution of PAs in medical and surgical specialties in English hospitals. PAs provided a flexible addition to the secondary care workforce without drawing from existing professions. Their utility in the hospital setting is unlikely to be completely realised without the appropriate level of regulation and authority to prescribe medicines and order ionising radiation within their scope of practice.

Samad Ansari, Simon de Lusignan, William Hinton, N Munro, Simon Taylor, Andrew Peter Mcgovern (2018)Glycemic control is an important modifiable risk factor for uveitis in patients with diabetes: A retrospective cohort study establishing clinical risk and ophthalmic disease burden., In: Journal of Diabetes and Its Complications32(6)pp. 602-608 Elsevier

Aim To characterize the risk uveitis, scleritis or episcleritis in relation to diabetes, glycaemic control, and co-existence of retinopathy. Methods 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. Results 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 

Simon de Lusignan, Christopher McGee, Rebecca Webb, Mark Joy, Rachel Byford, Ivelina Yonova, Mariya Hriskova, Filipa Ferreira, Alex J Elliot, Gillian Smith, Imran Rafi (2018)Conurbation, Urban, and Rural Living as Determinants of Allergies and Infectious Diseases: Royal College of General Practitioners Research and Surveillance Centre Annual Report 2016-2017, In: JMIR Public Health and Surveillance4(4)e11354 JMIR Publications

Background: Living in a conurbation, urban, or rural environment is an important determinant of health. For example, conurbation and rural living is associated with increased respiratory and allergic conditions, whereas a farm or rural upbringing has been shown to be a protective factor against this. Objective: The objective of the study was to assess differences in general practice presentations of allergic and infectious disease in those exposed to conurbation or urban living compared with rural environments. Methods: The population was a nationally representative sample of 175 English general practices covering a population of over 1.6 million patients registered with sentinel network general practices. General practice presentation rates per 100,000 population were reported for allergic rhinitis, asthma, and infectious conditions grouped into upper and lower respiratory tract infections, urinary tract infection, and acute gastroenteritis by the UK Office for National Statistics urban-rural category. We used multivariate logistic regression adjusting for age, sex, ethnicity, deprivation, comorbidities, and smoking status, reporting odds ratios (ORs) with 95% CIs. Results: For allergic rhinitis, the OR was 1.13 (95% CI 1.04-1.23; P=.003) for urban and 1.29 (95% CI 1.19-1.41; P

A McGovern, W Hinton, J van Vlymen, N Munro, MB Whyte, S de Lusignan (2016)Real world evidence on prescribing trends in sodium glucose co-transporter 2 inhibitors in UK primary care, In: Diabetic Medicine, Volume 33, Issue Supplement S1, March 2016 Special Issue: Abstracts of the Diabetes UK Professional Conference 201633(Supple)pp. 165-165

Aims: The sodium glucose cotransporter 2 (SGLT2) inhibitors are a 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.

Mary Halter, Carly Wheeler, Ferruccio Pelone, Heather Gage, Simon de Lusignan, Jim Parle, Robert Grant, Jonathan Gabe, Laura Nice, Vari M Drennan (2018)Contribution of physician assistants/associates to secondary care: a systematic review, In: BMJ Open8(6)e019573pp. e019573-1 BMJ Publishing Group

Objective 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. Design Systematic review. Setting Electronic databases (Medline, Embase, ASSIA, CINAHL, SCOPUS, PsycINFO, Social Policy and Practice, EconLit and Cochrane), reference lists and related articles. Included articles Peer-reviewed articles of any study design, published in English, 1995–2017. Interventions Blinded parallel processes were used to screen abstracts and full text, data extractions and quality assessments against published guidelines. A narrative synthesis was undertaken. Outcome measures Impact on: patients’ experiences and outcomes, service organisation, working practices, other professional groups and costs. Results 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. Conclusions 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.

Simone Wahl, Alexander Drong, Benjamin Lehne, Marie Loh, William R. Scott, Sonja Kunze, Pei-Chien Tsai, Janina S. Ried, Weihua Zhang, Youwen Yang, Sili Tan, Giovanni Fiorito, Lude Franke, Simonetta Guarrera, Silva Kasela, Jennifer Kriebel, Rebecca C. Richmond, Marco Adamo, Uzma Afzal, Mika Ala-Korpela, Benedetta Albetti, Ole Ammerpohl, Jane F. Apperley, Marian Beekman, Pier Alberto Bertazzi, S. Lucas Black, Christine Blancher, Marc-Jan Bonder, Mario Brosch, Maren Carstensen-Kirberg, Anton J. M. de Craen, Simon de Lusignan, Abbas Dehghan, Mohamed Elkalaawy, Krista Fischer, Oscar H. Franco, Tom R. Gaunt, Jochen Hampe, Majid Hashemi, Aaron Isaacs, Andrew Jenkinson, Sujeet Jha, Norihiro Kato, Vittorio Krogh, Michael Laffan, Christa Meisinger, Thomas Meitinger, Zuan Yu Mok, Valeria Motta, Hong Kiat Ng, Zacharoula Nikolakopoulou, Georgios Nteliopoulos, Salvatore Panico, Natalia Pervjakova, Holger Prokisch, Wolfgang Rathmann, Michael Roden, Federica Rota, Michelle Ann Rozario, Johanna K. Sandling, Clemens Schafmayer, Katharina Schramm, Reiner Siebert, P. Eline Slagboom, Pasi Soininen, Lisette Stolk, Konstantin Strauch, E-Shyong Tai, Letizia Tarantini, Barbara Thorand, Ettje F. Tigchelaar, Rosario Tumino, Andre G. Uitterlinden, Cornelia van Duijn, Joyce B. J. van Meurs, Paolo Vineis, Ananda Rajitha Wickremasinghe, Cisca Wijmenga, Tsun-Po Yang, Wei Yuan, Alexandra Zhernakova, Rachel L. Batterham, George Davey Smith, Panos Deloukas, Bastiaan T. Heijmans, Christian Herder, Albert Hofman, Cecilia M. Lindgren, Lili Milani, Pim van der Harst, Annette Peters, Thomas Illig, Caroline L. Relton, Melanie Waldenberger, Marjo-Riitta Järvelin, Valentina Bollati, Richie Soong, Tim D. Spector, James Scott, Mark I. McCarthy, Paul Elliott, Jordana T. Bell, Giuseppe Matullo, Christian Gieger, Jaspal S. Kooner, Harald Grallert, John C. Chambers (2016)Epigenome-wide association study of body mass index, and the adverse outcomes of adiposity, In: Nature541(7635)pp. 81-86 Macmillan Publishers Limited, part of Springer Nature

Approximately 1.5 billion people worldwide are overweight or affected by obesity, and are at risk of developing type 2 diabetes, cardiovascular disease and related metabolic and inflammatory disturbances1,2. Although the mechanisms linking adiposity to associated clinical conditions are poorly understood, recent studies suggest that adiposity may influence DNA methylation3,4,5,6, 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 

L.H. Rayner, A.P. Mcgovern, J. Sherlock, P. Gatenby, A. Correa, B. Creagh-Brown, S. de Lusignan (2018)Type 2 diabetes: A protective factor for COPD?, In: Primary Care Diabetes12(5)pp. 438-444 Elsevier Ltd

Background Chronic obstructive pulmonary disease (COPD) and type 2 diabetes (T2DM) are common comorbidities. COPD is a known risk factor for incident T2DM, however few studies have examined the relationship in reverse. The primary aim of this study was to compare the incidence of COPD in people with and without T2DM. Materials and methods We conducted a retrospective case-control study using a long-established English general practice network database (n = 894,646). We matched 29,217 cases of T2DM with controls, adjusting for age, gender, smoking status, BMI and social deprivation, to achieve 1:1 propensity matching and compared the rate of incident COPD over eight years of follow-up. We performed a secondary analysis to investigate the effect of insulin, metformin and sulphonylureas on COPD incidence. Results People with T2DM had a reduced risk of COPD compared to matched controls over the follow-up period (HR 0.89, 95%CI 0.79–0.93). 48.5% of those with T2DM were ex-smokers compared with 27.3% of those without T2DM. Active smoking rates were 20.4% and 23.7% respectively. Insulin, metformin and sulphonylureas were not associated with incident COPD. Conclusions People with T2DM are less likely to be diagnosed with COPD than matched controls. This may be due to positive lifestyle changes, such as smoking cessation in those with T2DM.

Andrew Mcgovern, William Hinton, Ana Correa, N Munro, Martin Whyte, Simon de Lusignan (2016)Real world evidence studies into treatment adherence, thresholds for intervention, and disparities in treatment, in people with Type 2 Diabetes in the UK, In: BMJ Open6(11)e012801 BMJ Journals

Purpose The University of Surrey-Lilly Real World Evidence (RWE) diabetes cohort has been established to provide insights into the management of type 2 diabetes mellitus (T2DM). There are 3 areas of study due to be conducted to provide insights into T2DM management: exploration of medication adherence, thresholds for changing diabetes therapies, and ethnicity-related or socioeconomic-related disparities in management. This paper describes the identification of a cohort of people with T2DM which will be used for these analyses, through a case finding algorithm, and describes the characteristics of the identified cohort. Participants A cohort of people with T2DM was identified from the Royal College of General Practitioners Research and Surveillance Centre (RCGP RSC) data set. This data set comprises electronic patient records collected from a nationally distributed sample of 130 primary care practices across England with scope to increase the number of practices to 200. Findings to date A cohort (N=58 717) of adults with T2DM was identified from the RCGP RSC population (N=1 260 761), a crude prevalence of diabetes of 5.8% in the adult population. High data quality within the practice network and an ontological approach to classification resulted in a high level of data completeness in the T2DM cohort; ethnicity identification (82.1%), smoking status (99.3%), alcohol use (93.3%), glycated haemoglobin (HbA1c; 97.9%), body mass index (98.0%), blood pressure (99.4%), cholesterol (87.4%) and renal function (97.8%). Data completeness compares favourably to other, similarly large, observational cohorts. The cohort comprises a distribution of ages, socioeconomic and ethnic backgrounds, diabetes complications, and comorbidities, enabling the planned analyses. Future plans Regular data uploads from the RCGP RSC practice network will enable this cohort to be followed prospectively. We will investigate medication adherence, explore thresholds and triggers for changing diabetes therapies, and investigate any ethnicity-related or socioeconomic-related disparities in diabetes management.

F Mold, S de Lusignan, A Sheikh, A Majeed, JC Wyatt, T Quinn, M Cavill, C Franco, U Chauhan, H Blakey, N Kataria, TN Arvanitis, B Ellis (2015)Patients' online access to their electronic health records and linked online services: a systematic review in primary care, In: BRITISH JOURNAL OF GENERAL PRACTICE65(632)ARTN e141 ROYAL COLL GENERAL PRACTITIONERS
AP McGovern, B Rusholme, S Jones, JN van Vlyman, H Liyanage, H Gallagher, CR Tomson, K Khunti, K Harris, S de Lusignan (2013)Association of chronic kidney disease (CKD) and failure to monitor renal function with adverse outcomes in people with diabetes: A primary care cohort study., In: BMC Nephrol14(1) BioMed Central

Chronic kidney disease (CKD) is a known risk factor for cardiovascular events and all-cause mortality. We investigate the relationship between CKD stage, proteinuria, hypertension and these adverse outcomes in the people with diabetes. We also study the outcomes of people who did not have monitoring of renal function.

R Pebody, F Warburton, J Ellis, N Andrews, A Potts, S Cottrell, J Johnston, A Reynolds, R Gunson, C Thompson, M Galiano, C Robertson, R Byford, N Gallagher, M Sinnathamby, I Yonova, S Pathirannehelage, M Donati, C Moore, S de Lusignan, J McMenamin, M Zambon (2016)Effectiveness of seasonal influenza vaccine for adults and children in preventing laboratory-confirmed influenza in primary care in the United Kingdom: 2015/16 end-of-season results, In: Eurosurveillance21(38) European Centre for Disease Prevention and Control

The United Kingdom (UK) is in the third season of introducing universal paediatric influenza vaccination with a quadrivalent live attenuated influenza vaccine (LAIV). The 2015/16 season in the UK was initially dominated by influenza A(H1N1)pdm09 and then influenza of B/Victoria lineage, not contained in that season’s adult trivalent inactivated influenza vaccine (IIV). Overall adjusted end-of-season vaccine effectiveness (VE) was 52.4% (95% confidence interval (CI): 41.0–61.6) against influenza-confirmed primary care consultation, 54.5% (95% CI: 41.6–64.5) against influenza A(H1N1)pdm09 and 54.2% (95% CI: 33.1–68.6) against influenza B. In 2–17 year-olds, adjusted VE for LAIV was 57.6% (95% CI: 25.1 to 76.0) against any influenza, 81.4% (95% CI: 39.6–94.3) against influenza B and 41.5% (95% CI: −8.5 to 68.5) against influenza A(H1N1)pdm09. These estimates demonstrate moderate to good levels of protection, particularly against influenza B in children, but relatively less against influenza A(H1N1)pdm09. Despite lineage mismatch in the trivalent IIV, adults younger than 65 years were still protected against influenza B. These results provide reassurance for the UK to continue its influenza immunisation programme planned for 2016/17.

Emily Jennings, Simon de Lusignan, Georgios Michalakidis, Paul Krause, Frank Sullivan, Harshana Liyanage, Brendan C. Delaney (2018)An instrument to identify computerised primary care research networks, genetic and disease registries prepared to conduct linked research: TRANSFoRm International Research Readiness (TIRRE) survey, In: Journal of Innovation in Health Informatics25 BCS, The Chartered Institute for IT

Purpose The Translational Research and Patients safety in Europe (TRANSFoRm) project aims to integrate primary care with clinical research whilst improving patient safety. The TRANSFoRm International Research Readiness survey (TIRRE) aims to demonstrate data use through two linked data studies and by identifying clinical data repositories and genetic databases or disease registries prepared to participate in linked research. Method The TIRRE survey collects data at micro-, meso- and macro-levels of granularity; to fulfil data, study specific, business, geographical and readiness requirements of potential data providers for the TRANSFoRm demonstration studies. We used descriptive statistics to differentiate between demonstration-study compliant and non-compliant repositories. We only included surveys with >70% of questions answered in our final analysis, reporting the odds ratio (OR) of positive responses associated with a demonstration-study compliant data provider. Results We contacted 531 organisations within the Eurpean Union (EU). Two declined to supply information; 56 made a valid response and a further 26 made a partial response. Of the 56 valid responses, 29 were databases of primary care data, 12 were genetic databases and 15 were cancer registries. The demonstration compliant primary care sites made 2098 positive responses compared with 268 in non-use-case compliant data sources [OR: 4.59, 95% confidence interval (CI): 3.93–5.35, p < 0.008]; for genetic databases: 380:44 (OR: 6.13, 95% CI: 4.25–8.85, p < 0.008) and cancer registries: 553:44 (OR: 5.87, 95% CI: 4.13–8.34, p < 0.008).Conclusions TIRRE comprehensively assesses the preparedness of data repositories to participate in specific research projects. Multiple contacts about hypothetical participation in research identified few potential sites.

A McGovern, M Rafiq, N Munro, L Butler, D Russell-Jones, S Jones, R Hinchcliffe, S de Lusignan (2017)Peripheral Sensory Neuropathy is a Predictor of Mortality in People with Diabetes

The 10g monofilament test is a simple method of detecting the presence of sensory neuropathy widely used by non-specialists; and included in pay-for-performance indicators for UK primary care. However, the association with increased mortality has not previously been explored. 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 < 0.001). The association between mortality and sensory neuropathy was stronger than that with elevated HbA1c (OR 1.16; 95% CI 1.01-1.34; p = 0.037), and comparable to smoking, ischaemic heart disease, heart failure, and dyslipidaemia. Failure to monitor sensation using monofilament testing was also associated with an increased risk of mortality: OR 1.23 (95% CI 1.08-1.40; p = 0.002). The receiver operating characteristic (ROC) statistic for the model was 0.84. 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.

S de Lusignan, C van Weel (2006)The use of routinely collected computer data for research in primary care: opportunities and challenges., In: Fam Pract23(2)pp. 253-263 Oxford University Press

INTRODUCTION: Routinely collected primary care data has underpinned research that has helped define primary care as a specialty. In the early years of the discipline, data were collected manually, but digital data collection now makes large volumes of data readily available. Primary care informatics is emerging as an academic discipline for the scientific study of how to harness these data. This paper reviews how data are stored in primary care computer systems; current use of large primary care research databases; and, the opportunities and challenges for using routinely collected primary care data in research. OPPORTUNITIES: (1) Growing volumes of routinely recorded data. (2) Improving data quality. (3) Technological progress enabling large datasets to be processed. (4) The potential to link clinical data in family practice with other data including genetic databases. (5) An established body of know-how within the international health informatics community. CHALLENGES: (1) Research methods for working with large primary care datasets are limited. (2) How to infer meaning from data. (3) Pace of change in medicine and technology. (4) Integrating systems where there is often no reliable unique identifier and between health (person-based records) and social care (care-based records-e.g. child protection). (5) Achieving appropriate levels of information security, confidentiality, and privacy. CONCLUSION: Routinely collected primary care computer data, aggregated into large databases, is used for audit, quality improvement, health service planning, epidemiological study and research. However, gaps exist in the literature about how to find relevant data, select appropriate research methods and ensure that the correct inferences are drawn.

Agnieszka Lemanska, Rachel C. Byford, Clare Cruickshank, David P. Dearnaley, Filipa Ferreira, Clare Griffin, Emma Hall, William Hinton, Simon de Lusignan, Julian Sherlock, Sara Faithfull (2020)Linkage of the CHHiP randomised controlled trial with primary care data: a study investigating ways of supplementing cancer trials and improving evidence-based practice, In: BMC Medical Research Methodology20(198) BMC

Background Randomised controlled trials (RCTs) are the gold standard for evidence-based practice. However, RCTs can have limitations. For example, translation of findings into practice can be limited by design features, such as inclusion criteria, not accurately reflecting clinical populations. In addition, it is expensive to recruit and follow-up participants in RCTs. Linkage with routinely collected data could offer a cost-effective way to enhance the conduct and generalisability of RCTs. The aim of this study is to investigate how primary care data can support RCTs. Methods Secondary analysis following linkage of two datasets: 1) multicentre CHHiP radiotherapy trial (ISRCTN97182923) and 2) primary care database from the Royal College of General Practitioners Research and Surveillance Centre. Comorbidities and medications recorded in CHHiP at baseline, and radiotherapy-related toxicity recorded in CHHiP over time were compared with primary care records. The association of comorbidities and medications with toxicity was analysed with mixed-effects logistic regression. Results Primary care records were extracted for 106 out of 2811 CHHiP participants recruited from sites in England (median age 70, range 44 to 82). Complementary information included longitudinal body mass index, blood pressure and cholesterol, as well as baseline smoking and alcohol usage but was limited by the considerable missing data. In the linked sample, 9 (8%) participants were recorded in CHHiP as having a history of diabetes and 38 (36%) hypertension, whereas primary care records indicated incidence prior to trial entry of 11 (10%) and 40 (38%) respectively. Concomitant medications were not collected in CHHiP but available in primary care records. This indicated that 44 (41.5%) men took aspirin, 65 (61.3%) statins, 14 (13.2%) metformin and 46 (43.4%) phosphodiesterase-5-inhibitors at some point before or after trial entry. Conclusions We provide a set of recommendations on linkage and supplementation of trials. Data recorded in primary care are a rich resource and linkage could provide near real-time information to supplement trials and an efficient and cost-effective mechanism for long-term follow-up. In addition, standardised primary care data extracts could form part of RCT recruitment and conduct. However, this is at present limited by the variable quality and fragmentation of primary care data.

VM Drennan, M Halter, S Brearley, W Carneiro, J Gabe, Heather Gage, R Grant, L Joly, Simon de Lusignan (2014)Investigating the contribution of physician assistants to primary care in England: a mixed-methods study, In: Health Services and Delivery Research2(16) NIHR Journals Library

Background: Primary health care is changing as it responds to demographic shifts, technological changes and fiscal constraints. This, and predicted pressures on medical and nursing workforces, raises questions about staffing configurations. Physician assistants (PAs) are mid-level practitioners, trained in a medical model over 2 years at postgraduate level to work under a supervising doctor. A small number of general practices in England have employed PAs. Objective: To investigate the contribution of PAs to the delivery of patient care in primary care services in England. Design: A mixed-methods study conducted at macro, meso and micro organisational levels in two phases: (1) a rapid review, a scoping survey of key national and regional informants, a policy review, and a survey of PAs and (2) comparative case studies in 12 general practices (six employing PAs). The latter incorporated clinical record reviews, a patient satisfaction survey, video observations of consultations and interviews with patients and professionals. Results: The rapid review found 49 published studies, mainly from the USA, which showed increased numbers of PAs in general practice settings but weak evidence for impact on processes and patient outcomes. The scoping survey found mainly positive or neutral views about PAs, but there was no mention of their role in workforce policy and planning documents. The survey of PAs in primary care (n = 16) found that they were mainly deployed to provide same-day appointments. The comparative case studies found that physician assistants were consulted by a wide range of patients, but these patients tended to be younger, with less medically acute or complex problems than those consulting general practitioners (GPs). Patients reported high levels of satisfaction with both PAs and GPs. The majority were willing or very willing to consult a PA again but wanted choice in which type of professional they consulted. There was no significant difference between PAs and GPs in the primary outcome of patient reconsultation for the same problem within 2 weeks, investigations/tests ordered, referrals to secondary care or prescriptions issued. GPs, blinded to the type of clinician, judged the documented activities in the initial consultation of patients who reconsulted for the same problem to be appropriate in 80% (n = 223) PA and 50% (n = 252) GP records. PAs were judged to be competent and safe from observed consultations. The average consultation with a physician assistant is significantly longer than that with a GP: 5.8 minutes for patients of average age for this sample (38 years). Costs per consultation were £34.36 for GPs and £28.14 for PAs. Costs could not be apportioned to GPs for interruptions, supervision or training of PAs.Conclusions: PAs were found to be acceptable, effective and efficient in complementing the work of GPs. PAs can provide a flexible addition to the primary care workforce. They offer another labour pool to consider in health professional workforce and education planning at local, regional and national levels. However, in order to maximise the contribution of PAs in primary care settings, consideration needs to be given to the appropriate level of regulation and the potential for authority to prescribe medicines. Future research is required to investigate the contribution of PAs to other first contact services as well as secondary services; the contribution and impact of all types of mid-level practitioners (including nurse practitioners) in first contact services; the factors and influences on general practitioner and practice manager decision-making as to staffing and skill mix; and the reliability and validity of classification systems for both primary care patients and their presenting condition and their consequences for health resource utilisation.

S Clement, A Pickering, G Rowlands, K Thiru, B Candy, S De Lusignan (2000)Towards a conceptual framework for evaluating primary care research networks, In: BRITISH JOURNAL OF GENERAL PRACTICE50(457)pp. 651-652 ROYAL COLL GENERAL PRACTITIONERS
Agnieszka Lemanska, Sara Faithfull, Harshana Liyanage, Sophie Otter, Marina Romanchikova, Julian Sherlock, Nadia Smith, Spencer Thomas, Simon de Lusignan (2020)Primary Care Prostate Cancer Case Ascertainment, In: Studies in health technology and informatics270pp. 1369-1370 IOS Press

Although routine healthcare data are not collected for research, they are increasingly used in epidemiology and are key real-world evidence for improving healthcare. This study presents a method to identify prostate cancer cases from a large English primary care database. 19,619 (1.3%) men had a code for prostate cancer diagnosis. Codes for medium and high Gleason grading enabled identification of additional 94 (0.5%) cases. Many studies do not report codes used to identify patients, and if published, the lists of codes differ from study to study. This can lead to poor research reproducibility and hinder validation. This work demonstrates that carefully developed comprehensive lists of clinical codes can be used to identify prostate cancer; and that approaches that do not solely rely on clinical codes such as ontologies or data linkage should also be considered.

H Gallagher, S de Lusignan, K Harris, C Cates (2010)Quality-improvement strategies for the management of hypertension in chronic kidney disease in primary care: a systematic review., In: Br J Gen Pract60(575)pp. e258-e265

Chronic kidney disease (CKD) is a relatively recently recognised condition. People with CKD are much more likely to suffer from cardiovascular events than progress to established renal failure. Controlling systolic blood pressure should slow the progression of disease and reduce mortality and morbidity. However, no systematic review has been conducted to explore the effectiveness of quality-improvement interventions to lower blood pressure in people with CKD.

S de Lusignan, T Chan, A Theadom, N Dhoul (2007)The roles of policy and professionalism in the protection of processed clinical data: A literature review, In: INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS76(4)pp. 261-268 ELSEVIER IRELAND LTD
Freda Elizabeth Mold, Mary Raleigh, Nouf Shaal Alharbi, Simon de Lusignan (2018)The impact of patient online access to computerized medical records (CMR) and services for Type 2 Diabetes: systematic review., In: Journal of Medical Internet Research20(7)e235 Journal of Medical Internet Research

Background: Online access to computerized medical records has the potential to improve convenience, satisfaction, and care for patients, and to facilitate more efficient organization and delivery of care. Objective: The objective of this review is to explore the use and impact of having online access to computerized medical records and services for patients with type 2 diabetes mellitus in primary care. Methods: Multiple international databases including Medline, Embase, CINAHL, PsycINFO and the Cochrane Library were searched between 2004 and 2016. No limitations were placed on study design, though we applied detailed inclusion and exclusion criteria to each study. Thematic analysis was used to synthesize the evidence. The Mixed Methods Appraisal Toolkit was used to appraise study quality. Results: A search identified 917 studies, of which 28 were included. Five themes were identified: (1) disparities in uptake by age, gender, ethnicity, educational attainment, and number of comorbidities, with young men in full-time employment using these services most; (2) improved health outcomes: glycemic control was improved, but blood pressure results were mixed; (3) self-management support from improved self-care and shared management occurred especially soon after diagnosis and when complications emerged. There was a generally positive effect on physician-patient relationships; (4) accessibility: patients valued more convenient access when online access to computerized medical records and services work; and (5) technical challenges, barriers to use, and system features that impacted patient and physician use. The Mixed Methods Appraisal Toolkit rated 3 studies as 100%, 19 studies as 75%, 4 studies as 50%, and 1 study scored only 25%. Conclusions: Patients valued online access to computerized medical records and services, although in its current state of development it may increase disparities. Online access to computerized medical records appears to be safe and is associated with improved glycemic control, but there was a lack of rigorous evidence in terms of positive health outcomes for other complications, such as blood pressure. Patients remain concerned about how these systems work, the rules, and timeliness of using these systems.

Metadata is data that describes other data or resources. It has a defined number of named elements that convey meaning. Medical data are complex to process. For example, in the Primary Care Data Quality (PCDQ) renal programme, we need to collect over 300 variables because there are so many possible causes of renal disease. These variables are not just single columns of data--all are extracted as code plus date, while others are code-date-value. Metadata has the potential to improve the reliability of processing large datasets.

N Munro, M Bewick, S Jones, S de Lusignan (2014)http://careers.bmj.com/careers/advice/view-article.html?id=20018623, In: BMJ CareersOnline BMJ Careers
W Hinton, A McGovern, J van Vlymen, N Munro, MB Whyte, S de Lusignan (2016)Real world evidence on the prescribing trends of glucagon-like peptide-1 agonists in UK primary care, In: Diabetic Medicine, Volume 33, Issue Supplement S1, March 2016 Special Issue: Abstracts of the Diabetes UK Professional Conference 201633(Supple)pp. 165-165

Aim 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.

ST Liaw, A Rahimi, P Ray, J Taggart, S Dennis, Simon de Lusignan, B Jalaludin, AE Yeo, A Talaei-Khoei (2012)Towards an ontology for data quality in integrated chronic disease management: A realist review of the literature., In: Int J Med Inform82pp. 10-24 Elsevier

PURPOSE: Effective use of routine data to support integrated chronic disease management (CDM) and population health is dependent on underlying data quality (DQ) and, for cross system use of data, semantic interoperability. An ontological approach to DQ is a potential solution but research in this area is limited and fragmented. OBJECTIVE: Identify mechanisms, including ontologies, to manage DQ in integrated CDM and whether improved DQ will better measure health outcomes. METHODS: A realist review of English language studies (January 2001-March 2011) which addressed data quality, used ontology-based approaches and is relevant to CDM. RESULTS: We screened 245 papers, excluded 26 duplicates, 135 on abstract review and 31 on full-text review; leaving 61 papers for critical appraisal. Of the 33 papers that examined ontologies in chronic disease management, 13 defined data quality and 15 used ontologies for DQ. Most saw DQ as a multidimensional construct, the most used dimensions being completeness, accuracy, correctness, consistency and timeliness. The majority of studies reported tool design and development (80%), implementation (23%), and descriptive evaluations (15%). Ontological approaches were used to address semantic interoperability, decision support, flexibility of information management and integration/linkage, and complexity of information models. CONCLUSION: DQ lacks a consensus conceptual framework and definition. DQ and ontological research is relatively immature with little rigorous evaluation studies published. Ontology-based applications could support automated processes to address DQ and semantic interoperability in repositories of routinely collected data to deliver integrated CDM. We advocate moving to ontology-based design of information systems to enable more reliable use of routine data to measure health mechanisms and impacts.

G Michalakidis, P Kumarapeli, A Ring, J van Vlymen, P Krause, S de Lusignan (2010)A system for solution-orientated reporting of errors associated with the extraction of routinely collected clinical data for research and quality improvement., In: Studies in Health Technology and Informatics: Proceedings of the 13th World Congress on Medical Informatics160(Pt 1)pp. 724-728

We have used routinely collected clinical data in epidemiological and quality improvement research for over 10 years. We extract, pseudonymise and link data from heterogeneous distributed databases; inevitably encountering errors and problems.

W Hinton, A McGovern, J van Vlymen, N Munro, MB Whyte, S de Lusignan (2016)Poor glycaemic control is associated with higher serum triglyceride levels in clinical practice, In: Diabetic Medicine, Volume 33, Issue Supplement S1, March 2016 Special Issue: Abstracts of the Diabetes UK Professional Conference 201633(Supple)pp. 157-157

Aims: The relationship between glycaemic control and lipid 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

S de Lusignan, J Cashman, N Poh, G Michalakidis, A Mason, T Desombre, P Krause (2012)Conducting Requirements Analyses for Research using Routinely Collected Health Data: a Model Driven Approach., In: Stud Health Technol Inform180pp. 1105-1107

Background: Medical research increasingly requires the linkage of data from different sources. Conducting a requirements analysis for a new application is an established part of software engineering, but rarely reported in the biomedical literature; and no generic approaches have been published as to how to link heterogeneous health data. Methods: Literature review, followed by a consensus process to define how requirements for research, using, multiple data sources might be modeled. Results: We have developed a requirements analysis: i-ScheDULEs - The first components of the modeling process are indexing and create a rich picture of the research study. Secondly, we developed a series of reference models of progressive complexity: Data flow diagrams (DFD) to define data requirements; unified modeling language (UML) use case diagrams to capture study specific and governance requirements; and finally, business process models, using business process modeling notation (BPMN). Discussion: These requirements and their associated models should become part of research study protocols.

S de Lusignan, SE Wells, NJ Hague, K Thiru (2003)Managers see the problems associated with coding clinical data as a technical issue whilst clinicians also see cultural barriers., In: Methods of Information in Medicine42(4)pp. 416-422 Schattauer

In UK general practice, the coding of clinical data (Read Coding) is far from universal. This study set out to examine the barriers to recording structured information in computerised medical records; and to explore whether managers and clinicians had different perspectives in how these barriers should be overcome.

HS Liyanage, S-T Liaw, CT Di Iorio, C Kuziemsky, R Schreiber, AL Terry, S de Lusignan (2016)Building a Privacy, Ethics, and Data Access Framework for Real World Computerised Medical Record System Data: A Delphi Study, In: IMIA Yearbook of Medical Informatics2016pp. 138-145 Schattauer GmbH

Background: Privacy, ethics, and data access issues pose 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.

Norman Poh, S Bull, Santosh Tirunagari, Simon de Lusignan (2017)A Probabilistic Broken-stick Model for CKD Staging and Risk Stratification

Introduction: Determining CKD stage and disease progression based on eGFR in primary care is complicated by the fact that the measurements are irregularly sampled and influenced by both genuine physiological changes and external factors. Models used for these purposes would ideally capture both short- (for staging) and long-term (for progression) trends. However, existing regression algorithms such as linear, polynomial and Gaussian process regression either cannot account for these challenges or do not satisfy the key clinical requirements of providing an easily interpretable model that can elucidate short- and long-term trends. In order to balance interpretability and flexibility, an extension to broken-stick regression models is proposed in order to make them more suitable for modelling clinical time series.

N Poh, S de Lusignan, H Liyanage, J van Vlymen, P Krause, S Jones (2013)Agile Exploration of Electronic Health Records with Application to Comparing the Quality of Blood Pressure Control in Pay-for-Performance Targets in a Cross-Sectional Study., In: Stud Health Technol Inform192pp. 82-86

Computerised Medical Record (CMR) data are widely used for secondary purposes such as service evaluation and epidemiological research. Data are increasingly aggregated from different medical facilities with various CMR vendors over time. It is increasingly difficult to manage the large quantity of data. Experiential learning in diabetes and chronic kidney disease (CKD) suggests simplistic processing can lead to errors. To maximise analytical ability for the Quality Improvement in CKD (QICKD) trial, we developed an agile data management process. By removing the need to import and process data in a relational data-base, we reduced processing and analysis time. We demonstrated usage of our new agile method to rapidly develop complex queries to identify how blood pressure varied between patients included or excluded from Quality and Outcomes Frameworks (QOF) pay-for-performance (P4P) targets in UK primary care. We describe a novel specification language that allows clinicians to focus on identifying variables to extract useful information from CMRs. Data for research questions were available in <1hour instead of longer times previously required through use of an SQL database.

CB Phillips, CM Pearce, S Hall, J Travaglia, S de Lusignan, T Love, M Kljakovic (2010)Can clinical governance deliver quality improvement in Australian general practice and primary care? A systematic review of the evidence, In: MEDICAL JOURNAL OF AUSTRALIA193(10)pp. 602-607 AUSTRALASIAN MED PUBL CO LTD
Freda Elizabeth Mold, Jane Hendy, Yi-Ling Lai, Simon de Lusignan (2019)E-consultation in primary care: A systematic review, In: E-consultation in primary care: A systematic review (Preprint) JMIR Publictions

Background: Governments and healthcare providers are keen to find innovative ways to more efficiently deliver care. Interest in e-consultation has grown, but evidence of benefit is uncertain. Objective: Aims: To assess the evidence of delivering e-consultation using secure email/messaging or video links in primary care. Methods: A systematic review was conducted on the use and application of e-consultations in primary care. We searched seven international databases (Medline, Embase, CINAHL, Cochrane Library, PsycINFO, Econlit and Web of Science) (1999-2017), identifying 52 relevant studies. Papers were screened against a detailed inclusion and exclusion criteria. Independent dual data extraction was conducted and assessed for quality. The resulting evidence was synthesised using thematic analysis. Results: This review included fifty-seven (n=57) studies from a range of countries, mainly the USA (n=30) and the UK (n=13). There were disparities in uptake and utilisation towards more use by younger, employed adults. Patient responses to e-consultation were mixed. Patients reported satisfaction with services and improved self-care, communication and engagement with clinicians. Evidence for the acceptability and ease of use was strong, especially for those with long-term conditions and patients located in remote regions. However, patients were concerned about the privacy and security of their data. For primary healthcare staff, e-consultation delivers challenges around time-management, having the correct technological infrastructure, whether it offers a comparable standard of clinical quality, and whether it improves health outcomes. Conclusions: E-consultations may improve aspects of care delivery, but the small scale of many of the studies and low adoption rates leaves unanswered questions about usage, quality, cost and sustainability. We need to improve e-consultation implementation, demonstrate how e-consultations will not increase disparities in access, provide better reassurance to patients about privacy, and incorporate e-consultation as part of a manageable clinical workflow. Clinical Trial: PROSPERO (International Prospective Register of Systematic Reviews) Registration Number: CRD42015019152

Norman Poh, S Bull, Santosh Tirunagari, John Williams, N Cole, C Farmer, Simon de Lusignan (2017)Identifying Progressive CKD from Primary Care Records – a Study Protocol
H Liyanage, S de Lusignan, ST Liaw, CE Kuziemsky, F Mold, P Krause, D Fleming, S Jones (2014)Big Data Usage Patterns in the Health Care Domain: A Use Case Driven Approach Applied to the Assessment of Vaccination Benefits and Risks. Contribution of the IMIA Primary Healthcare Working Group., In: Yearb Med Inform9pp. 27-35 Schattauer

BACKGROUND: Generally benefits and risks of vaccines can be determined from studies carried out as part of regulatory compliance, followed by surveillance of routine data; however there are some rarer and more long term events that require new methods. Big data generated by increasingly affordable personalised computing, and from pervasive computing devices is rapidly growing and low cost, high volume, cloud computing makes the processing of these data inexpensive. OBJECTIVE: To describe how big data and related analytical methods might be applied to assess the benefits and risks of vaccines. METHOD: We reviewed the literature on the use of big data to improve health, applied to generic vaccine use cases, that illustrate benefits and risks of vaccination. We defined a use case as the interaction between a user and an information system to achieve a goal. We used flu vaccination and pre-school childhood immunisation as exemplars. RESULTS: We reviewed three big data use cases relevant to assessing vaccine benefits and risks: (i) Big data processing using crowdsourcing, distributed big data processing, and predictive analytics, (ii) Data integration from heterogeneous big data sources, e.g. the increasing range of devices in the "internet of things", and (iii) Real-time monitoring for the direct monitoring of epidemics as well as vaccine effects via social media and other data sources. CONCLUSIONS: Big data raises new ethical dilemmas, though its analysis methods can bring complementary real-time capabilities for monitoring epidemics and assessing vaccine benefit-risk balance.

AS Ansari, Simon de Lusignan, B Arrowsmith, W Hinton, N Munro, A McGovern (2016)Association Between Diabetes, Level of Glycaemic Control, and Eye Infection: A Cohort Study, In: Diabetes Care40(3)pp. e30-e31 American Diabetes Association
Shankar Kumar, Simon de Lusignan, Andrew Mcgovern, Ana Correa, M Hriskova, P Gatenby, S Jones, D Goldsmith, J Camm (2018)Ischaemic stroke, haemorrhage and mortality in elderly patients with chronic kidney disease newly started on anticoagulation for atrial fibrillation: a population-based study from UK primary care, In: BMJ360k342pp. 1-10 BMJ Publishing Group

Objective 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. Design Propensity matched, population based, retrospective cohort analysis from January 2006 through December 2016. Setting 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. Participants Patients aged 65 years and over with a new diagnosis of atrial fibrillation and estimated glomerular filtration rate (eGFR) of

JL Hine, Simon de Lusignan, D Burleigh, S Pathirannehelage, A McGovern, P Gatenby, S Jones, D Jiang, J Williams, AJ Elliot, GE Smith, J Brownrigg, R Hinchliffe, N Munro (2016)Association between glycaemic control and common infections in people with Type 2 diabetes: a cohort study, In: Diabetic Medicine34(4)pp. 551-557 Wiley

Aim To investigate the impact of glycaemic control on infection incidence in people with Type 2 diabetes. Methods 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 < 53 mmol/mol (< 7%)], moderate [HbA1c 53–69 mmol/mol (7–8.5%)] and poor [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. Results 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. Conclusions 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.

Vari M Drennan, Simon de Lusignan, Heather Gage, Jon Gabe, Mary Halter (2018)Building an evidence base for the primary care workforce, In: BMJ360 BMJ Publishing Group

Building an evidence base for the effects of different types of staff in general practice is challenging and takes time. McCartney is right to say that no evidence shows that physician associates make a difference to clinician stress and burnout. But more evidence is available than she suggests, which may be important at a time of considerable vacancies for general practitioners and practice nurses.

AP McGovern, S de Lusignan, J van Vlymen, H Liyanage, CR Tomson, H Gallagher, M Rafiq, S Jones (2013)Serum Phosphate as a Risk Factor for Cardiovascular Events in People with and without Chronic Kidney Disease: A Large Community Based Cohort Study., In: PLoS One8(9)pp. e74996-?

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.

MF Halter, VM Drennan, LM Joly, J Gabe, Heather Gage, Simon de Lusignan (2017)The patients’ perspective of physician associates in primary care in England: a qualitative study, In: Health Expectations20(5)pp. 1011-1019 Wiley

Background: Physician Associates are new to English general practice and set to expand in numbers. Objective: To investigate the patients’ perspective on consulting with PAs in general practice. Design: A qualitative study, using semi structured interviews, with thematic analysis. Setting and participants: Thirty volunteer patients of 430 who had consulted PAs for a same day appointment and had returned a satisfaction survey, in six general practices employing physician associates in England. Findings: 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 was 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. Conclusion: Patients saw PAs as an appropriate general practitioner substitute. Patients’ experience could inform delivery redesign.

Michael Rigby, Shalmali Deshpande, Daniela Luzi, Fabrizio Pecoraro, Oscar Tamburis, Ilaria Rocco, Barbara Corso, Nadia Mimnicuci, Harshana Liyanage, Uy Hoang, Filipa Ferreira, Simon de Lusignan, Ekelechi MacPepple, Heather Gage (2019)The Invisibility of Children in Data systems, In: Issues and Opportunities in Primary Health Care for Children in Europe: The Final Summarised Results of the Models of Child Health Appraised (MOCHA) Projectpp. 129-158 Emerald Publishing Limited
S de Lusignan, C Mimnagh (2006)Breaking the first law of informatics: the Quality and Outcomes Framework (QOF) in the dock., In: Inform Prim Care14(3)pp. 153-156
Simon de Lusignan, S Jones, S-T Liaw, Georgios Michalakidis (2012)Defining datasets and creating data dictionaries for quality improvement and research in chronic disease using routinely collected data: An ontology-driven approach, In: Informatics in Primary Care19(3)pp. 127-134

Background: The burden of chronic disease is increasing, and research and quality improvement will be less effective if case finding strategies are suboptimal. Objective: To describe an ontology-driven approach to case finding in chronic disease and how this approach can be used to create a data dictionary and make the codes used in case finding transparent. Method: A five-step process: (1) identifying a reference coding system or terminology; (2) using an ontology-driven approach to identify cases; (3) developing metadata that can be used to identify the extracted data; (4) mapping the extracted data to the reference terminology; and (5) creating the data dictionary. Results: Hypertension is presented as an exemplar. A patient with hypertension can be represented by a range of codes including diagnostic, history and administrative. Metadata can link the coding system and data extraction queries to the correct data mapping and translation tool, which then maps it to the equivalent code in the reference terminology. The code extracted, the term, its domain and subdomain, and the name of the data extraction query can then be automatically grouped and published online as a readily searchable data dictionary. An exemplar online is: www.clininf.eu/qickd-datadictionary. html Conclusion: Adopting an ontology-driven approach to case finding could improve the quality of disease registers and of research based on routine data. It would offer considerable advantages over using limited datasets to define cases. This approach should be considered by those involved in research and quality improvement projects which utilise routine data.

Santosh Tirunagari, S Bull, F Christopher, Simon de Lusignan, Norman Poh (2017)Automatically Detecting AKI Events from Primary Care Records

Introduction: Acute kidney injury (AKI) is characterised by a rapid deterioration in kidney function, and can be identified by examining the rate of change in a patient’s estimated glomerular filtration rate (eGFR). Due to the potentially irreversible nature of the damage AKI episodes cause to renal function, their detection can play a significant role in predicting a kidney’s effectiveness. Although algorithms for the detection of AKI are available for patients under constant monitoring, e.g. inpatients, their applicability to primary care settings is less clear as patients’ eGFR often contains large lapses in time between measurements. We therefore present two alternative automated approaches for detecting AKI: using the novel Surrey AKI detection algorithm (SAKIDA) (Figure a) and as the outlier points when using Gaussian process regression (GPR) (Figure b).

AA Kousoulis, I Rafi, S De Lusignan (2015)The CPRD and the RCGP: Building on research success by enhancing benefits for patients and practices, In: British Journal of General Practice65(631)pp. 54-55 Royal College of General Practitioners

Anonymised primary care electronic 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.

Norman Poh, S Bull, Santosh Tirunagari, C Farmer, N Cole, Simon de Lusignan (2017)A Factored Co-morbidity Approach for Modelling CKD Progression

Introduction: One of the key challenges in understanding CKD progression is its multifaceted aetiology. This is evident as it is commonly observed that hypertension, heart disease and diabetes are common co-morbidities of CKD. In other words, the existence of co-morbidities can potentially alter the risk of CKD progression, e.g. from stage 3 to 5. Unfortunately, “flat” risk models such as logistic regression, e.g. as implemented by the QKidney score and many similar risk models, are not designed to extract the rich structure induced by a multitude of co-morbidities, the state of which are often captured in routinely collected patient data.

A Leong, P Koczan, S De Lusignan, I Sheeler (2006)A framework for comparing video methods used to assess the clinical consultation: a qualitative study, In: MEDICAL INFORMATICS AND THE INTERNET IN MEDICINE31(4)pp. 255-265 TAYLOR & FRANCIS LTD
A Vaziri, E Connor, I Shepherd, RT Jones, T Chan, S de Lusignan (2009)Are we setting about improving the safety of computerised prescribing in the right way? A workshop report., In: Inform Prim Care17(3)pp. 175-182

Prescribing errors are common and costly. Technology should enable safer prescribing. The two main current methods of doing so are computer initiated clinical support software (CDSS) and the user initiated information retrieval (IR) systems. However, despite the near universal availability of computerised prescribing support in the UK, errors continue.

S de Lusignan, C Pearce, NT Shaw, ST Liaw, G Michalakidis, MT Vicente, M Bainbridge, International (IMIA), European (EFMI) Medical Informatics Association, Federation Primary Care Informatics Working Groups (PCI-WG) (2011)What are the barriers to conducting international research using routinely collected primary care data?, In: Stud Health Technol Inform165pp. 135-140

BACKGROUND: Primary care is computerized with routine data recorded at the point or care. Secondary use of these data includes: genetic study, epidemiology and clinical trials. However, there are relatively few international studies. OBJECTIVE: To identify the concepts that might predict readiness to collaborate in international research using routinely collected primary care data METHOD: Literature review and data gathering exercise, from international Primary Care Informatics working group workshops, and email modified Delphi exercise. RESULTS: To establish whether primary care data are fit for use in a collaborative study information is needed at the micro-, meso-, and macro-level. At the micro- or data level we need to use documented standards for interoperability, computerized records, to facilitate linkage of data. At the meso-level we need to understand the nature of the electronic patient record (EPR) and specific study requirements. At the macro-level: health system, social and cultural context constrain what data are available. The framework defines the information needed at the point of expression of interest, and joining a study. The initial assessment of readiness should be by self-assessment followed by an in depth appraisal more immediately prior to the start of the study. Finally, a sensitivity analysis should be conducted to test the robustness of the data model. CONCLUSIONS: The literature focuses on technical issues: interoperability, EPR and modeling; the workshops on socio-cultural and organizational. This framework will form the basis for developing a survey instrument of the initial assessment of readiness for collaboration in international research.

M Rafiq, A McGovern, S Jones, K Harris, C Tomson, H Gallagher, S de Lusignan (2014)Falls in the elderly were predicted opportunistically using a decision tree and systematically using a database-driven screening tool., In: J Clin Epidemiol

To identify risk factors for falls and generate two screening tools: an opportunistic tool for use in consultation to flag at risk patients and a systematic database screening tool for comprehensive falls assessment of the practice population.

Ilaria Rocco, Barbara Corso, Daiela Luzi, Fabrizio Pecoraro, Oscar Tamburis, Uy Hoang, Harshana Liyanage, Filipa Ferreira, Simon de Lusignan, Nadia Minicuci (2019)The Conundrum of Measuring Children's Primary Health Care, In: Issues and Opportunities in Primary Health Care for Children in Europe: The Final Summarised Results of the Models of Child Health Appraised (MOCHA) Projectpp. 159-178 Emerald Publishing Limited
S de Lusignan, T Chan, O Wood, N Hague, T Valentin, J Van Vlymen (2005)Quality and variability of osteoporosis data in general practice computer records: implications for disease registers, In: PUBLIC HEALTH119(9)pp. 771-780 W B SAUNDERS CO LTD
Z Tippu, A Correa, H Liyanage, D Burleigh, A McGovern, J Van Vlymen, S Jones, Simon de Lusignan (2017)Ethnicity Recording in Primary Care Computerised Medical Record Systems: An Ontological Approach, In: Journal of Innovation in Health Informatics23(4)pp. 799-806 BCS, The Chartered Institute for IT

Background Ethnicity recording within primary care computerised medical record (CMR) systems is suboptimal, exacerbated by tangled taxonomies within current coding systems. Objective To develop a method for extending ethnicity identification using routinely collected data. Methods 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). Results 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%). Conclusions This mapping method substantially increases the prevalence of known ethnicity in CMR data and may aid future epidemiological research based on routine data.

S de Lusignan, L Crawford (2015)Creating and using real-world evidence to answer questions about clinical effectiveness, In: J Innov Health Inform.22(3)pp. 368-373 BCS, The Chartered Institute for IT

New forms of evidence are needed to complement evidence generated from randomised controlled trials (RCTs). Real-World Evidence (RWE) is a potential new form of evidence, but remains undefined. 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.

S de Lusignan (2006)Biomedical Informatics: developing university, healthcare and industrial partnerships., In: Inform Prim Care14(4)pp. 255-256
B Klebe, C Farmer, R Cooley, S de Lusignan, R Middleton, D O'Donoghue, J New, P Stevens (2007)Kidney disease management in UK primary care: guidelines, incentives and Information Technology, In: FAMILY PRACTICE24(4)pp. 330-335 OXFORD UNIV PRESS
L. Rayner, J. Sherlock, B. Creagh-Brown, J. Williams, S. de Lusignan (2017)The prevalence of COPD in England: An ontological approach to case detection in primary care, In: Respiratory Medicine132pp. 217-225 Elsevier

Background Chronic obstructive pulmonary disease (COPD) is a significant cause of morbidity and mortality in England, however estimates of its prevalence vary considerably. Routinely collected and coded primary care data can be used to monitor disease prevalence, however reliance upon diagnostic codes alone is likely to miss cases. Methods We devised an ontological approach to COPD case detection and implemented it in a large primary care database to identify definite and probable cases of COPD. We used this to estimate the prevalence of COPD in England. Results Use of this approach to detect definite COPD cases yielded a prevalence of 2.57% (95% CI 2.55–2.60) in the total population, 4.56% (95%CI 4.52–4.61) in those aged ≥ 35 and 5.41% (95% CI 5.36–5.47) in ex or current smokers. The ontological approach identified an additional 10,543 definite cases compared with using diagnostic codes alone. Prevalence estimates were higher than the 1.9% prevalence currently reported by the UK primary care pay for performance (P4P) disease register. COPD prevalence when definite and probable cases were combined was 3.02% (95% CI 3.0–3.05) in the total population, 5.38% (95% CI 5.33–5.42) in those aged ≥ 35 and 6.46% (95% CI 6.46-6.40-6.56) in ex or current smokers. Conclusions We demonstrate a robust reproducible method for COPD case detection in routinely collected primary care data. Our calculated prevalence differed significantly from current estimates based upon P4P data, suggesting that the burden of COPD in England is greater than currently predicted.

C Wheeler, M Halter, VM Drennan, Simon de Lusignan, R Grant, J Gabe, Heather Gage, P Begg, J Ennis, J Parle (2017)Physician associates working in secondary care teams in England: Interprofessional implications from a national survey, In: Journal of Interprofessional Care31(6)pp. 774-776 Taylor & Francis:

Physician associates (PAs) are a new type of healthcare professional to the United Kingdom; however, they are well established in the United States (where they are known as physician assistants). PAs are viewed as one potential solution to the current medical workforce doctor shortage. This study investigated the deployment of PAs within secondary care teams in England, through the use of a cross-sectional electronic, self-report survey. The findings from 14 questions are presented. Sixty-three PAs working in a range of specialties responded. A variety of work settings were reported, most frequently inpatient wards, with work generally taking place during weekdays. Both direct and non-direct patient care activities were reported, with the type of work undertaken varying at times, depending on the presence or absence of other healthcare professionals. PAs reported working within a variety of secondary care team staffing permutations, with the majority of these being interprofessional. Line management was largely provided by consultants; however day-to-day supervision varied, often relating to different work settings. A wide variation in ongoing supervision was also reported. Further research is required to understand the nature of PAs’ contribution to collaborative care within secondary care teams in England.

A Bagheri, A Sadek, T Chan, K Khunti, S de Lusignan (2009)Using surrogate markers in primary electronic patient record systems to confirm or refute the diagnosis of diabetes., In: Inform Prim Care17(2)pp. 121-129

UK primary care records are computerised and these records are used for both research and quality improvement. However, there is disparity in the prevalence of diabetes found in epidemiological studies compared with that reported through the UK's national quality improvement scheme.

Andrew Mcgovern, M Feher, N Munro, Simon de Lusignan (2017)Sodium-Glucose Co-transporter 2 (SGLT2) Inhibitor: Comparing Trial Data and Real-World Use, In: Diabetes Therapy8(2)pp. 365-376 Springer

Introduction: The first cardiovascular safety trial in the sodium-glucose co-transporter-2 (SGLT2) inhibitor drug class, the Empagliflozin Cardiovascular Outcomes and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial, demonstrated significant cardiovascular risk reduction with empagliflozin. It is currently not clear what proportions of people with type 2 diabetes (T2DM) have the same high cardiovascular risk as those included in the trial, and will therefore be likely to experience the same cardiovascular benefit. We aimed to identify and describe the proportion of people with T2DM from a representative English national population who have the comparable high cardiovascular risk to those included in the EMPA-REG trial. Method: A cross-sectional analysis of cardiovascular risk in people with T2DM and a subgroup prescribed SGLT2 inhibitors. Patients were identified from the Royal College of General Practitioners Research and Surveillance Centre database. Cardiovascular risk factors were identified from electronic patient records. Results: From 1,238,909 patients at 128 GP practices, we identified 60,327 adults with T2DM (mean age 66.1 years, SD 13.9) of whom 55.6% were male. From these 1642 (2.7%) people had been initiated on an SGLT2 inhibitor (mean age 58.1 years, SD 10.4; 58.8% male). In the complete T2DM group only 15.7% (95% CI 15.5–16.0%) had the same high cardiovascular risk as those included in the EMPA-REG trial. In those already initiated on SGLT2 inhibitors this proportion was 11.1% (95% CI 9.8–12.4%). Whilst the proportion was higher in the oldest age groups, in those 70? years old less than a quarter met the EMPA-REG trial high cardiovascular risk criteria. Conclusions: The EMPA-REG trial results are applicable only to a small proportion of people with T2DM and a smaller proportion of those currently treated with SGLT2 inhibitors. Additional data are required to identify any cardiovascular benefit in people with lower cardiovascular risk.

Most chronic diseases are managed in primary and ambulatory care. The chronic care model (CCM) suggests a wide range of community, technological, team and patient factors contribute to effective chronic disease management. Ontologies have the capability to enable formalised linkage of heterogeneous data sources as might be found across the elements of the CCM.

Simon de Lusignan (2017)In this issue: Innovation in design and implementation in health informatics, In: Journal of Innovation in Health Informatics24(2) BCS, The Chartered Institute for IT
ST Liaw, C Pearce, H Liyanage, GS Liaw, S de Lusignan (2014)An integrated organisation-wide data quality management and information governance framework: theoretical underpinnings., In: Inform Prim Care21(4)pp. 199-206

INTRODUCTION: Increasing investment in eHealth aims to improve cost effectiveness and safety of care. Data extraction and aggregation can create new data products to improve professional practice and provide feedback to improve the quality of source data. A previous systematic review concluded that locally relevant clinical indicators and use of clinical record systems could support clinical governance. We aimed to extend and update the review with a theoretical framework. METHODS: We searched PubMed, Medline, Web of Science, ABI Inform (Proquest) and Business Source Premier (EBSCO) using the terms curation, information ecosystem, data quality management (DQM), data governance, information governance (IG) and data stewardship. We focused on and analysed the scope of DQM and IG processes, theoretical frameworks, and determinants of the processing, quality assurance, presentation and sharing of data across the enterprise. FINDINGS: There are good theoretical reasons for integrated governance, but there is variable alignment of DQM, IG and health system objectives across the health enterprise. Ethical constraints exist that require health information ecosystems to process data in ways that are aligned with improving health and system efficiency and ensuring patient safety. Despite an increasingly 'big-data' environment, DQM and IG in health services are still fragmented across the data production cycle. We extend current work on DQM and IG with a theoretical framework for integrated IG across the data cycle. CONCLUSIONS: The dimensions of this theory-based framework would require testing with qualitative and quantitative studies to examine the applicability and utility, along with an evaluation of its impact on data quality across the health enterprise.

D Gordon, A Bone, R Pebody, Simon de Lusignan (2017)The GP's role in promoting winter wellness, In: British Journal of General Practice67(655) Royal College of General Practitioners

Every year in the UK there is a seasonal peak in morbidity and mortality during the coldest months. GPs have an important role in promoting winter wellness and we would like to advocate GPs placing more emphasis on a proactive approach designed to reduce risk among vulnerable individuals and families. Although some of the activities we already undertake contribute to this goal, others fall short, and few of us promote winter wellness in a coordinated way across our health and social care community. To maximise our effectiveness, primary care teams should be aware of the modifiable risk factors for excess winter mortality and morbidity; and actively manage these as part of planned as well as opportunistic care.

C Woodmansey, Andrew Mcgovern, K McCullough, Martin Whyte, N Munro, Ana Correa, P Gatenby, Simon Jones, Simon de Lusignan (2017)Incidence, Demographics, and Clinical Characteristics of Diabetes of the Exocrine Pancreas (Type 3c): A Retrospective Cohort Study, In: Diabetes Care40(11)pp. 1486-1493 American Diabetes Association

OBJECTIVE: This study was conducted to describe the incidence of diabetes following pancreatic disease, assess how these patients are classified by clinicians, and compare clinical characteristics with type 1 and type 2 diabetes. 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 ≥7% [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 < 0.001). The 559 cases of diabetes following pancreatic disease were mostly classified by clinicians as type 2 diabetes (87.8%) and uncommonly as diabetes of the exocrine pancreas (2.7%). Diabetes following pancreatic disease was diagnosed at a median age of 59 years and BMI of 29.2 kg/m2. Diabetes following pancreatic disease was associated with poor glycemic control (adjusted odds ratio, 1.7 [1.3–2.2]; P < 0.001) compared with type 2 diabetes. Insulin use within 5 years was 4.1% (3.8–4.4) with type 2 diabetes, 20.9% (14.6–28.9) with diabetes following acute pancreatitis, and 45.8% (34.2–57.9) with diabetes following chronic pancreatic disease. CONCLUSIONS: Diabetes of the exocrine pancreas is frequently labeled type 2 diabetes but has worse glycemic control and a markedly greater requirement for insulin.

A McGovern, R Hinchliffe, N Munro, S de Lusignan (2015)Basing approval of drugs for type 2 diabetes on real world outcomes., In: BMJ351pp. h5829-h5829 BMJ Publishing Group
W Hinton, AP McGovern, J van Vlymen, N Munro, M Whyte, S de Lusignan (2016)Real-world evidence on the prescribing trends of glucagon-like peptide-1 agonists in UK primary care, In: DIABETIC MEDICINE33pp. 165-165 WILEY-BLACKWELL
E Guthrie, C Afzal, C Blakeley, A Blakemore, Rachel Byford, E Camacho, T Chan, C Chew-Graham, L Davies, Simon de Lusignan, C Dickens, J Drinkwater, G Dunn, C Hunter, Mark Joy, N Kapur, S Langer, K Lovell, J Macklin, K Mackway-Jones, D Ntais, P Salmon, B Tomenson, J Watson (2017)CHOICE: Choosing Health Options In Chronic Care Emergencies, In: Programme Grants for Applied Research5(13)pp. 1-271

Background: 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. Objectives: 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). Design: 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 ≥ 18 years with at least one of four common LTCs: asthma, coronary heart disease, chronic obstructive pulmonary disease (COPD) and diabetes. Participants also included health-care staff. Results: 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. Limitations: 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 people with LTCs. However, psychosocial factors, particularly depression, are important additional predictors of use of unscheduled care in patients with LTCs, independent of severity and multimorbidity. Patients and health-care practitioners are unaware that psychosocial factors influence health-care use, and such factors are rarely acknowledged or addressed in consultations or discussions about use of unscheduled care. A targeted patient intervention for people with LTCs and comorbid depression has shown high levels of acceptability when delivered in a primary care context. An intervention at the level of the GP practice showed little evidence of acceptability or cost-effectiveness. Future work: The potential benefits of case-finding for depression in patients with LTCs in primary care need to be evaluated, in addition to further evaluation of the targeted patient intervention.

PE Stevens, CKT Farmer, Simon de Lusignan (2011)Effect of pay for performance on hypertension in the United Kingdom, In: American Journal of Kidney Diseases58(4)pp. 508-511
MA Tahir, O Dmitrieva, S de Lusignan, J van Vlymen, T Chan, R Golmohamad, K Harris, C Tomson, N Thomas, H Gallagher (2011)Confidence and quality in managing CKD compared with other cardiovascular diseases and diabetes mellitus: a linked study of questionnaire and routine primary care data., In: BMC Fam Pract12pp. 83-?

ABSTRACT:

Health care, in common with many other industries, is generating large amounts of routine data, data that are challenging to process, analyse or curate, so-called 'big data'. A challenge for health informatics is to make sense of these data. Part of the answer will come from the development of ontologies that support the use of heterogeneous data sources and the development of intermediate processors of health information (IPHI). IPHI will sit between the generators of health data and information, often the providers of health care, and the managers, commissioners, policy makers, researchers, and the pharmaceutical and other healthcare industries. They will create a health ecosystem by processing data in a way that stimulates improved data quality and potentially healthcare delivery by providers of health care, and by providing greater insights to legitimate users of data. Exemplars are provided of how a health ecosystem might be encouraged and developed to promote patient safety and more efficient health care. These are in the areas of how to integrate data around the unsafe use of alcohol and to explore vaccine safety. A challenge for IPHI is how to ensure that their processing of data is valid, safe and maintains privacy. Development of the healthcare ecosystem and IPHI should be actively encouraged internationally. Governments, regulators and providers of health care should facilitate access to health data and the use of national and international comparisons to monitor standards. However, most importantly, they should pilot new methods of improving quality and safety through the intermediate processing of health data.

AS Ansari, Simon de Lusignan, William Hinton, N Munro, Andrew Mcgovern (2017)The association between diabetes, level of glycaemic control and eye infection: Cohort database study, In: Primary Care Diabetes11(5)pp. 421-429 Elsevier

Aim: To examine whether diabetes and the degree of glycaemic control is associated with 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 ≥15 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 < 0.0001 and OR 1.11; 95% CI 1.06–1.16; p < 0.0001 respectively). No association was found 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 < 0.0001 and type 2 OR 1.17; 95% CI 1.13–1.20; p < 0.0001). 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

Simon de Lusignan (2017)In this issue: everything you wanted to know about electronic health exchange, diversity and ethnicity, In: Journal of Innovation in Health Informatics23(4) BCS, The Chartered Institute for IT

A rating scale was developed to assess the contribution made by computer software towards the delivery of a quality consultation, with the purpose of informing the development of the next generation of systems. Two software programmes were compared, using this scale to test their ability to enable or inhibit the delivery of an ideal consultation with a patient with heart disease. The context was a general practice based, nurse run clinic for the secondary prevention of heart disease. One of the programmes was customized for this purpose; the other was a standard general practice programme. Consultations were video-recorded, and then assessed by an expert panel using the new assessment tool. Both software programmes were oriented towards the implementation of the evidence, rather than facilitating patient-centred practice. The rating scale showed, not surprisingly, significantly greater support from the customized software in the consultation in five out of eight areas. However, the scale's reliability measured by Cronbach's Alpha, was sub-optimal. With further refinement, this rating scale may become a useful tool that will inform software developers of the effectiveness of their programmes in the consultation, and suggest where they need development. © 2002 Informa UK Ltd All rights reserved.

R Haux, CA Kulikowski, S Bakken, Simon de Lusignan, M Kimura, S Koch, J Mantas, V Maojo, M Marschollek, F Martin-Sanchez, A Moen, HA Park, IN Sarkar, TY Leong, AT McCray (2017)Research Strategies for Biomedical and Health Informatics. Some Thought-provoking and Critical Proposals to Encourage Scientific Debate on the Nature of Good Research in Medical Informatics, In: Methods of Information in Medicine56pp. e1-e10 Wiley Open Access

Background: 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. Objectives: 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? Methods: 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. Results: 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. Conclusions: 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.

Abstract. Immunisation is an important part of health care and adverse events following immunisation (AEFI) are relatively rare. AEFI can be detected through long term follow up of a cohort or from looking for signals from real world, routine data; from different health systems using a variety of clinical coding systems. Mapping these is a challenging aspect of integrating data across borders. Ontological representations of clinical concepts provide a method to map similar concepts, in this case AEFI across different coding systems. We describe a method using ontologies to be flag definite, probable or possible cases. We use Guillain- Barre syndrome (GBS) as an AEFI to illustrate this method, and the Brighton collaboration’s case definition of GBS as the gold standard. Our method can be used to flag definite, probable or possible cases of GBS. Whilst there has been much research into the use of ontologies in immunisation these have focussed on database interrogation; where ours looks to identify varying signal strength.

VM Drennan, J Gabe, M Halter, Simon de Lusignan, R Levenson (2017)Physician associates in primary health care in England: A challenge to professional boundaries?, In: Social Science and Medicine181pp. 9-16 Elsevier

Like other health care systems, the National Health Service (NHS) in England has looked to new staffing configurations faced with medical staff shortages and rising costs. One solution has been to employ physician associates (PAs). PAs are trained in the medical model to assess, diagnose and commence treatment under the supervision of a physician. This paper explores the perceived effects on professional boundaries and relationships of introducing this completely new professional group. It draws on data from a study, completed in 2014, which examined the contribution of PAs working in general practice. Data were gathered at macro, meso and micro levels of the health care system. At the macro and meso level data were from policy documents, interviews with civil servants, senior members of national medical and nursing organisations, as well as regional level NHS managers (n = 25). At the micro level data came from interviews with General Practitioners, nurse practitioners and practice staff (n = 30) as well as observation of clinical and professional meetings. Analysis was both inductive and also framed by the existing theories of a dynamic system of professions. It is argued that professional boundaries become malleable and subject to negotiation at the micro level of service delivery. Stratification within professional groups created differing responses between those working at macro, meso and micro levels of the system; from acceptance to hostility in the face of a new and potentially competing, occupational group. Overarching this state agency was the requirement to underpin legislatively the shifts in jurisdictional boundaries, such as prescribing required for vertical substitution for some of the work of doctors.

Vari M Drennan, Mary Halter, Carly Wheeler, Laura Nice, Sally Brearley, James Ennis, Jon Gabe, Heather Gage, Ros Levenson, Simon de Lusignan, Phil Begg, Jim Parle (2019)The role of physician associates in secondary care: the PA-SCER mixed-methods study, In: Health Services and Delivery Research7(19)pp. 1-158 NIHR Journals Library

Background:Increasing demand for hospital services and staff shortages has led NHS organisations to review workforce configurations. One solution has been to employ physician associates (PAs). PAs are trained over 2 years at postgraduate level to work to a supervising doctor. Little is currently known about the roles and impact of PAs working in hospitals in England. Objectives:(1) To investigate the factors influencing the adoption and deployment of PAs within medical and surgical teams in secondary care and (2) to explore the contribution of PAs, including their impact on patient experiences, organisation of services, working practices, professional relationships and service costs, in acute hospital care. Methods:This was a mixed-methods, multiphase study. It comprised a systematic review, a policy review, national surveys of medical directors and PAs, case studies within six hospitals utilising PAs in England and a pragmatic retrospective record review of patients in emergency departments (EDs) attended by PAs and Foundation Year 2 (FY2) doctors. Results:The surveys found that a small but growing number of hospitals employed PAs. From the case study element, it was found that medical and surgical teams mainly used PAs to provide continuity to the inpatient wards. Their continuous presence contributed to smoothing patient flow, accessibility for patients and nurses in communicating with doctors and releasing doctors’ (of all grades) time for more complex patients and for attending to patients in clinic and theatre settings. PAs undertook significant amounts of ward-based clinical administration related to patients’ care. The lack of authority to prescribe or order ionising radiation restricted the extent to which PAs assisted with the doctors’ workloads, although the extent of limitation varied between teams. A few consultants in high-dependency specialties considered that junior doctors fitted their team better. PAs were reported to be safe, as was also identified from the review of ED patient records. A comparison of a random sample of patient records in the ED found no difference in the rate of unplanned return for the same problem between those seen by PAs and those seen by FY2 doctors (odds ratio 1.33, 95% confidence interval 0.69 to 2.57; p = 0.40). In the ED, PAs were also valued for the continuity they brought and, as elsewhere, their input in inducting doctors in training into local clinical and hospital processes. Patients were positive about the care PAs provided, although they were not able to identify what or who a PA was; they simply saw them as part of the medical or surgical team looking after them. Although the inclusion of PAs was thought to reduce the need for more expensive locum junior doctors, the use of PAs was primarily discussed in terms of their contribution to patient safety and patient experience in contrast to utilising temporary staff. Limitations:PAs work within medical and surgical teams, such that their specific impact cannot be distinguished from that of the whole team. Conclusions:PAs can provide a flexible advanced clinical practitioner addition to the secondary care workforce without drawing from existing professions. However, their utility in the hospital setting is unlikely to be fully realised without the appropriate level of regulation and attendant authority to prescribe medicines and order ionising radiation within their scope of practice. Future research:Comparative investigation is required of patient experience, outcomes and service costs in single, secondary care specialties with and without PAs and in comparison with other types of advanced clinical practitioners. Study registration:The systematic review component of this study is registered as PROSPERO CRD42016032895. Funding:The National Institute for Health Research Health Services and Delivery Research programme.

VM Drennan, K Chattopadhyay, M Halter, S Brearley, Simon de Lusignan, J Gabe, Heather Gage (2012)Physician assistants in English primary care teams: A survey., In: J Interprof Care

Ensuring that healthcare teams have a mix of skilled professionals to meet patient needs and deliver safe and cost-effective services is a major imperative in all health services. The health services in the UK, like a number of other countries, have been exploring the contribution that physician assistants (PAs) can make to healthcare teams including primary care. PAs are well established in the USA, where they have a recognized qualification and undertake physical examinations, investigations, diagnosis, treatment and prescribing within their scope of practice as agreed with their supervising doctor. The first UK-trained PAs graduated in 2009 from post-graduate courses, which are modeled closely on those in the USA to a UK agreed set of competencies and curriculum. There is evidence of the substantive employment of PAs in primary care teams in England. The UK has a well-developed primary care system, with most care delivered via general practice teams which generally include a mix of medical, nursing and support staff. The extent of the employment of PAs in primary care in the England and their contribution within the team to patient care is unknown. This paper reports on a survey that investigated these questions.

Spencer A. Thomas, Nadia A. Smith, Valerie Livina, Ivelina Yonova, Rebecca Webb, Simon de Lusignan (2019)Analysis of Primary Care Computerized Medical Records (CMR) Data With Deep Autoencoders (DAE), In: Frontiers in Applied Mathematics and Statistics542 Frontiers

The use of deep learning is becoming increasingly important in the analysis of medical data such as pattern recognition for classification. The use of primary healthcare computational medical records (CMR) data is vital in prediction of infection prevalence across a population, and decision making at a national scale. To date, the application of machine learning algorithms to CMR data remains under-utilized despite the potential impact for use in diagnostics or prevention of epidemics such as outbreaks of influenza. A particular challenge in epidemiology is how to differentiate incident cases from those that are follow-ups for the same condition. Furthermore, the CMR data are typically heterogeneous, noisy, high dimensional and incomplete, making automated analysis difficult. We introduce a methodology for converting heterogeneous data such that it is compatible with a deep autoencoder for reduction of CMR data. This approach provides a tool for real time visualization of these high dimensional data, revealing previously unknown dependencies and clusters. Our unsupervised nonlinear reduction method can be used to identify the features driving the formation of these clusters that can aid decision making in healthcare applications. The results in this work demonstrate that our methods can cluster more than 97.84% of the data (clusters >5 points) each of which is uniquely described by three attributes in the data: Clinical System (CMR system), Read Code (as recorded) and Read Term (standardized coding). Further, we propose the use of Shannon Entropy as a means to analyse the dispersion of clusters and the contribution from the underlying attributes to gain further insight from the data. Our results demonstrate that Shannon Entropy is a useful metric for analysing both the low dimensional clusters of CMR data, and also the features in the original heterogeneous data. Finally, we find that the entropy of the low dimensional clusters are directly representative of the entropy of the input data (Pearson Correlation = 0.99, R2 = 0.98) and therefore the reduced data from the deep autoencoder is reflective of the original CMR data variability.

Agnieszka Lemanska, RC Byford, Ana Correa, C Cruickshank, DP Dearnaley, C Griffin, E Hall, Simon de Lusignan, Sara Faithfull (2017)Linking CHHiP prostate cancer RCT with GP records: A study proposal to investigate the effect of co-morbidities and medications on long-term symptoms and radiotherapy-related toxicity, In: Technical Innovations & Patient Support in Radiation Oncology2pp. 5-12 Elsevier

Background: 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. Purpose: 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. Methods: 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. Conclusions: 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.

Simon de Lusignan, A Correa (2017)Opportunities and challenges of a World Serum Bank., In: Lancet389(10066)pp. 250-251 Elsevier

The recent publication by Jessica Metcalf and others (Aug 13, p 728),1 calls for the establishment of a World Serum Bank; something we feel should be titled a World Serology Bank given its emphasis on monitoring changes in the immune response to infections. A possible rapid and cost-effective way of setting this up would be to use existing primary care sentinel networks such as the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC).2

Objectives: To observe and analyse the range and nature of behaviour change techniques (BCTs) employed by audiologists during hearing-aid fitting consultations to encourage and enable hearing-aid use. Design: Non-participant observation and qualitative thematic analysis using the behaviour change technique taxonomy (version 1) (BCTTv1). Study sample: Ten consultations across five English NHS audiology departments. Results: Audiologists engage in behaviours to ensure the hearing-aid is fitted to prescription and is comfortable to wear. They provide information, equipment, and training in how to use a hearing-aid including changing batteries, cleaning, and maintenance. There is scope for audiologists to use additional BCTs: collaborating with patients to develop a behavioural plan for hearing-aid use that includes goal-setting, action-planning and problem-solving; involving significant others; providing information on the benefits of hearing-aid use or the consequences of non-use and giving advice about using prompts/cues for hearing-aid use. Conclusions: This observational study of audiologist behaviour in hearing-aid fitting consultations has identified opportunities to use additional behaviour change techniques that might encourage hearing-aid use. This information defines potential intervention targets for further research with the aim of improving hearing-aid use amongst adults with acquired hearing loss.

Andrew Mcgovern, M Feher, N Munro, Simon de Lusignan (2017)Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors: Comparing Trial and Real World Use (Study Protocol), In: Diabetes Therapy8(2)pp. 355-363 Springer Healthcare

Background: Sodium-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. Aim: To 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 Setting: Routinely 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.Method: People 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 Outputs: Peer review publication reporting the real world lessons for clinical practice.

Simon de Lusignan, Emmanouela Konstantara, Mark Joy, Julian Sherlock, Uy Hoang, Rachel Coyle, Filipa Ferreira, Simon Jones, Sarah J O’Brien (2018)Incidence of household transmission of acute gastroenteritis (AGE) in a primary care sentinel network (1992–2017): cross-sectional and retrospective cohort study protocol, In: BMJ Open8(8)e022524pp. e022524-1 BMJ Publishing Group:

Introduction Acute 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 study to describe household transmission of medically attended AGE, and explore whether there is an increased incidence in households with young children. Methods and analysis This study used the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) primary care sentinel network, comprising data from 1 750 167 registered patients (August 2017 database). We conducted a novel analysis using a ’household key', to identify patients within the same household (n=811 027, mean 2.16 people). A 25-year repeated cross-sectional study will explore the incidence of medically attended AGE overall and then a 5-year retrospective cohort study will describe household transmission of AGE. The cross-sectional study will include clinical data for a 25-year period—1 January 1992 until the 31 December 2017. We will describe the incidence of AGE by age-band and gender, and trends in incidence. The 5-year study will use Poisson and quasi-Poisson regression to identify characteristics of individuals and households to predict medically attended AGE transmitted in the household. This will include whether the household contained a child under 5 years and the age category of the first index case (whether adult or child under 5 years). If there is overdispersion and zero-inflation we will compare results with negative binomial to handle these issues. Ethics and dissemination All RCGP RSC data are pseudonymised at the point of data extraction. No personally identifiable data are required for this investigation. The protocol follows STrengthening the Reporting of OBservational studies in Epidemiology guidelines (STROBE). The study results will be published in a peer-review journal, the dataset will be available to other researchers.

S de Lusignan, B Sun, C Pearce, C Farmer, P Steven, S Jones (2014)Coding errors in an analysis of the impact of pay-for-performance on the care for long-term cardiovascular disease: a case study., In: Inform Prim Care21(2)pp. 92-101

There is no standard method of publishing the code ranges in research using routine data. We report how code selection affects the reported prevalence and precision of results.

William Hinton, Harshana Liyanage, Andrew Mcgovern, ST Liaw, C Kuziemsky, N Munro, Simon de Lusignan (2017)Measuring Quality of Healthcare Outcomes in Type 2 Diabetes from Routine Data: a Seven-nation Survey Conducted by the IMIA Primary Health Care Working Group. Primary Health Care Informatics Working Group Contribution to the Year Book of Medical Informatics 2017, In: IMIA Yearbook of Medical Informatics 201726(1)pp. 201-208 Schattauer

Background: 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. Objective: 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. Method: 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. Results: 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. Conclusion: 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.

T Chan, S De Lusignan, A Cohen, N Dhoul, N Hague, J Van Vlymen, AP Roberts (2006)Prescription of psychotropic medications in primary care: A cross-sectional study of general practice computer records, In: Primary Care Mental Health4(2)pp. 81-92

Background: Mental health problems are common in England, and new medications potentially offer equal or greater efficacy with increased patient safety and fewer side-effects. Objective: To examine the use of psychotropic medications in primary care, in particular the use of more modern drug therapies. Subjects and setting: Using routinely collected computer data from 12 general practices with a combined list size of 117 000. Method: We collected anonymised data from general practice computer systems using MIQUEST (Morbidity Information Query and Export Syntax - a Department of Health-sponsored data extraction tool). Data were aggregated, cleaned and processed using an established methodology, then imported into a statistical package for analysis. Results: The use of psychotropic medication increased with age. Over one-third (35%) of women and one-quarter (23.8%) of men of the study population aged over 85 years were prescribed at least one psychotropic medication in the last year (P < 0.001). At all ages, women are twice as likely to be prescribed psychotropic medication, though no more likely to be prescribed multiple therapies. One-quarter of those with a diagnosis of severe and enduring mental illness (SMI) were not taking any psychotropic medication. Over half of those with SMI on medication are taking more than one medication. The proportion of people prescribed atypical anti-psychotics has risen from 30% to 50%, with a corresponding fall in the use of older anti-psychotics. Twenty-one percent of females have been prescribed antidepressants, 14% in the last year. In contrast to anti-psychotics, the proportion of people prescribed more modern antidepressants has increased slightly. Conclusions: Females and older people are much more likely to receive psychotropic medications. Further research is needed to explore why the pattern of prescribing differs from what is known about the pattern of mental health problems. © 2006 Radcliffe Publishing.

Simon de Lusignan, G Dos Santos, Ana Correa, F Haguinet, Ivelina Yonova, F Lair, Rachel Byford, Filipa Ferreira, K Stuttard, T Chan T (2017)Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England, In: BMJ Open78(5)pp. 1-11 BMJ Publishing Group

Aim 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. Study design 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). Setting Ten volunteer English general practices, primarily using the GSK influenza vaccines. They had selected this vaccine in advance of the study. Participants 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. Outcome measures 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.