© 2016 The Author(s)Background: The aims of this study are the following: to describe the female population of reproductive age having bariatric surgery in the UK, to assess the age and ethnicity of women accessing surgery, and to assess the effect of bariatric surgery on factors that underlie fertility and pregnancy outcomes. Methods: Demographic details, comorbidities, and operative type of women aged 18?45 years were extracted from the National Bariatric Surgery Registry (NBSR). A comparison was made with non-operative cases (aged 18?45 and BMI e40 kg/m2) from the Health Survey for England (HSE, 2007?2013). Analyses were performed using ?R? software. Results: Data were extracted on 15,222 women from NBSR and 1073 from HSE. Women aged 18?45 comprised 53 % of operations. Non-Caucasians were under-represented in NBSR compared to HSE (10 vs 16 % respectively, p
Lusignan S, Sismanidis C, Carey IM, DeWilde S, Richards N, Cook DG (2005) Trends in the prevalence and management of diagnosed type 2 diabetes 1994-2001 in England and Wales., BMC Fam Pract 6 (1)
BACKGROUND: Type 2 diabetes is an important cause of morbidity and mortality. Its prevalence appears to be increasing. Guidelines exist regarding its management. Recommendations regarding drug therapy have changed. Little is known about the influence of these guidelines and changed recommendations on the actual management of patients with type 2 diabetes. This study aims to document trends in the prevalence, drug treatment and recording of measures related to the management of type 2 diabetes; and to assess whether recommended targets can be met. METHODS: The population comprised subjects registered between 1994 and 2001 with 74 general practices in England and Wales which routinely contribute to the Doctors' Independent Network database. Approximately 500,000 patients and 10,000 type 2 diabetics were registered in each year. RESULTS: Type 2 diabetes prevalence rose from 17/1000 in 1994 to 25/1000 in 2001. Drug therapy has changed: use of long acting sulphonylureas is falling while that of short acting sulphonylureas, metformin and newer therapies including glitazones is increasing. Electronic recording of HbA1c, blood pressure, cholesterol and weight have risen steadily, and improvements in control of blood pressure and cholesterol levels have occurred. However, glycaemic control has not improved, and obesity has increased. The percentage with a BMI under 25 kg/m2 fell from 27.0% in 1994 to 19.4% in 2001 (p
de Lusignan S (2007) Relearning the lessons about the implementation of information systems in primary care: a report from the European Federation for Medical Informatics (EFMI) Special Topic Conference 2007 in Croatia., Inform Prim Care 15 (3) pp. 167-168
Gibbings-Isaac D, Iqbal M, Tahir MA, Kumarapeli P, de Lusignan S (2012) The pattern of silent time in the clinical consultation: an observational multichannel video study., Fam Pract
OBJECTIVE: To describe silent time in the clinical consultation: who initiates and terminates it and at what stage most silence occurs. METHODS: We conducted an analysis of 127 multichannel video recordings of consultations by 12 GPs; filmed using the ALFA (Aggregation of Log Files for Analysis) open-source toolkit. The start and end of silence was manually coded using an observational data capture tool. We report who initiates and terminates silence, describe the proportion of the consultation, what happens within it and the distribution of silent periods by quartile of the consultation. RESULTS: We found the median proportion of silence was 12.3% and interquartile range 14.3%. Silent periods (52.4%) were both initiated and terminated by the doctor. The majority of silent time (78.1%) is spent on computer-based activities and physical examination. Silent periods which do not involve physical examination mainly occur in the second half of the consultation and represent 70.6% of the total duration and 64.8% of the episodes of silence. CONCLUSIONS: The computer is a third party in the GP consultation and often requires silent time during doctor-computer interaction. Doctors' control and patients allow silence for the doctor to complete tasks often involving the computer and also for time out from the consultation. There is a clear pattern of when doctors need most to have silence and consultation models should be developed that reflect this need.
Background: Anaemia is a known risk factor for cardiovascular disease and treating anaemia in chronic kidney disease (CKD) may improve outcomes. However, little is known about the scope to improve primary care management of anaemia in CKD. Methods. An observational study (N = 1,099,292) with a nationally representative sample using anonymised routine primary care data from 127 Quality Improvement in CKD trial practices (ISRCTN5631023731). We explored variables associated with anaemia in CKD: eGFR, haemoglobin (Hb), mean corpuscular volume (MCV), iron status, cardiovascular comorbidities, and use of therapy which associated with gastrointestinal bleeding, oral iron and deprivation score. We developed a linear regression model to identify variables amenable to improved primary care management. Results: The prevalence of Stage 3-5 CKD was 6.76%. Hb was lower in CKD (13.2 g/dl) than without (13.7 g/dl). 22.2% of people with CKD had World Health Organization defined anaemia; 8.6% had Hb d 11 g/dl; 3% Hb d 10 g/dl; and 1% Hb d 9 g/dl. Normocytic anaemia was present in 80.5% with Hb d 11; 72.7% with Hb d 10 g/dl; and 67.6% with Hb d 9 g/dl; microcytic anaemia in 13.4% with Hb d 11 g/dl; 20.8% with Hb d 10 g/dl; and 24.9% where Hb d 9 g/dl. 82.7% of people with microcytic and 58.8% with normocytic anaemia (Hb d 11 g/dl) had a low ferritin (60% of people with normocytic anaemia. Prescribing oral iron has not corrected anaemia. © 2013 Dmitrieva et al.; licensee BioMed Central Ltd.
Treatment options for type 2 diabetes are becoming increasingly complex with people often prescribed multiple medications, and may include both oral and injectable therapies. There is ongoing debate about which drug classes provide the optimum second-line and third-line treatment options. In the real world, patient adherence and persistence determines medication effectiveness. A better understanding of adherence may help inform the choice of second-line and third-line drug classes.This systematic review will compare adherence and persistence rates across the different classes of medication available to people with type 2 diabetes. It will include all identified studies comparing medication adherence or persistence between two or more glucose-lowering medications in people with type 2 diabetes. Research databases (MEDLINE, EMBASE, The Cochrane Library, The Register of Controlled Trials, PsychINFO and CINAHL) will be searched for relevant articles, using a comprehensive search strategy. All identified medication trials and observational studies will be included which compare adherence or persistence across classes of diabetes medication. The characteristics and outcomes of all the included studies will be reported along with a study quality grade, assessed using the Cochrane Risk Assessment Tool. The quality of adjustment for confounders of adherence or persistence will be reported for each study. Where multiple (n e3) studies provide compare adherence or persistence across the same 2 medication classes, a meta-analysis will be performed.No ethics approval is required. This review and meta-analysis (where possible) will provide important information on the relative patient adherence and persistence, with the different classes of diabetes therapies. Once complete, the results will be made available by peer-reviewed publication.CRD42015027865.
de Lusignan S, Cashman J, Poh N, Michalakidis G, Mason A, Desombre T, Krause P (2012) Conducting Requirements Analyses for Research using Routinely Collected Health Data: a Model Driven Approach., Stud Health Technol Inform 180 pp. 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.
de Lusignan S (2011) SNOMED is coming, and more about using and interacting with technology in primary care., Inform Prim Care 19 (1) pp. 1-2
de Lusignan S, Andreasson AN, Pearce C, Ntasioudis A, Jones S (2011) Redesigning descriptions of work, protocols, and clinical trials documentation for quality improvement and research in computerised health services: a model driven approach,
Butler L, McGovern AP, de Lusignan S, Jones S (2013) Postnatal monitoring for diabetes following gestational diabetes in the UK, DIABETIC MEDICINE 30 (Supplement S1) pp. 171-171 WILEY-BLACKWELL
de Lusignan S, van Weel C (2006) The use of routinely collected computer data for research in primary care: opportunities and challenges., Fam Pract 23 (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.
de Lusignan S, Wells S, Thiru K (2000) Stopping antihypertensive drugs in general practice - Response, BRITISH JOURNAL OF GENERAL PRACTICE 50 (454) pp. 407-408 ROYAL COLL GENERAL PRACTITIONERS
Stevens PE, O'Donoghue DJ, de Lusignan S, Walker M, Van Vlymen J, Middleton R, Dzregah B, Farmer CK (2005) Identification of CKD from interrogation of primary care electronic patient records: Factors predicting level of and decline in estimated GFR, NEPHROLOGY DIALYSIS TRANSPLANTATION 20 pp. V287-V288 OXFORD UNIV PRESS
In England, guidance from National Institute for Clinical Excellence (NICE) states women with a family history of breast cancer presenting to primary care should be reassured or referred.We reviewed the evidence for interventions that might be applied in primary care and conducted an audit of whether low risk women are correctly advised and flagged.
McGovern A, Rafiq M, Munro N, Butler L, Russell-Jones D, Jones S, Hinchcliffe R, de Lusignan S (2013) 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
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.
Krause P, de Lusignan S (2010) Procuring interoperability at the expense of usability: a case study of UK National Programme for IT assurance process., Studies in Health Technology and Informatics: Seamless care, safe care: the challenges of interoperability and patient safety in health care: Proceedings of the EFMI Special Topic Conference 155 pp. 143-149
The allure of interoperable systems is that they should improve patient safety and make health services more efficient. The UK's National Programme for IT has made great strides in achieving interoperability; through linkage to a national electronic spine. However, there has been criticism of the usability of the applications in the clinical environment.
de Lusignan S, Navarro R, Chan T, Parry G, Dent-Brown K, Kendrick T (2011) Detecting referral and selection bias by the
anonymous linkage of practice, hospital and
clinic data using Secure and Private Record
Linkage (SAPREL): case study from the evaluation
of the Improved Access to Psychological Therapy
(IAPT) service, BMC Medical Informatics and Decision Making 11
UK primary care is highly computerized; initially led by enthusiastic general practitioners who developed their own systems. This preceded the development of a National Health Service information strategy and an ambitious National Programme for IT.
Sadek K, Khunti K, de Lusignan S (2012) Classification of Diabetes for Primary Care: A Practical Approach, Diabetes & Primary Care 14 (5, 2012) SB Communications Group
De Lusignan S, Wells S, Thiru K (2000) Letter to the editor, British Journal of General Practice 50 (454) pp. 407-408
Woodman J, Allister J, Rafi I, de Lusignan S, Belsey J, Petersen I, Gilbert R (2012) A simple approach to improve recording of concerns about child maltreatment in primary care records: developing a quality improvement intervention., British Journal of General Practice
de Lusignan S, Seroussi B (2013) A Comparison of English and French Approaches to Providing Patients Access to Summary Care Records: Scope, Consent, Cost, Studies in Health Technology and Informatics 186 pp. 61-65 IOS Press
Much of the knowledge management (KM) literature suggests that organizations should adopt either a "personalization" or "codification" strategy and that to mix the two is unwise. Two European schools have come to the conclusion that a broad strategy is needed. Its key conceptual elements are in three dimensions: the type (explicit - tacit), focus (information - learning) and organization (digital - social) of knowledge. Without this broad approach it is impossible to reconcile the wish to provide (codified) evidence-based solutions to populations at the same time as personalized care for individuals.
de Lusignan S (2009) Flagging fasting plasma glucose specimens: time to routinely label the context in which pathology specimens are recorded., Inform Prim Care 17 (2) pp. 63-64
Gomez GB, de Lusignan S, Gallagher H (2006) Chronic kidney disease: a new priority for primary care., Br J Gen Pract 56 (533) pp. 908-910
Mcgovern AP, Hinton W, van Vlymen J, Munro N, Whyte M, de Lusignan S (2016) Real-world evidence on prescribing trends in sodium glucose cotransporter 2 inhibitors in UK primary care, DIABETIC MEDICINE 33 pp. 165-165 WILEY-BLACKWELL
Murray J, Saxena S, Millett C, Curcin V, de Lusignan S, Majeed A (2010) Reductions in risk factors for secondary prevention of coronary heart disease by ethnic group in south-west London: 10-year longitudinal study (1998-2007)., Fam Pract 27 (4) pp. 430-438
To explore trends by ethnicity in clinical risk factor recording and control among patients with coronary heart disease (CHD), during a period of major investment in quality improvement initiatives in general practice in England.
de Lusignan S (2005) The barriers to clinical coding in general practice: a literature review., Med Inform Internet Med 30 (2) pp. 89-97
Clinical coding is variable in UK general practice. The reasons for this remain undefined. This review explains why there are no readily available alternatives to recording structured clinical data and reviews the barriers to recording structured clinical data. Methods used included a literature review of bibliographic databases, university health informatics departments, and national and international medical informatics associations. The results show that the current state of development of computers and data processing means there is no practical alternative to coding data. The identified barriers to clinical coding are: the limitations of the coding systems and terminologies and the skill gap in their use; recording structured data in the consultation takes time and is distracting; the level of motivation of primary care professionals; and the priority within the organization. A taxonomy is proposed to describe the barriers to clinical coding. This can be used to identify barriers to coding and facilitate the development of strategies to overcome them.
de Lusignan S, Teasdale S, Little D, Zapp J, Zuckerman A, Bates DW, Steele A (2004) Comprehensive computerised primary care records are an essential component of any national health information strategy: report from an international consensus conference., Inform Prim Care 12 (4) pp. 255-264
In many countries, primary care informatics has developed to the point that it is recognised as an important enabler of quality improvement; this has not occurred to date in the United States. With this conference, we aimed to build an international consensus as to whether primary care has unique characteristics that require an informatics subspecialty; and, if so, to establish the role of primary care informatics in improving patient care, and to enable its recognition in the national strategy.The conference was organised by the primary care informatics working groups of AMIA, EFMI, IMIA and Wonca and took place at Medinfo 2004 in San Francisco. It consisted of two plenary lectures, two small-group work sessions and a panel discussion to summarise the day. It was attended by an international audience of 53 health informaticians, mostly working in primary care. There was consensus among the participants that primary care has many unique characteristics that justify the existence of an informatics subspecialty: primary care informatics (PCI). The conference identified principles and practical examples of: (1) the effective deployment of information technology to underpin the provision of records, communication and access to information; (2) the need to harness the extensive knowledge base about the practice of PCI; and (3) the contribution of the experimental work and theory that underpins the science of PCI. These principles and examples of their practical application were largely derived from the extensive knowledge base which has been built up in countries that have developed PCI over the last one to two decades.
de Lusignan S (2008) Using routinely collected patient data with and without consent: trust and professionalism., Inform Prim Care 16 (4) pp. 251-254
de Lusignan S, Wells S, Johnson P, Meredith K, Leatham E (2001) Compliance and effectiveness of 1 year's home telemonitoring. The report of a pilot study of patients with chronic heart failure., Eur J Heart Fail 3 (6) pp. 723-730
UNLABELLED: Patients with a diagnosis of heart failure, registered at the study practice, were recruited into the study. First, they had a cardiologist's assessment. They were then randomised into telemonitored patients who measured pulse, BP, weight and video consulted, and controls. AIM: To examine the acceptability, effectiveness and reliability of home telemonitoring. RESULTS: A high proportion of those invited took part (n=20/24). Compliance with measuring weight, pulse and BP remained high throughout the study. The data collection system and secure web-server were reliable. The telemonitoring group complied better with collecting prescriptions for their cardiac drugs. Video consulting started with enthusiasm, but became less useful. There were no significant differences in the quality of life (GHQ) and Chronic Heart Failure (Guyatt) questionnaire scores between the telemonitored group and the controls. CONCLUSIONS: Home telemonitoring is an acceptable reliable intervention. Baseline rates for compliance with self-monitoring are set out in this study. Benefit in terms of compliance with medication and self-monitoring is still seen after 1 year. Video consulting over ordinary telephone lines did not show sustained benefit, and was not complied with.
Seidu S, Davies MJ, Mostafa S, de Lusignan S, Khunti K (2014) Prevalence and characteristics in coding, classification and diagnosis of diabetes in primary care, Postgraduate Medical Journal 90 (1059) pp. 13-17
Introduction Approximately 366 million people worldwide live with diabetes and this figure is expected to rise. Among the correct diagnosis, there will be errors in the diagnosis, classification and coding, resulting in adverse health and financial implications. Aim To determine the prevalence and characteristics of diagnostic errors in people with diabetes managed in primary care settings. Methods We conducted a cross-sectional study in nine general practices in Leicester, UK, from May to August 2011, using a validated electronic toolkit. Searches identified cases with potential errors which were manually checked for accuracy. Results There were 54 088 patients and 2434 (4.5%) diagnosed with diabetes. Out of 316 people identified with potential errors with the toolkit, 180 (57%) had confirmed errors after manually reviewing the records, resulting in an error prevalence of 7.4%. Correctly coded people on registers had significantly greater glycated haemoglobin (HbA1c) reductions. There were no significant differences between patients with and without errors in their HbA1C, body mass index, age and size of practice. There was also no significant association of the errors with pay-for-performance initiatives; however, those patients not on disease register had worse glycaemic control. Conclusions A high prevalence of diabetic diagnostic errors was confirmed using medication, biochemical and demographic data. Larger studies are needed to more accurately assess the scale of this problem. Automation of these processes might be possible, which would allow searches to be even more user friendly.
de Lusignan S, Brown A (1998) Internet can be accessed from NHSnet., BMJ 317 (7168)
de Lusignan S (2012) Time for research networks to be trained in informatics and based within informatics centres., Inform Prim Care 20 (1) pp. 3-5
Robinson J, de Lusignan S, Kostkova P, Madge B, Southgate L (2006) Specific classification of elibrary resources says more about users' preferences., Stud Health Technol Inform 124 pp. 719-724
BACKGROUND: Medical Subject Headings (MeSH) are a hierarchical taxonomy of over 42,000 descriptors designed to classify scientific literature; it is hierarchical with generic high order headings and specific low order headings. Over 1,000 resources in the Primary Care Electronic Library (PCEL - www.pcel.info
) were classified with MeSH. METHODS: Each of the entries or resources in the primary care digital library was assigned up to five MeSH terms. We compared whether the most generic or specific MeSH term ascribed to each resource best predicted user preferences. RESULTS: over the four month period analysed statistically significant differences were found for resources according to specific key MeSH terms they were classified by. This result was not repeated for generic key MeSH terms. CONCLUSIONS: Analysis of the use of specific MeSH terms reveals user preferences that would have otherwise remained obscured. These preferences are not found if more generic MeSH terms are analysed.
de Lusignan S (2014) First free-to-publish and free-full-text online volume completed., Informatics in primary care 21 (4) pp. 1-3
Dmitrieva O, Michalakidis G, Mason A, Jones S, Chan T, de Lusignan S (2012) Consistent Data Recording across a Health System and Web-Enablement Allow Service Quality Comparisons: Online Data for Commissioning Dermatology Services., Stud Health Technol Inform 174 pp. 84-88
de Lusignan S, Wells S (2002) Is the lack of emphasis on learning a barrier to the effective deployment of informatics? Content analysis of NHS strategy and information strategy since 1998?, AMIA 2002 SYMPOSIUM, PROCEEDINGS pp. 1005-1005 HANLEY & BELFUS INC MED PUBLISHERS
Alharbi NS, Almutari R, Jones S, Al-Daghr N, Khunti K, de Lusignan S (2014) Trends in the prevalence of type 2 diabetes mellitus and obesity in the Arabian Gulf States: systematic review and meta-analysis, Diabetes Research and Clinical Practice 106 (2) pp. e30-e33 Elsevier
We report trends in type 2 diabetes mellitus and obesity in adults residing in the Arabian Gulf States. Among the Saudi population, the prevalence of diabetes increased from 10.6% in 1989 to 32.1% in 2009. Prevalence of the disease increased faster among Saudi men than women, with growth rates of 0.8% and 0.6% per year, respectively.
de Lusignan S (2010) Looking beyond the National Programme for IT in primary care informatics., Inform Prim Care 18 (2) pp. 79-80
de Lusignan S (2015) Journal of Innovation in Health Informatics: building on the 20-year history of a BCS Health peer review journal., J Innov Health Inform 22 (1) pp. 152-152 BCS, The Chartered Institute for IT
After 20-years as Informatics in Primary Care the journal is renamed Journal of Innovation in Health Informatics. The title was carefully selected to reflect that: (1) informatics provides the opportunity to innovate rather than simply automates; (2) implementing informatics solutions often results in unintended consequences, and many implementations fail and benefits and innovations may go unrecognised; (3) health informatics is a boundary spanning discipline and is by its very nature likely to give rise to innovation. Informatics is an innovative science, and informaticians need to innovate across professional and discipline boundaries.
Mcgovern AP, Rusholme B, de Lusignan S, van Vlymen J, Jones S (2013) The interrelationship between hypertension, chronic kidney disease and proteinuria in people with diabetes: a cohort study, DIABETIC MEDICINE 30 (Supplement S1) pp. 28-28 WILEY-BLACKWELL
© 2016 Diabetes UK. Aims: To describe the proportion of glucose tests with unrecorded provenance in routine primary care data and identify the impact on clinical practice. Methods: A cross-sectional analysis was conducted of blood glucose measurements from the Royal College of General Practitioner Research and Surveillance Centre database, which includes primary care records from >100 practices across England and Wales. All blood glucose results recorded during 2013 were identified. Tests were grouped by provenance (fasting, oral glucose tolerance test, random, none specified and other). A clinical audit in a single primary care practice was also performed to identify the impact of failing to record glucose provenance on diabetes diagnosis. Results: A total of 2 137 098 people were included in the cross-sectional analysis. Of 203 350 recorded glucose measurements the majority (117 893; 58%) did not have any provenance information. The most commonly reported provenance was fasting glucose (75 044; 37%). The distribution of glucose values where provenance was not recorded was most similar to that of fasting samples. The glucose measurements of 256 people with diabetes in the audit practice (size 11 514 people) were analysed. The initial glucose measurement had no provenance information in 164 cases (64.1%). A clinician questioned the provenance of a result in 41 cases (16.0%); of these, 14 (34.1%) required repeating. Lack of provenance led to delays in the diagnosis of diabetes [median (range) 30 (3-614) days]. Conclusions: The recording of glucose provenance in UK primary care could be improved. Failure to record provenance causes unnecessary repeated testing, delayed diagnosis and wasted clinician time.
De Lusignan S (2011) Making health information and communications technology (ICT) relevant and usable for quality improvement and research, Informatics in Primary Care 19 (4) pp. 187-188
Carr-Bains S, de Lusignan S (2003) Moving to paperlessness: a case study from a large general practice., Inform Prim Care 11 (3) pp. 157-163
This case study reports the reasons why this large, multi-site general practice decided to move towards paperless practice in late 2001, and describes the progress and lessons learned to date. The principal operational reasons for this decision were problems associated with moving paper medical records between surgeries, and the realisation that resources to improve the computerised medical record could only come from redeploying the time spent handling paper records. A comprehensive plan was put in place to shift toward paperlessness. Motivating and changing working practices for clinical and support staff was as a great a challenge as upgrading the technology. The practice upgraded its computer system, and has installed scanning and automated generation of referral and other letters. The support staff skills have evolved from moving records to scanning documents and coding data. All clinical staff now consult on their computer, and code diagnoses and key clinical data. A networked digital dictation system allows typing to be centralised at one location, with the networking allowing printing at any site. Audit and quality improvement activities have increased, as the output from computer searches increasingly represents the quality of care provided. The implications of this case study are that a committed general practice can achieve a largely paperless environment in approximately two years. The practice is now fit to be part of any move towards integration of records within its local health community, and can demonstrate from its computer records that it meets the quality targets for primary care.
Woodman J, Rafi I, de Lusignan S (2014) Child maltreatment: time to rethink the role of general practice., Br J Gen Pract 64 (626) pp. 444-445
Mcgovern AP, Rusholme B, de Lusignan S, van Vlymen J, Jones S (2013) People with diabetes and unmonitored renal function are at increased risk of an adverse outcome: a cohort study, DIABETIC MEDICINE 30 (Supplement S1) pp. 28-29 WILEY-BLACKWELL
De Lusignan S (2005) The barriers to clinical coding in general practice: A literature review, Informatics for Health and Social Care 30 (2) pp. 89-97
Clinical coding is variable in UK general practice. The reasons for this remain undefined. This review explains why there are no readily available alternatives to recording structured clinical data and reviews the barriers to recording structured clinical data. Methods used included a literature review of bibliographic databases, university health informatics departments, and national and international medical informatics associations. The results show that the current state of development of computers and data processing means there is no practical alternative to coding data. The identified barriers to clinical coding are: the limitations of the coding systems and terminologies and the skill gap in their use; recording structured data in the consultation takes time and is distracting; the level of motivation of primary care professionals; and the priority within the organization. A taxonomy is proposed to describe the barriers to clinical coding. This can be used to identify barriers to coding and facilitate the development of strategies to overcome them. © 2005 Informa UK Ltd All rights reserved.
Theadom A, de Lusignan S, Wilson E, Chan T (2003) Using three-channel video to evaluate the impact of the use of the computer on the patient-centredness of the general practice consultation., Inform Prim Care 11 (3) pp. 149-156
The aim of this study was to assess the feasibility of using three-channel video to explore the impact of the computer on general practitioner (GP) consultations. A previous study had highlighted the limitations of using single-channel video: firstly, there was a lack of information about exactly how the computer was being used, and secondly difficulty in interpreting the body language of the consulting clinician. More information was needed to understand the impact of the computer on the consultation, and in this pilot three-channel video was used to overcome these constraints. Four doctors consulted, with the patient's role played by an actor with a preset script and preloaded personal and family history record programmed into the computer. The output was analysed using the Roter Interaction Analysis System (RIAS) and observational methods were used to explore the effect of computers on aspects of verbal and non-verbal behaviour and the completeness of the computer data record. Three-channel video proved to be a feasible and valuable technique for the analysis of primary care GP consultations, with advantages over single-channel video. Interesting differences in non-verbal and verbal behaviour became apparent with different types of computer use during the consultation. Implications for the three-channel video technique for training, monitoring GP competence and providing feedback are discussed.
de Lusignan S (2012) Coding the present problem., Inform Prim Care 20 (3) pp. 147-149
McGovern AP, Hinton W, Tippu Z, Whyte MB, de Lusignan S (2016) Ethnic disparities in medication persistence for Type 2 diabetes: non-whites have reduced persistence., American Diabetes Association
de Lusignan S (2010) Computerised routinely collected primary care data: essential for patient access to records, quality improvement and research., Inform Prim Care 18 (1) pp. 5-7
De Lusignan S, Chan T, Cohen A, Thana L, Dhoul N, Hague N, Van Vlymen J (2005) Health education and prevention for people with severe mental illness: A cross-sectional study of general practice computer records, Primary Care Mental Health 3 (3) pp. 221-233
Background: Although UK general practice is highly computerised and data from it have been widely used for quality improvement and research in many diseases areas, most data about the prevalence and quality of management of mental illness come from secondary care-based studies. Many of these studies suggest that people with mental health problems have an excess of cardiovascular and respiratory disease. Objective: We carried out this study to determine whether routinely collected general practice data are of sufficient quality to be used for quality improvement, health service planning and research. Setting: Twelve computerised general practices in West Surrey with a combined list size of 117 000 patients. Method: Audit criteria were developed within a primary care research network. A data set was identified which would enable quality of care to be assessed. MIQUEST (Morbidity Information and Export Syntax - a Department of Health-sponsored data extraction application) was used to extract anonymised data, which was transferred to a relational database and then analysed using a statistical package. Results: The standardised prevalence of cardiovascular and respiratory disease for the population was 1.73%. Respiratory disease was more common in people with severe mental illness (SMI); 22.6% had respiratory illness, compared with 16.4%. Patients with SMI and coronary heart disease (CHD) were much less likely to have their cholesterol measured. Low-density lipoprotein cholesterol (LDL) was measured about half as frequently in both groups, with no significant difference found. There was less use of lipid-lowering therapy where only 61.4% of people with SMI and CHD are taking a statin compared with 74.4% of those without (Ç2 = 0.01.) Mean systolic blood pressure (BP) in people with SMI was 133.6 mmHg. People with SMI and CHD were no more likely to be ex- or current smokers; the percentages of each group who were likely current or ex-smokers were 43.3% and 43.7% respectively. Across all age groups people with SMI were recoaaed as receiving more health promotion advice than people without SMI - advice about smoking, alcohol, diet and exercise. Women with SMI were no more or less likely to have a cervical smear or mammogram performed than those without SMI. Conclusions: General practice data suggest that there may be higher levels of mental health problems than reported in other studies. People with mental health problems have higher levels of cardiovascular and re
De Lusignan S (2010) Miscoding, misclassification and misdiagnosis, Diabetes and Primary Care 12 (3)
New JP, Middleton RJ, Klebe B, Farmer CK, de Lusignan S, Stevens PE, O'Donoghue DJ (2007) Assessing the prevalence, monitoring and management of chronic kidney disease in patients with diabetes compared with those without diabetes in general practice., Diabet Med 24 (4) pp. 364-369
AIMS: To compare rates of chronic kidney disease (CKD) in patients with diabetes and management of risk factors compared with people without diabetes using general practice computer records, and to assess the utility of serum creatinine and albuminuria as markers of impaired renal function. METHODS: The simplified Modification of Diet in Renal Disease (MDRD) equation was used to estimate glomerular filtration rate (eGFR) and stage of CKD. Further data were extracted to assess how effectively impaired renal function was being identified and how well potentially modifiable risk factors were being managed. The setting was 17 practices in Surrey, Kent and Greater Manchester (2003-2004). Participants were all patients with serum creatinine (SCr) recorded. RESULTS: Of the total population of 162 113, 5072 were recorded as having a diagnosis of diabetes, giving a prevalence of 3.1%. Of patients with diabetes, 31% had clinically significant CKD (defined as eGFR 120 micromol/l. Of patients with diabetes with eGFR 140/80 mmHg), 26% were not prescribed any hypertensive medication, regardless of level of CKD. CONCLUSIONS: CKD is common in people with diabetes living in the community in the UK. The study found a similar rate of stage 3-5 CKD to that found previously in the USA. Currently used measures of renal function fail to identify CKD as effectively as eGFR. Risk factors for CKD and its progression are suboptimally managed.
de Lusignan S, Wells S, Russell C (2003) A model for patient-centred nurse consulting in primary care., Br J Nurs 12 (2) pp. 85-90
A model for patient-centred nurse consulting, developed in the context of secondary prevention of cardiovascular disease, is reported in this article. The model was created in the absence of any existing model for nurse consulting. Heart disease clinics are increasingly being used to implement the National Service Framework for Coronary Heart Disease and it is anticipated that this model will be of practical use to nurses running these clinics. The model consists of eight steps, broadly following the chronology of the consultation. Each step contains a question for the nurse to ask him/herself and a task to complete. The model was developed as part of a research project on the influence of customized computer software used on nurse consultations with patients with heart disease.
de Lusignan S, Krause P (2010) Liberating the NHS: an information revolution--think beyond the electronic patient record, think service orientated architecture!, Inform Prim Care 18 (3) pp. 147-148
Dawson I, Senior V, de Lusignan S (2012) Perceptions of risk may explain the discrepancy between patient and clinician-recorded symptoms., Prim Care Respir J
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.
Liyanage H, Liaw ST, Kuziemsky C, Terry AL, Jones S, Soler JK, de Lusignan S (2013) The Evidence-base for Using Ontologies and Semantic Integration Methodologies to Support Integrated Chronic Disease Management in Primary and Ambulatory Care: Realist Review. Contribution of the IMIA Primary Health Care Informatics WG., Yearbook of Medical Informtics, 2013 1 pp. 147-154
ackground: 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 con- tribute 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. Objective: To describe the evidence base for using ontologies and other semantic integration methods to support chronic disease management. Method: We reviewed the evidence-base for the use of ontologies and other semantic integration methods within and across the elements of the CCM. We report them using a realist review describing the context in which the mechanism was applied, and any outcome measures.
Results: Most evidence was descriptive with an almost complete absence of empirical research and important gaps in the evidence-base. We found some use of ontologies and semantic integration methods for community support of the medical home and for care in the community. Ubiquitous information technology (IT) and other IT tools were deployed to support self-management support, use of shared registries, health behavioural models and knowledge discovery tools to improve delivery system design. Data quality issues restricted the use of clinical data; however there was an increased use of interoperable data and health system integration. Conclusions: Ontologies and semantic integration methods are emergent with limited evidence-base for their implementation. However, they have the potential to integrate the disparate com- munity wide data sources to provide the information necessary for effective chronic disease management.
de Lusignan S, Nitsch D, Belsey J, Kumarapeli P, Vamos EP, Majeed A, Millett C (2011) Disparities in testing for renal function in UK primary care: cross-sectional study., Fam Pract
BACKGROUND: In the UK, explicit quality standards for chronic disease management, including for diabetes and chronic kidney disease (CKD), are set out National Service Frameworks and pay-for-performance indicators. These conditions are common with a prevalence of 4% and 5.4%, respectively. CKD is largely asymptomatic, detected following renal function testing and important because associated with increased mortality and morbidity, especially in people with diabetes and proteinuria. OBJECTIVES: To investigate who has their renal function tested and any association with age, sex, ethnicity and diabetes. METHOD: A cross-sectional survey in a primary care research network in south-west London (n = 220 721). The following data were extracted from routine data: age, gender, ethnicity, latest serum creatinine, diagnosis of diabetes and recording of proteinuria. We used logistic regression to explore any association in testing for CKD. RESULTS: People (82.1%) with diabetes had renal function and proteinuria tested; the proportion was much smaller (75 years and with diabetes were most likely to have been tested. Black [adjusted odds ratio (AOR) 2.1, 95% confidence interval (CI) 2.0-2.2] and south Asian (AOR 1.65, 95% CI 1.56-1.75) patients were more likely to be tested than whites. Those where ethnicity was not stated were the only group not tested more than whites. CONCLUSIONS: Quality improvement initiatives and equity audits, which include CKD should take account of disparities in renal function testing.
Gaps in computerized medical records and a lack of a systematic approach to data recording make progress towards achieving quality standards in primary care difficult to demonstrate. The aim of this study was to examine the effect of an educational intervention on data quality in primary care.
de Lusignan S (2010) Bibliometric analysis of primary care research, childhood obesity, the importance of understanding small area data and diabetes., Inform Prim Care 18 (4) pp. 217-218
de Lusignan S, Chan T, Jones S (2011) Large complex terminologies: more coding choice, but harder to find data--reflections on introduction of SNOMED CT (Systematized Nomenclature of Medicine--Clinical Terms) as an NHS standard., Inform Prim Care 19 (1) pp. 3-5
Howitt A, Clement S, de Lusignan S, Thiru K, Goodwin D, Wells S (2002) An evaluation of general practice websites in the UK., Fam Pract 19 (5) pp. 547-556
BACKGROUND: General practice websites are an emerging phenomenon, but there have been few critical evaluations of their content. Previously developed rating instruments to assess medical websites have been criticized for failing to report their reliability and validity. OBJECTIVES: The purpose of this study was to develop a rating instrument for assessing UK general practice websites, and then to evaluate them critically. METHODS: The STaRNet Website Assessment Tool (SWAT) was developed listing criteria that general practice websites may meet, which was then used to evaluate a random sample of websites drawn from an electronic database. A second assessor rated a subsample of the sites to assess the tool's inter-rater reliability. The setting was an information technology group of a general practice research network using a random sample of 108 websites identified from the database. The main outcome measures were identification of rating criteria and frequency counts from the website rating instrument. RESULTS: Ninety (93.3%) sites were accessible, of which 84 were UK general practice websites. Criteria most frequently met were those describing the scope of the website and their functionality. Apart from e-mail to practices, criteria related to electronic communication were rarely met. Criteria relating to the quality of information were least often met. Inter-rater reliability kappa values for the items in the tool ranged from -0.06 to 1.0 (mean 0.59). Values were >0.6 for 15 out of 25 criteria assessed in 40 sites which were rated by two assessors. CONCLUSIONS: General practice websites offer a wide range of information. They are technically satisfactory, but do not exploit fully the potential for electronic doctor-patient communication. The quality of information they provide is poor. The instrument may be developed as a template for general practices producing or revising their own websites.
Sheeler I, Koczan P, Wallage W, de Lusignan S (2007) Low-cost three-channel video for assessment of the clinical consultation., Inform Prim Care 15 (1) pp. 25-31
Single-channel video is an established method for assessing the clinical consultation; however, it has limitations. While previous research has concluded that three-channel video recording of clinical consultations offers advantages, using professional equipment made costs prohibitive. In this study we set out to establish whether the benefits of three-channel video could be achieved using low-budget consumer-level equipment. Using a kit assembled for around euro 1000, we produced three-channel video recordings of simulated consultations. We then showed single- and three-channel versions of the videos to a panel of health professionals and recorded their opinions regarding the quality of the material and the level of information presented. We found that our budget three-channel set-up provided the same advantages as professional three-channel video, while the cost and complexity of the process was minimal. It is now affordable as well as feasible to use a budget set-up three-channel video system for training clinicians and assessing the impact of the computer on the consultation.
De Lusignan S, Hague N, Yates C, Harvey M (2002) A case study from a Sussex Primary Care Group: Improving secondary prevention in coronary heart disease using an educational intervention, British Journal of Cardiology 9 (6)
An educational intervention was developed to try to raise both data quality standards and those of clinical care in the secondary prevention of coronary heart disease. The intervention was used within primary care organisations utilising their own clinical data and with primary care professionals learning from each other. A special tool (MIQUEST) was used to extract the clinical data. Anonymised data were then shared with the whole primary care organisation at six-monthly data quality workshops. Patients needing interventions were identified in individual practices and these practice visits were also used as learning opportunities. At the end of the study there was an increase in the recording of the diagnosis of ischaemic heart disease (IHD). The recording of blood pressure and its control also improved. The number of IHD patients not on aspirin was reduced. Measurement of cholesterol, prescription of statins and the giving of advice to smokers all increased. The increase was largest in the practices with the lowest baseline data. The study concluded that this primary care data quality programme could provide an educational environment within which primary care organisations could improve secondary prevention in coronary heart disease.
Faulconer ER, de Lusignan S (2004) An eight-step method for assessing diagnostic data quality in practice: chronic obstructive pulmonary disease as an exemplar., Inform Prim Care 12 (4) pp. 243-254
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is an important cause of mortality and morbidity. Its management is shifting from the secondary to the primary care setting. The quality of data is known to vary between practices, and individual practices need to be able to assess their data quality. OBJECTIVES: To measure the quality of diagnostic data in COPD. SUBJECTS: 10 975 patients registered with a computerised general practice in the south of England, and 190 patients likely to have COPD. METHODS: An eight-step method was developed: (1) research the expected prevalence of the diagnosis and define audit criteria; (2) find out how the diagnosis might be coded--look at the terminology and the codes presented by the computer interface; (3) examine the characteristics of the practice population; (4) calculate the prevalence and infer its reliability; (5) investigate the completeness; (6) accuracy; (7) currency and consistency; and (8) calculate sensitivity and positive predictive value of the data. RESULTS: The prevalence of COPD in the literature ranges between 3% and 10%. The coding for bronchitis and COPD is complex and it is easy to select an incorrect code. The test population is younger but of similar social class to the national average. The prevalence of COPD in this study was 1.3%. The data were incomplete and some were inaccurate; patients with COPD had to be identified from additional searches. The sensitivity of the use of the diagnostic code was 79%, and the positive predictive value 75.3%. CONCLUSIONS: The method provides a tool to help practices and localities assess their diagnostic data quality.
de Lusignan S, Gallagher H, Chan T, Thomas N, van Vlymen J, Nation M, Jain N, Tahir A, du Bois E, Crinson I, Hague N, Reid F, Harris K (2009) The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD) in primary care., Implementation Science 4 (39)
BACKGROUND: Chronic kidney disease (CKD) is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP) control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression DESIGN: Cluster randomised controlled trial (CRT) METHODS: This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education. The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices) powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD. A small group of practices (n = 4) will take part in an in-depth process evaluation. We will use time series data to examine the natural history of CKD in the community. Finally, we will conduct an economic evaluation based on a comparison of the cost effectiveness of each intervention. CLINICAL TRIALS REGISTRATION: ISRCTN56023731. ClinicalTrials.gov identifier.
Cooper A, Brew S, de Lusignan S (2002) The effectiveness of blood tests in detecting secondary osteoporosis or mimicking conditions in postmenopausal women., Br J Gen Pract 52 (477) pp. 311-313
The National Service Framework for Older People requires a reduction in the number of falls that result in serious injury. Those most at risk need to be identified, investigated in line with the Royal College of Physicians Clinical Guidelines and receive appropriate treatment. This report looks at the results of investigation of postmenopausal women diagnosed as having osteoporosis in primary care by forearm Dexa scanner (DTX200) and questions whether the investigations suggested within the National Service Framework are justifiable. Scans were performed on 699 postmenopausal women aged 54 or over resulting in a new diagnosis of osteoporosis in 173 women. Complete blood tests were performed in 107 of the newly diagnosed patients. Only three of these patients (2.8%) had blood test results that revealed a potential secondary cause. The rates of positive findings are low; further research is needed to see if they are justified in postmenopausal women.
de Lusignan S, Krause P, Michalakidis G, Tristan Vicente M, Thompson S, Gilchrist M, Sullivan F, van Royen P, Agreus L, Desombre T, Taweel A, Delaney B (2012) Business Process Modelling is an Essential Part of a Requirements Analysis., IMIA Yearbook of Medical Informatics 2012
Liaw ST, Rahimi A, Ray P, Taggart J, Dennis S, de Lusignan S, Jalaludin B, Yeo AET, Talaei-Khoei A (2013) Towards an ontology for data quality in integrated chronic disease management: A realist review of the literature, International Journal of Medical Informatics 82 (1) pp. 10-24
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. © 2012 Elsevier Ireland Ltd.
Pluskiewicz W, Drozdzowska B, Halaba Z, Harvey M, De Lusignan S, Versluis RGJA (2002) Osteoporosis in postmenopausal women (multiple letters), British Journal of General Practice 52 (479) pp. 496-498
Rafiq M, McGovern A, Jones S, Harris K, Tomson C, Gallagher H, de Lusignan S (2014) Falls in the elderly were predicted opportunistically using a decision tree and systematically using a database-driven screening tool., 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.
Mold F, Ellis B, de Lusignan S, Sheikh A, Wyatt JC, Cavill M, Michalakidis G, Barker F, Majeed A, Quinn T, Koczan P, Avanitis T, Gronlund TA, Franco C, McCarthy M, Renton Z, Chauhan U, Blakey H, Kataria N, Jones S, Rafi I (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, Informatics In Primary Care 20 (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.
Kumarapeli P, Stepaniuk R, de Lusignan S, Williams R, Rowlands G (2006) Ethnicity recording in general practice computer systems., J Public Health (Oxf) 28 (3) pp. 283-287
BACKGROUND: Ethnicity data in general practice (GP) computerized medical records can be utilized to audit equity in health care. METHODS: We evaluated a patient profiling project targeted to improve ethnicity recording. RESULTS: Data extracted from 16 practices showed an increase in ethnicity recording from
De Lusignan S (2012) Informatics research, practice, theory and history, Informatics in Primary Care 19 (3) pp. 125-126
Kumarapeli P, De Lusignan S, Ellis T, Jones B (2007) Using Unified Modelling Language (UML) as a process-modelling technique for clinical-research process improvement, Informatics for Health and Social Care 32 (1) pp. 51-64
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.
de Lusignan S, Tomson C, Harris K, van Vlymen J, Gallagher H (2012) UK Prevalence of Chronic Kidney Disease for the Adult Population Is 6.76% Based on Two Creatinine Readings., Nephron Clin Pract 120 (2)
No abstract available.
Stevens PE, O'Donoghue DJ, de Lusignan S, Van Vlymen J, Klebe B, Middleton R, Hague N, New J, Farmer CK (2007) Chronic kidney disease management in the United Kingdom: NEOERICA project results., Kidney Int 72 (1) pp. 92-99
Early identification of patients with chronic kidney disease (CKD) may allow health-care systems to implement interventions aimed at decreasing disease progression and eventual morbidity and mortality. Primary care in the United Kingdom is computerized suggesting a separate screening program for CKD may not be necessary because identifying data already populates primary care databases. Our study utilized a data set of 163 demographic, laboratory, diagnosis, and prescription variables from 130 226 adults in the regions of Kent, Manchester, and Surrey. The patients were 18 years of age and older in a 5-year study period culminating in November 2003. Estimated glomerular filtration rate was calculated from the four-variable Modification of Diet in Renal Disease equation using calibrated creatinine levels. A valid creatinine value was recorded in almost 30% of this cohort. The age-standardized prevalence of stage 3-5 CKD was 10.6% for females and 5.8% for males. In these patients, the odds ratio for hypertension was 2.1, for diabetes 1.33, and for cardiovascular disease 1.69. Only 20% of the diabetic people with stage 3-5 CKD had a blood pressure less than or equal to 130/80 mm Hg. The proportion of patients with anemia significantly rose as renal function declined. We suggest that stage 3-5 CKD is easily detected in existing computerized records. The associated comorbidity and management is readily available enabling intervention and targeting of specialist resources.
de Lusignan S (2003) Commentary: Improve the quality of the consultation., BMJ 326 (7382) pp. 202-206
Pearce C, Shachak A, Kushniruk A, de Lusignan S (2009) Usability: a critical dimension for assessing the quality of clinical systems., Inform Prim Care 17 (4) pp. 195-198
Robinson J, de Lusignan S, Kostkova P, Madge B (2006) Using UMLS to map from a library to a clinical classification: Improving the functionality of a digital library., Stud Health Technol Inform 121 pp. 86-95
The Metathesaurus of the Unified Medical Language System (UMLS) offers the possibility of mapping between various medical vocabularies. The Primary Care Electronic Library (PCEL) contains a database of over six thousand Medical Subject Headings (MeSH terms) describing the resources of the electronic library. We were interested to know if it was possible to map from MeSH to the Systemized Nomenclature of Medicine Clinical Terms (SNOMED CT). Such a mapping would aid healthcare professionals to retrieve relevant data from our digital library as it would enable links between clinical systems and indexed material.
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.
Liyanage HS, Luzi D, de Lusignan S, Pecoraro F, McNulty R, Tamburis O, Krause P, Rigby M, Blair M (2016) Accessible Modelling of Complexity in Health and associated data flows: asthma as an exemplar, Journal of Innovation in Health Informatics 23 (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.
de Lusignan S, Ellis B (2005) Is the time right for direct entry into a career in health and biomedical informatics?, Inform Prim Care 13 (3) pp. 167-170
Michalakidis G, Kumarapeli P, Ring A, van Vlymen J, Krause P, de Lusignan S (2010) A system for solution-orientated reporting of errors associated with the extraction of routinely collected clinical data for research and quality improvement., Studies in Health Technology and Informatics: Proceedings of the 13th World Congress on Medical Informatics 160 (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.
Leong A, Koczan P, De Lusignan S, Sheeler I (2006) A framework for comparing video methods used to assess the clinical consultation: a qualitative study., Med Inform Internet Med 31 (4) pp. 255-265
BACKGROUND: Single-channel video is an established method for assessing clinical consultation in training general practitioners; however, it is hard to infer the body language of the doctor or how information in the consultation is being integrated into the medical record. A three-channel video was developed combining the conventional view with a camera looking at the doctor's facial expression and copying the video output from the monitor. However, the choice of three channels and camera angles selected has not been critically appraised. OBJECTIVE: To develop criteria for comparing single and multi-channel approaches to video recording of the consultation. METHODS: Single channel and three-channel recordings of simulated consultations were shown to a panel of 12 health professionals and interviews were conducted to gather their opinions on the level of information presented, quality and assessment. The transcripts were analysed thematically. RESULTS: It was found that in providing visual information the three-channel video was superior to the single channel video. The major elements needed for comparison of the two techniques would be the ability of the video to pick up quantifiable non-verbal communication of the doctor and the patient, and the ability to qualitatively and quantitatively reflect the use and impact of the computer on the consultation. The information provided by the three-channel video could be further classified to essential, desirable and redundant to guide the future development of the multi-channel video. CONCLUSIONS: Multi-channel methods should be able to capture the following information: body language and facial expression of doctor and patient; and how the doctor's knowledge and information collected in the consultation are synthesized into the medical record.
BACKGROUND: In the UK, chronic disease, including chronic kidney disease (CKD) is largely managed in primary care. We developed a tool to assess practitioner confidence and knowledge in managing CKD compared to other chronic diseases. This questionnaire was part of a cluster randomised quality improvement interventions in chronic kidney disease (QICKD; ISRCTN56023731). METHODS: The questionnaire was developed by family physicians, primary care nurses, academics and renal specialists. We conducted three focus groups (n=7, 6, and 8) to refine the questionnaire using groups of general practitioners, practice nurses and trainees in general practice. We used paper based versions to develop the questionnaire and online surveys to test it. Practitioners in a group of volunteer, trial practices received the questionnaire twice. We measured its reliability using Cohen's Kappa (K). RESULTS: The practitioners in the focus groups reached a consensus as to the key elements to include in the instrument. We achieved a 73.1% (n=57/78) initial response rate for our questionnaire; of these 57, 54 completed the questionnaire a second time. Family physicians made up the largest single group of respondents (47.4%, n=27). Initial response showed more female (64.9%, n=37) than male (35.1%, n=20) respondents. The reliability results from retesting showed that there was moderate agreement (k>0.4) on all questions; with many showing substantial agreement (k>0.6). There was substantial agreement in the questions about loop diuretics (k=0.608, CI 0.432-0.784, p
Cases of chronic kidney disease (CKD) are defined by the estimated glomerular filtration rate (eGFR), calculated using the Modified Diet in Renal Disease (MDRD) or, more recently, the CKD Epidemiology Collaboration (CKD-EPI) formula. This study set out to promote a systematic approach to reporting CKD prevalence. DESIGN, SETTING, PARTICIPANTS AND MEASUREMENTS: The study explores the impact of the way in which eGFR is calculated on the prevalence of CKD. We took into account whether including (1) ethnicity, (2) using a single eGFR, (3) using more than 1 eGFR value or (4) using the CKD-EPI formula affected the estimates of prevalence.
Hinton W, McGovern AP, Whyte MB, Curtis BH, McCullough K, van Brunt K, Calderara S, de Lusignan S (2016) What are the HbA1c thresholds for initiating insulin therapy in people with type 2 diabetes in UK primary care?, European Association for Study Diabetes
McGovern AP, Hine J, de Lusignan S (2016) Infection risk in elderly people with reduced glycaemic control, The Lancet Diabetes & Endocrinology 4 (4) pp. 303-304 Elsevier
Refers to: Jonathan Pearson-Stuttard, Samkeliso Blundell, Tess Harris, Derek G Cook, Julia Critchley
Diabetes and infection: assessing the association with glycaemic control in population-based studies
The Lancet Diabetes & Endocrinology, Volume 4, Issue 2, February 2016, Pages 148-158
Mold F, de Lusignan S, Sheikh A, Majeed A, Wyatt JC, Quinn T, Cavill M, Gronlund TA, Franco C, Chauhan U, Blakey H, Kataria N, Barker F, Ellis B, Koczan P, Avanitis TA, McCarthy M, Jones S, Rafi I (2015) Patients? online access to their electronic health records and linked online services: a systematic review, British Journal of General Practice 65 (632) pp. e141-e151 Royal College of General Practitioners
Background Online access to medical records by patients can potentially enhance provision of patient-centred care and improve satisfaction. However, online access and services may also prove to be an additional burden for the healthcare provider.
Aim To assess the impact of providing patients with access to their general practice electronic health records (EHR) and other EHR-linked online services on the provision, quality, and safety of health care.
Design and setting A systematic review was conducted that focused on all studies about online record access and transactional services in primary care.
Method Data sources included MEDLINE, Embase, CINAHL, Cochrane Library, EPOC, DARE, King?s Fund, Nuffield Health, PsycINFO, OpenGrey (1999?2012). The literature was independently screened against detailed inclusion and exclusion criteria; independent dual data extraction was conducted, the risk of bias (RoB) assessed, and a narrative synthesis of the evidence conducted.
Results A total of 176 studies were identified, 17 of which were randomised controlled trials, cohort, or cluster studies. Patients reported improved satisfaction with online access and services compared with standard provision, improved self-care, and better communication and engagement with clinicians. Safety improvements were patient-led through identifying medication errors and facilitating more use of preventive services. Provision of online record access and services resulted in a moderate increase of e-mail, no change on telephone contact, but there were variable effects on face-to-face contact. However, other tasks were necessary to sustain these services, which impacted on clinician time. There were no reports of harm or breaches in privacy.
Conclusion While the RoB scores suggest many of the studies were of low quality, patients using online services reported increased convenience and satisfaction. These services positively impacted on patient safety, although there were variations of record access and use by specific ethnic and socioeconomic groups. Professional concerns about privacy were unrealised and those about workload were only partly so.
Poh N, de Lusignan S (2011) Data-modelling and visualisation in chronic kidney disease (CKD): a step towards personalised medicine., Inform Prim Care 19 (2) pp. 57-63
Personalised medicine involves customising management to meet patients' needs. In chronic kidney disease (CKD) at the population level there is steady decline in renal function with increasing age; and progressive CKD has been defined as marked variation from this rate of decline.
de Lusignan S (2003) Commentary: improve the quality of the consultation, BRITISH MEDICAL JOURNAL 326 (7382) pp. 205-206 BRITISH MED JOURNAL PUBL GROUP
Harvey M, De Lusignan S (2002) Osteoporosis in postmenopausal women., Br J Gen Pract 52 (479) pp. 496-497
de Lusignan S, Pebody R, Warburton F, Andrews N, Ellis J, von Wissman B, Robertson C, Yonova I, Cottrell S, Gallagher N, Green H, Thompson C, Galiano M, Marques D, Gunson R, Reynolds A, Moore C, Mullett D, Pathirannehelage S, Donati M, Johnston J, McMenamin J, Zambon M (2015) Effectiveness of trivalent seasonal influenza vaccine in preventing laboratory-confirmed influenza in primary care in the United Kingdom: 2014/15 end of season results, Eurosurveillance 20 (36) 15-00338 pp. 1-18
European Centre for Disease Prevention and Control
The 2014/15 influenza season in the United Kingdom (UK) was characterised by circulation of predominantly antigenically and genetically drifted influenza A(H3N2) and B viruses. A universal paediatric influenza vaccination programme using a quadrivalent live attenuated influenza vaccine (LAIV) has recently been introduced in the UK. This study aims to measure the end-of-season influenza vaccine effectiveness (VE), including for LAIV, using the test negative case?control design. The overall adjusted VE against all influenza was 34.3% (95% confidence interval (CI) 17.8 to 47.5); for A(H3N2) 29.3% (95% CI: 8.6 to 45.3) and for B 46.3% (95% CI: 13.9 to 66.5). For those aged under 18 years, influenza A(H3N2) LAIV VE was 35% (95% CI: ?29.9 to 67.5), whereas for influenza B the LAIV VE was 100% (95% CI:17.0 to 100.0). Although the VE against influenza A(H3N2) infection was low, there was still evidence of significant protection, together with moderate, significant protection against drifted circulating influenza B viruses. LAIV provided non-significant positive protection against influenza A, with significant protection against B. Further work to assess the population impact of the vaccine programme across the UK is underway.
Liyanage H, Correa A, Liaw ST, Kuziemsky C, Terry AL, de Lusignan S (2015) Does Informatics Enable or Inhibit the Delivery of Patient-centred, Coordinated, and Quality-assured Care: a Delphi Study. A Contribution of the IMIA Primary Health Care Informatics Working Group., Yearb Med Inform 10 (1) pp. 22-29
BACKGROUND: Primary care delivers patient-centred and coordinated care, which should be quality-assured. Much of family practice now routinely uses computerised medical record (CMR) systems, these systems being linked at varying levels to laboratories and other care providers. CMR systems have the potential to support care. OBJECTIVE: To achieve a consensus among an international panel of health care professionals and informatics experts about the role of informatics in the delivery of patient-centred, coordinated, and quality-assured care. METHOD: The consensus building exercise involved 20 individuals, five general practitioners and 15 informatics academics, members of the International Medical Informatics Association Primary Care Informatics Working Group. A thematic analysis of the literature was carried out according to the defined themes. RESULTS: The first round of the analysis developed 27 statements on how the CMR, or any other information system, including paper-based medical records, supports care delivery. Round 2 aimed at achieving a consensus about the statements of round one. Round 3 stated that there was an agreement on informatics principles and structures that should be put in place. However, there was a disagreement about the processes involved in the implementation, and about the clinical interaction with the systems after the implementation. CONCLUSIONS: The panel had a strong agreement about the core concepts and structures that should be put in place to support high quality care. However, this agreement evaporated over statements related to implementation. These findings reflect literature and personal experiences: whilst there is consensus about how informatics structures and processes support good quality care, implementation is difficult.
Statins are recommended for the secondary prevention of cardiovascular disease, although they are often used in suboptimal doses and some patients may not receive lipid-lowering therapy. The Primary Care Data Quality (PCDQ) programme is an audit-based educational intervention.
de Lusignan S, Chan T, Theadom A, Dhoul N (2007) The roles of policy and professionalism in the protection of processed clinical data: a literature review., Int J Med Inform 76 (4) pp. 261-268
BACKGROUND: Routinely collected clinical data is increasingly used for health service management, audit, and research. Even apparently anonymised data are subject to data protection. The relevant principles were set out in a treaty of the Council of Europe and subsequent policy has been based on these. However, little has been written about implementing policy and the role of health informaticians in this process. OBJECTIVE: To define the elements of an effective implementation policy; the role of the health informatician in protecting processed clinical data. METHODS: We performed a literature review of bibliographic databases, a manual search of the major medical informatics associations' websites, relevant working groups and an affiliated journal. Fifty-four papers relevant to implementation were identified. RESULTS: The effective implementation of policy requires consideration of technical, organisational, personnel and professional issues. However, there is no clearly defined formula for successful implementation of data protection policy. CONCLUSIONS: Patients and professionals need a system they can trust, and processes that can be easily incorporated into everyday practice. The lack of a core generalisable theory or strong professional code in health informatics limits the ability of the health informaticians to implement policy.
de Lusignan S (2003) What is primary care informatics?, J Am Med Inform Assoc 10 (4) pp. 304-309
Primary care informatics is an emerging academic discipline that remains undefined. The unique nature of primary care necessitates the development of its own informatics discipline. A definition of primary care informatics is proposed, which encompasses the distinctive nature of primary care. The core concepts and theory that should underpin it are described. Primary care informatics is defined as a science and as a subset of health informatics. The proposed definition is intended to focus the development of a generalizable core theory for this informatics subspecialty.
de Lusignan S (2012) The health information ecosystem, technology to support more effective hospital discharge, data quality enables prediction of outcomes, and supporting better decision making., Inform Prim Care 20 (2) pp. 77-79
de Lusignan S, Liaw ST, Dedman D, Khunti K, Sadek K, Jones S (2015) An algorithm to improve diagnostic accuracy in diabetes in computerised problem orientated medical records (POMR) compared with an established algorithm developed in episode orientated records (EOMR)., Journal of innovation in health informatics 22 (2) pp. 255-264 BCS, The Chartered Institute for IT
An algorithm that detects errors in diagnosis, classification or coding of diabetes in primary care computerised medial record (CMR) systems is currently available. However, this was developed on CMR systems that are episode orientated medical records (EOMR); and do not force the user to always code a problem or link data to an existing one. More strictly problem orientated medical record (POMR) systems mandate recording a problem and linking consultation data to them.To compare the rates of detection of diagnostic accuracy using an algorithm developed in EOMR with a new POMR specific algorithm.We used data from The Health Improvement Network (THIN) database (N = 2,466,364) to identify a population of 100,513 (4.08%) patients considered likely to have diabetes. We recalibrated algorithms designed to classify cases of diabetes to take account of that POMR enforced coding consistency in the computerised medical record systems [In Practice Systems (InPS) Vision] that contribute data to THIN. We explored the different proportions of people classified as having type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) and with diabetes unclassifiable as either T1DM or T2DM. We compared proportions using chi-square tests and used Tukey's test to compare the characteristics of the people in each group.The prevalence of T1DM using the original EOMR algorithm was 0.38% (9,264/2,466,364), and for T2DM 3.22% (79,417/2,466,364). The prevalence using the new POMR algorithm was 0.31% (7,750/2,466,364) T1DM and 3.65% (89,990/2,466,364) T2DM. The EOMR algorithms also left more people unclassified 11,439 (12%), as to their type of diabetes compared with 2,380 (2.4%), for the new algorithm. Those people who were only classified by the EOMR system differed in terms of older age, and apparently better glycaemic control, despite not being prescribed medication for their diabetes (p
BACKGROUND: A gene-based estimate of lung cancer risk in smokers has been shown to act as a smoking cessation motivator in hospital recruited subjects. The objective of this trial is to determine if this motivator is as effective in subjects recruited from an NHS primary care unit. METHOD/DESIGN: Subjects will be recruited by mailings using smoking entries on the GP electronic data-base (total practice population = 32,048) to identify smokers who may want to quit. Smoking cessation clinics based on medical centre premises will run for eight weeks. Clinics will be randomised to have the gene-based test for estimation of lung cancer risk or to act as controls groups. The primary endpoint will be smoking cessation at eight weeks and six months. Secondary outcomes will include ranking of the gene-based test with other smoking cessation motivators. DISCUSSION: The results will inform as to whether the gene-based test is both effective as motivator and acceptable to subjects recruited from primary care. TRIAL REGISTRATION: Registered with Clinical Trials.gov, REGISTRATION NUMBER: NCT01176383.
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.
Pearce C, Kumarpeli P, de Lusignan S (2010) Getting seamless care right from the beginning - integrating computers into the human interaction., Stud Health Technol Inform 155 pp. 196-202
The digital age is coming to the health space, behind many other fields of society. In part this is because health remains heavily reliant on human interaction. The doctor-patient relationship remains a significant factor in determining patient outcomes. Whilst there are many benefits to E-Health, there are also significant risks if computers are not adequately integrated into this interaction and accurate data are consequently not available on the patient's journey through the health system.
De Lusignan S, Dzregah B, Hague N, Chan T (2003) Cholesterol management in patients with IHD: An audit-based appraisal of progress towards clinical targets in primary care, British Journal of Cardiology 10 (3) pp. 223-228
Anonymised data collected from 24 participating localities in England have been aggregated for this report. The data are taken from general practice computer records using a validated extraction tool Morbidity Information Query and Export SynTax (MIQUEST). The number of patients with heart disease, a cholesterol measure, whether they had been prescribed a statin, their quality of control, and its implications are reported. In the population studied of 2.4 million, 89,422 patients had a diagnosis of ischaemic heart disease; a prevalence rate of 3.7%. Cholesterol measurement was available for half (48.3%) of these patients, of whom half (55.2%) were taking a statin. As a result of this treatment gap, 118 excess myocardial infarctions annually are predicted, equivalent to around 7,150 events nationally. Compared to previous audits carried out in UK general practice, considerable progress has been made towards the achievement of treatment goals. The treatment gap is represented by a combination of lack of measurement and recording of data as well as poor quality of control.
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.
McGovern AP, Rusholme B, Jones S, van Vlyman JN, Liyanage H, Gallagher H, Tomson CR, Khunti K, Harris K, de Lusignan S (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., BMC Nephrol 14 (1)
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.
Hassan Sadek N, Sadek AR, Tahir A, Khunti K, Desombre T, de Lusignan S (2012) Evaluating tools to support a new practical classification of diabetes: excellent control may represent misdiagnosis and omission from disease registers is associated with worse control., The International Journal of Clinical Practice Blackwell Publishing Ltd
de Lusignan S, Pearce C, Munro N (2013) Getting on with your computer is associated with job satisfaction in primary care: entrants to primary care should be assessed for their competency with electronic patient record systems., Inform Prim Care 21 (1) pp. i-iii
Job satisfaction in primary care is associated with getting on with your computer. Many primary care professionals spend longer interacting with their computer than anything else in their day. However, the computer often makes demands rather than be an aid or supporter that has learned its user's preferences. The use of electronic patient record (EPR) systems is underrepresented in the assessment of entrants to primary care, and in definitions of the core competencies of a family physician/general practitioner. We call for this to be put right: for the use of the EPR to support direct patient care and clinical governance to be given greater prominence in training and assessment. In parallel, policy makers should ensure that the EPR system use is orientated to ensuring patients receive evidence-based care, and EPR system suppliers should explore how their systems might better support their clinician users, in particular learning their preferences.
de Lusignan S (2011) International lessons in clinical quality and evaluation, Informatics in Primary Care 18 (3) pp. 145-146
Liyanage HS, Liaw S-T, Di Iorio CT, Kuziemsky C, Schreiber R, Terry AL, de Lusignan S (2016) Building a Privacy, Ethics, and Data Access Framework for Real World Computerised Medical Record System Data: A Delphi Study, IMIA Yearbook of Medical Informatics 2016 pp. 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.
de Lusignan S, Althans A, Wells S, Johnson P, Vandenburg M, Robinson J (2000) A pilot study of radiotelemetry for continuous cardiopulmonary monitoring of patients at home, J TELEMED TELECARE 6 (1) pp. 119-122 ROYAL SOC MEDICINE PRESS
We have conducted a trial of a wireless device for continuous cardiopulmonary monitoring. Its
performance, user acceptance and safety were assessed for monitoring in the patient?s home. The
study included 20 patients: six with chronic obstructive pulmonary disease, six with chronic heart
failure, seven with atrial fibrillation and palpitations, and one with a snoring problem. The system
recorded the heart rate and respiratory rate, blood pressure, electrocardiogram and body temperature.
The results were transmitted automatically to a central monitoring station. The accuracy of the
measurements was checked by a comparison system and also by conventional measurements
performed by a nurse. The system was acceptable to patients and functioned satisfactorily in the home.
An important facet of home telemonitoring may turn out to be its greater reliability in collecting
McGovern A, Woodman J, Allister J, Van Vlymen J, Liyanage H, Jones S, Rafi I, De Lusignan S, Gilbert R (2015) A simple clinical coding strategy to improve recording of child maltreatment concerns: An audit study, Informatics in Primary Care 22 (1) pp. 227-234 BCS, The Chartered Institute for IT
Copyright © 2014 The Author(s). Background: Recording concerns about child maltreatment, including minor concerns, is recommended by the General Medical Council (GMC) and National Institute for Health and Clinical Excellence (NICE) but there is evidence of substantial under-recording. Aim: To determine whether a simple coding strategy improved recording of maltreatment-related concerns in electronic primary care records. Design and Setting: Clinical audit of rates of maltreatment-related coding before January 2010-December 2011 and after January-December 2012 implementation of a simple coding strategy in 11 English family practices. The strategy included encouraging general practitioners to use, always and as a minimum, the Read code 'Child is cause for concern'. A total of 25,106 children aged 0-18 years were registered with these practices. We also undertook a qualitative service evaluation to investigate barriers to recording. Method: Outcomes were recording of 1) any maltreatment-related codes, 2) child protection proceedings and 3) child was a cause for concern. Results: We found increased recording of any maltreatment-related code (rate ratio 1.4; 95% CI 1.1-1.6), child protection procedures (RR 1.4; 95% CI 1.1-1.6) and cause for concern (RR 2.5; 95% CI 1.8-3.4) after implementation of the coding strategy. Clinicians cited the simplicity of the coding strategy as the most important factor assisting implementation. Conclusion: This simple coding strategy improved clinician's recording of maltreatment-related concerns in a small sample of practices with some '?buy-in'. Further research should investigate how recording can best support the doctor-patient relationship.
McGovern AP, Hinton W, van Vlymen J, Munro N, Whyte M, de Lusignan S (2016) Real-world evidence on the disparities in prescribing of dipeptidylpeptidase-4 inhibitors in UK primary care, DIABETIC MEDICINE 33 pp. 183-183 WILEY-BLACKWELL
Woodman J, de Lusignan S, Rafi I, Allister J, Gilbert R (2012) GPs' role in safeguarding children., BMJ (Clinical research ed.) 345
Poh N, de Lusignan S, Liyanage H, van Vlymen J, Krause P, Jones S (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., Stud Health Technol Inform 192 pp. 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.
Gallagher H, de Lusignan S, Harris K, Cates C (2010) Quality-improvement strategies for the management of hypertension in chronic kidney disease in primary care: a systematic review., Br J Gen Pract 60 (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.
de Lusignan S, Hall S, Kulendran M, Sadek AR, Green S (2011) Variability in selecting patients to manage in the
community: a service evaluation of community
matron?s case-finding strategies, Family Practice 28 (4)
Wahl S, Drong A, Lehne B, Loh M, Scott WR, Kunze S, Tsai P-C, Ried JS, Zhang W, Yang Y, Tan S, Fiorito G, Franke L, Guarrera S, Kasela S, Kriebel J, Richmond RC, Adamo M, Afzal U, Ala-Korpela M, Albetti B, Ammerpohl O, Apperley JF, Beekman M, Bertazzi PA, Lucas Black S, Blancher C, Bonder MJ, Brosch M, Carstensen-Kirberg M, de Craen AJM, de Lusignan S (2016) Epigenome-wide association study of body mass index, and the adverse outcomes of adiposity, Nature 541 pp. 81-86 Nature Publishing Group
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
. Although the mechanisms linking adiposity to
associated clinical conditions are poorly understood, recent studies
suggest that adiposity may influence DNA methylation3?6, a key
regulator of gene expression and molecular phenotype7
. Here we
use epigenome-wide association to show that body mass index
(BMI; a key measure of adiposity) is associated with widespread
changes in DNA methylation (187 genetic loci with P
to 6.0×10?46; n=10,261 samples). Genetic
association analyses demonstrate that the alterations in DNA
methylation are predominantly the consequence of adiposity,
rather than the cause. We find that methylation loci are enriched
for functional genomic features in multiple tissues (P
show that sentinel methylation markers identify gene expression
signatures at 38 loci (P
, range P = 5.5 × 10?6
6.1×10?35, n=1,785 samples). The methylation loci identify genes
involved in lipid and lipoprotein metabolism, substrate transport
and inflammatory pathways. Finally, we show that the disturbances
in DNA methylation predict future development of type 2 diabetes
(relative risk per 1 standard deviation increase in methylation risk
score: 2.3 (2.07?2.56); P=1.1×10?54). Our results provide new
insights into the biologic pathways influenced by adiposity, and may
enable development of new strategies for prediction and prevention
of type 2 diabetes and other adverse clinical consequences of obesity
Seidu S, Davies M, Mostafa SA, de Lusignan S, Khunti K (2013) Prevalence and characteristics in coding, classification and diagnosis of diabetes in primary care, DIABETIC MEDICINE 30 (Supplement S1) pp. 190-190 WILEY-BLACKWELL
de Lusignan S, Sullivan F (2006) Integration, Interoperability or Linkage: Which Elements of National IT Strategy Best Support Primary Care?, INTEGRATING BIOMEDICAL INFORMATION: FROM E-CELL TO E-PATIENT pp. 79-84 AKADEMISCHE VERLAGSGESELLSCH AKA GMBH
Shaw A, de Lusignan S, Rowlands G (2005) Do primary care professionals work as a team: a qualitative study., J Interprof Care 19 (4) pp. 396-405
Teamworking is a vital element in the delivery of primary healthcare. There is evidence that well organised multidisciplinary teams are more effective in developing quality of care. Personal Medical Services (PMS) is a health reform that allows general practices more autonomy and flexibility in delivering quality based primary care. Practices in the locality where this study was conducted were offered resources to employ additional staff. Such arrangements provided the opportunity to expand and develop Primary Care Teams. In this qualitative study, semi-structured interviews were conducted with primary care professionals in 21 second wave PMS practices. Some participants felt they had used PMS to build their teams and develop quality based patient care. For other practices teamworking was limited by the absence of a common goal, recruitment difficulties, inadequate communication and hierarchical structures, and prevented practices from moving forward with clear direction. The study indicates that changing the contractual arrangements does not necessarily improve teamworking. It highlights the need for more sustained educational and quality improvement initiatives to encourage greater collaboration and understanding between healthcare professionals.
The annual stroke rate in atrial fibrillation is around 5 per cent with increased risk in those with hypertension, diabetes, left ventricular dysfunction and other cardiovascular risk factors. This study set out to identify the patients with atrial fibrillation and modifiable risk factors for stroke.
Williams B, Shaw A, Durrant R, Crinson I, Pagliari C, de Lusignan S (2005) Patient perspectives on multiple medications versus combined pills: a qualitative study., QJM 98 (12) pp. 885-893
BACKGROUND: A growing number of patients are taking multiple medications. Unfortunately, adherence may fall as drug numbers and procedural complexity increase. While there are plausible theoretical reasons why combining pills might improve non-adherence, patients' attitudes are unknown. AIM: To explore attitudes and practices to medication regimens among patients already in receipt of multiple medications, and to assess whether a combined tablet would be perceived as advantageous. DESIGN: Qualitative study. METHODS: Ninety-two men and women aged >40 years currently receiving both antihypertensive and cholesterol-lowering medications took part in 14 focus groups. RESULTS: Drugs were seen as unwelcome but necessary. Some took drugs flexibly by changing dose timing, thereby increasing the complexity of their regimen. A routine was seen as the key to coping with multiple medications, although it was sometimes threatened by changes in prescriptions and life circumstances. While some participants welcomed a combined pill, there was uncertainty about whether a combination that mirrored their current doses would be available. There were also concerns about tablet size, allergies, the attribution of side-effects, timing of tablets throughout the day, and the ability to alter dose levels. CONCLUSION: While some patients would be willing to try a combined pill and would appreciate the associated convenience, they are likely to have a number of concerns that prescribers should address. Willingness to move to combined therapy may be hindered if drug combinations that mirror personalized and trusted regimens are not available.
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.
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.
De Lusignan S, Shaw A, Wells S, Rowlands G (2005) Why do some practices innovate: A qualitative study of the views of primary care professionals, Clinician in Management 13 (3-4) pp. 135-143
Background: The Personal Medical Services (PMS) contract is an innovation which allows general practices to provide locally sensitive, quality-based primary care, unlike the traditional contract based on a complex formula of fees. Aim: To determine from the primary care professionals in 33 second-wave PMS practices their perceptions of the factors associated with both positive outcomes and also with slow progress. Design: A qualitative study, adopting an iterative thematic approach. Method: Semi-structured interviews were conducted with one practice nurse, practice manager and general practitioner from each practice. Interview transcripts were analysed for emerging themes using QSR N-VIVO software. Results: Analysis of the interviews revealed a general enthusiasm for PMS by the primary care professionals. They felt that critical success factors included the provision of additional clinical staff, and a cohesive, communicative team with a visionary leader and good management systems. The perceived barriers to progress were inadequate premises and the difficulty in recruiting and retaining staff. Conclusion: PMS provides a framework for quality orientated, locally sensitive care. In the best practices it allows the development of services that cross the health and social care divide. © 2005 Radcliffe Publishing.
de Lusignan S, Thiru K, Wells S, Dobson M, Howitt A (2000) Overcoming the constraints to becoming paperless., Br J Gen Pract 50 (455) pp. 504-505
Refsum C, Kumarapeli P, Gunaratne A, Dodds R, Hasan A, de Lusignan S (2008) Measuring the impact of different brands of computer systems on the clinical consultation: a pilot study., Inform Prim Care 16 (2) pp. 119-127
UK general practitioners largely conduct computer-mediated consultations. Although historically there were many small general practice (GP) computer suppliers there are now around five widely used electronic patient record (EPR) systems. A new method has been developed for assessing the impact of the computer on doctor-patient interaction through detailed observation of the consultation and computer use.
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.
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.
Crinson I, Shaw A, Durrant R, De Lusignan S, Williams B (2007) Coronary heart disease and the management of risk: Patient perspectives of outcomes associated with the clinical implementation of the National Service Framework targets, HEALTH RISK & SOCIETY 9 (4) pp. 359-373 ROUTLEDGE JOURNALS, TAYLOR & FRANCIS LTD
Appleton A, Sadek K, Dawson IG, de Lusignan S (2012) Clinicians were oblivious to incorrect logging of test dates and the associated risks in an online pathology application: a case study., Inform Prim Care 20 (4) pp. 241-247
UK primary care physicians receive their laboratory test results electronically. This study reports a computerised physician order entry (CPOE) system error in the pathology test request date that went unnoticed in family practices.
Liaw ST, Pearce C, Liyanage H, Liaw GSS, De Lusignan S (2014) An integrated organisation-wide data quality management and information governance framework: Theoretical underpinnings, Informatics in Primary Care 21 (4) pp. 199-206
Copyright © 2014 The Author(s).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 efficiencyand 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.
Liaw ST, Taggart J, Yu H, Lusignan SD, Kuziemsky C, Hayen A (2014) Integrating electronic health record information to support integrated care: Practical application of ontologies to improve the accuracy of diabetes disease registers, Journal of Biomedical Informatics 52 pp. 364-372
© 2014 Elsevier Inc. Background: Information in Electronic Health Records (EHRs) are being promoted for use in clinical decision support, patient registers, measurement and improvement of integration and quality of care, and translational research. To do this EHR-derived data product creators need to logically integrate patient data with information and knowledge from diverse sources and contexts. Objective: To examine the accuracy of an ontological multi-attribute approach to create a Type 2 Diabetes Mellitus (T2DM) register to support integrated care. Methods: Guided by Australian best practice guidelines, the T2DM diagnosis and management ontology was conceptualized, contextualized and validated by clinicians; it was then specified, formalized and implemented. The algorithm was standardized against the domain ontology in SNOMED CT-AU. Accuracy of the implementation was measured in 4 datasets of varying sizes (927-12,057 patients) and an integrated dataset (23,793 patients). Results were cross-checked with sensitivity and specificity calculated with 95% confidence intervals. Results: Incrementally integrating Reason for Visit (RFV), medication (Rx), and pathology in the algorithm identified nearly100% of T2DM cases. Incrementally integrating the four datasets improved accuracy; controlling for sample size, data incompleteness and duplicates. Manual validation confirmed the accuracy of the algorithm. Conclusion: Integrating multiple data elements within an EHR using ontology-based case-finding algorithms can improve the accuracy of the diagnosis and compensate for suboptimal data quality, and hence creating a dataset that is more fit-for-purpose. This clinical and pragmatic application of ontologies to EHR data improves the integration of data and the potential for better use of data to improve the quality of care.
McGovern A, van Vlymen J, Liyanage L, de Lusignan S, Jones S, Woodman J, Gibert R, Allister J, Rafi I (2014) A simple clinical coding strategy to improve recording of child maltreatment concerns: an audit study, British Journal of General Practice 625 pp. 389-390
Recording concerns about child maltreatment, including minor concerns, is recommended by the General Medical Council (GMC)1 and National Institute for health and Care Excellence (NICE)2 but there is evidence of substantial under-recording.3,4 GPs are apprehensive about how recording is perceived by parents and the impact of this on the patient?doctor relationship.4 However, careful clinical coding, even of minor concerns, is essential for building a cumulative picture of concerns and making children ?findable? on the system.
Anandarajah S, Tai T, de Lusignan S, Stevens P, O'Donoghue D, Walker M, Hilton S (2005) The validity of searching routinely collected general practice computer data to identify patients with chronic kidney disease (CKD): a manual review of 500 medical records., Nephrol Dial Transplant 20 (10) pp. 2089-2096
BACKGROUND: We conducted a search of 12 practices' routinely collected computer data in three localities across the UK and found that 4.9% of the registered population had an estimated glomerular filtration rate (GFR) of
Williams PH, de Lusignan S (2006) Does a higher 'quality points' score mean better care in stroke? An audit of general practice medical records., Inform Prim Care 14 (1) pp. 29-40
BACKGROUND: The Royal College of Physicians (RCP) have produced guidelines for stroke management in primary care; this guidance is taken to be the gold standard for the care of people with stroke. UK general practitioners now have a quality-based contract which includes a Quality and Outcomes Framework (QOF). This consists of financially remunerated 'quality points' for specific disease areas, including stroke. Achievement of these quality points is measured by extracting a limited list of computer codes from practice computer systems. OBJECTIVES: To investigate whether a high stroke quality score is associated with adherence to RCP guidelines. DESIGN: Examination of computer and written medical records of all patients with a diagnosis of stroke. SETTING: Two general practices, one in southwest London, one in Surrey, with a combined practice population of over 20 000. Both practices had a similar age-sex profile and prevalence of stroke. RESULTS: One practice scored 93.5% (29/31) of the available stroke quality points. The other practice achieved 73.4% (22.75/31), and only did better in one stroke quality target. However, the practice scoring fewer quality points had much better adherence to RCP guidance: 96% of patients were assessed in secondary care compared with 79% (P=0.001); 64% of stroke patients were seen the same day, compared with 44%; 56% received rehabilitation compared with 37%. CONCLUSIONS: Higher quality points did not reflect better adherence to RCP guidance. This audit highlights a gap between relatively simplistic measures of quality in the QOF, dependent on the recording of a narrow range of computer codes, and the actual standard of care being delivered. Research is needed to see whether this finding is generalisable and how the Quality and Outcomes Framework might be better aligned with delivering best practice.
Brownrigg JRW, Hughes CO, Burleigh D, Karthikesalingam A, Patterson BO, Holt PJ, Thompson MM, de Lusignan S, Ray KK, Hinchliffe RJ (2016) Microvascular disease and risk of cardiovascular events among individuals with type 2 diabetes: a population-level cohort study, The Lancet Diabetes & Endocrinology 4 (7) pp. 588-597
Diabetes confers a two times excess risk of cardiovascular disease, yet predicting individual risk remains challenging. The effect of total microvascular disease burden on cardiovascular disease risk among individuals with diabetes is unknown.
A population-based cohort of patients with type 2 diabetes from the UK Clinical Practice Research Datalink was studied (n=49?027). We used multivariable Cox models to estimate hazard ratios (HRs) for the primary outcome (the time to first major cardiovascular event, which was a composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischaemic stroke) associated with cumulative burden of retinopathy, nephropathy, and peripheral neuropathy among individuals with no history of cardiovascular disease at baseline.Findings
During a median follow-up of 5·5 years, 2822 (5·8%) individuals experienced a primary outcome. After adjustment for established risk factors, significant associations were observed for the primary outcome individually for retinopathy (HR 1·39, 95% CI 1·09?1·76), peripheral neuropathy (1·40, 1·19?1·66), and nephropathy (1·35, 1·15?1·58). For individuals with one, two, or three microvascular disease states versus none, the multivariable-adjusted HRs for the primary outcome were 1·32 (95% CI 1·16?1·50), 1·62 (1·42?1·85), and 1·99 (1·70?2·34), respectively. For the primary outcome, measures of risk discrimination showed significant improvement when microvascular disease burden was added to models. In the overall cohort, the net reclassification index for USA and UK guideline risk strata were 0·036 (95% CI 0·017?0·055, p
The cumulative burden of microvascular disease significantly affects the risk of future cardiovascular disease among individuals with type 2 diabetes. Given the prevalence of diabetes globally, further work to understand the mechanisms behind this association and strategies to mitigate this excess risk are warranted.
Liyanage H, Liaw ST, Kuziemsky C, de Lusignan S (2013) Ontologies to improve chronic disease management research and quality improvement studies - a conceptual framework., Stud Health Technol Inform 192 pp. 180-184
There is a growing burden of chronic non-communicable disease (CNCD). Managing CNCDs requires use of multiple sources of health and social care data, and information about coordination and outcomes. Many people with CNCDs have multimorbidity. Problems with data quality exacerbate challenges in measuring quality and health outcomes especially where there is multimorbidity. We have developed an ontological toolkit to support research and quality improvement studies in CNCDs using heterogeneous data, with diabetes mellitus as an exemplar. International experts held a workshop meeting, with follow up discussions and consensus building exercise. We generated conceptual statements about problems with a CNCD that ontologies might support, and a generic reference model. There were varying degrees of consensus. We propose a set of tools, and a four step method: (1) Identification and specification of data sources; (2) Conceptualisation of semantic meaning; (3) How available routine data can be used as a measure of the process or outcome of care; (4) Formalisation and validation of the final ontology.
Thiru K, de Lusignan S, Hague N (1999) Have the completeness and accuracy of computer medical records in general practice improved in the last five years? the report of a two-practice pilot study, Health Informatics Journal 5 (4) pp. 224-232
Through its involvement in primary care groups (PCGs) general practice is destined to play a major role in the commissioning of UK National Health Service (NHS) services. If this objective is to be achieved then data will be required at PCG level from electronic patient records (EPRs). The aim of this study was to examine the completeness and accuracy of GP computer records over the last five years in two computerized practices. The objectives were: to establish whether data recording has improved; to discover whether cross-platform data extraction using MIQUEST (Morbidity Information Query Export Syntax) has advantages over the different in-system search tools provided in the EMIS and Meditel systems in our pilot practices; and to suggest how the potential of GP databases to be sources of valid data might be realized. we have demonstrated that high standards of data quality can be achieved in general practice and that there are benefits in using the cross-platform data extraction tool MIQUEST. While being vigilant of coding practices that may introduce systematic errors, data extractors should focus on data validation. We surmise that there are both human and technical barriers to achieving high quality data recording that need further research.
de Lusignan S, Minmagh C, Kennedy J, Zeimet M, Bommezijn H, Bryant J (2001) A survey to identify the clinical coding and classification systems currently in use across Europe., Stud Health Technol Inform 84 (Pt 1) pp. 86-89
INTRODUCTION: This is a survey to identify what clinical coding systems are currently in use across the European Union, and the states seeking membership to it. We sought to identify what systems are currently used and to what extent they were subject to local adaptation. BACKGROUND: Clinical coding should facilitate identifying key medical events in a computerised medical record, and aggregating information across groups of records. The emerging new driver is as the enabler of the life-long computerised medical record. A prerequisite for this level of functionality is the transfer of information between different computer systems. This transfer can be facilitated either by working on the interoperability problems between disparate systems or by harmonising the underlying data. This paper examines the extent to which the latter has occurred across Europe. METHOD: Literature and Internet search. Requests for information via electronic mail to pan-European mailing lists of health informatics professionals. RESULTS: Coding systems are now a de facto part of health information systems across Europe. There are relatively few coding systems in existence across Europe. ICD9 and ICD 10, ICPC and Read were the most established. However the local adaptation of these classification systems either on a by country or by computer software manufacturer basis; significantly reduces the ability for the meaning coded with patients computer records to be easily transferred from one medical record system to another. CONCLUSIONS: There is no longer any debate as to whether a coding or classification system should be used. Convergence of different classifications systems should be encouraged. Countries and computer manufacturers within the EU should be encouraged to stop making local modifications to coding and classification systems, as this practice risks significantly slowing progress towards easy transfer of records between computer systems.
Mold F, de Lusignan S (2015) Patients? Online Access to Their Primary Care Electronic Health Records and Linked Online Services: Implications for Research and Practice, Journal of Personalized Medicine 5 (4) pp. 452-469 MDPI AG
Online access to medical records and linked services, including requesting
repeat prescriptions and booking appointments, enables patients to personalize their access
to care. However, online access creates opportunities and challenges for both health
professionals and their patients, in practices and in research. The challenges for practice are
the impact of online services on workload and the quality and safety of health care. Health
professionals are concerned about the impact on workload, especially from email or other
online enquiry systems, as well as risks to privacy. Patients report how online access
provides a convenient means through which to access their health provider and may offer
greater satisfaction if they get a timely response from a clinician. Online access and services
may also result in unforeseen consequences and may change the nature of the patient-clinician
interaction. Research challenges include: (1) Ensuring privacy, including how to control
inappropriate carer and guardian access to medical records; (2) Whether online access to
records improves patient safety and health outcomes; (3) Whether record access increases
disparities across social classes and between genders; and (4) Improving efficiency. The
challenges for practice are: (1) How to incorporate online access into clinical workflow; (2)
The need for a business model to fund the additional time taken. Creating a sustainable business model for a safe, private, informative, more equitable online service is needed if
online access to records is to be provided outside of pay-for-service systems.
Carr H, de Lusignan S, Liyanage H, Liaw ST, Terry A, Rafi I (2014) Defining dimensions of research readiness: a conceptual model for primary care research networks., BMC Fam Pract 15 pp. 169-169
BACKGROUND: Recruitment to research studies in primary care is challenging despite widespread implementation of electronic patient record (EPR) systems which potentially make it easier to identify eligible cases. METHODS: Literature review and applying the learning from a European research readiness assessment tool, the TRANSFoRm International Research Readiness instrument (TIRRE), to the context of the English NHS in order to develop a model to assess a practice's research readiness. RESULTS: Seven dimensions of research readiness were identified: (1) Data readiness: Is there good data quality in EPR systems; (2) Record readiness: Are EPR data able to identify eligible cases and other study data; (3) Organisational readiness: Are the health system and socio-cultural environment supportive; (4) Governance readiness: Does the study meet legal and local health system regulatory compliance; (5) Study-specific readiness; (6) Business process readiness: Are business processes tilted in favour of participation: including capacity and capability to take on extra work, financial incentives as well as intangibles such as social and intellectual capital; (7) Patient readiness: Are systems in place to recruit patients and obtain informed consent? CONCLUSIONS: The model might enable the development of interventions to increase participation in primary care-based research and become a tool to measure the progress of practice networks towards the most advanced state of readiness.
de Lusignan S, Hague N, Belsey J, Dhoul N, van Vlymen J (2006) The 'rule of halves' still applies to the management of cholesterol in cardiovascular disease: 2002-2005, British Journal of Cardiology 13 (2) pp. 145-153
The current national target in the UK for total cholesterol is 5 mmol/L. The Primary Care Data Quality (PCDQ) programme reported in 2002 that only 50% of patients with coronary heart disease (CHD) achieved the 5 mmol/L target and we report on progress since then. Routinely collected general practice computer data were extracted in two successive data collections in 2003 and 2004/05 and analysed. The standardised prevalence of CHD recorded in GP computer systems rose from 3.8% to 4.0% from 2002 to 2004/5. In patients with CHD, cholesterol recording rose from 47.6% to 89.0%, the percentage of patients receiving a statin rose from 49.4% to 71.5% and mean cholesterol levels fell from 5.18 to 4.67 mmol/L. The proportion of CHD patients with a cholesterol recording achieving the 5 mmol/L target increased from 44.7% to 67.7%. Overall, 53.1 % of patients with cardiovascular disease had total cholesterol below 5 mmol/L. Patients with CHD achieved better cholesterol control than those with stroke (4.87 mmol/L) or peripheral vascular disease (PVD) (4.79 mmol/L) and a higher percentage of patients achieved the 5 mmol/L target (60.1% versus 43.3% and 49.9% respectively). There remains scope for improved management of cholesterol in primary care and greater efforts are needed to see that more patients with cardiovascular disease benefit from best practice.
de Lusignan S, Krause P (2010) The Hayes principles: learning from the national pilot of information technology and core generalisable theory in informatics., Inform Prim Care 18 (2) pp. 73-77
There has been much criticism of the NHS national programme for information technology (IT); it has been an expensive programme and some elements appear to have achieved little. The Hayes report was written as an independent review of health and social care IT in England.
Kousoulis AA, Rafi I, De Lusignan S (2015) The CPRD and the RCGP: Building on research success by enhancing benefits for patients and practices, British Journal of General Practice 65 (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.
de Lusignan S, Valentin T, Chan T, Hague N, Wood O, van Vlymen J, Dhoul N (2004) Problems with primary care data quality: osteoporosis as an exemplar., Inform Prim Care 12 (3) pp. 147-156
OBJECTIVE: To report problems implementing a data quality programme in osteoporosis. DESIGN: Analysis of data extracted using Morbidity Information Query and Export Syntax (MIQUEST) from participating general practices' systems and recommendations of practitioners who attended an action research workshop. SETTING: Computerised general practices using different Read code versions to record structured data. PARTICIPANTS: 78 practices predominantly from London and the south east, with representation from north east, north west and south west England. MAIN OUTCOME MEASURES: Patients at risk can be represented in many ways within structured data. Although fracture data exists, it is unclear which are fragility fractures. T-scores, the gold standard for measuring bone density, cannot be extracted using the UK's standard data extraction tool, MIQUEST; instead manual searches had to be implemented. There is a hundredfold variation in data recording levels between practices. Therapy is more frequently recorded than diagnosis. A multidisciplinary forum of experienced practitioners proposed that a limited list of codes should be used. CONCLUSIONS: There is variability in inter-practice data quality. Some clinically important codes are lacking, and there are multiple ways that the same clinical concept can be represented. Different practice computer systems have different versions of Read code, making some data incompatible. Manual searching is still required to find data. Clinicians with an understanding of what data are clinically relevant need to have a stronger voice in the production of codes, and in the creation of recommended lists.
de Lusignan S, Chan T, Parry G, Dent-Brown K, Kendrick T (2011) Referral to a new psychological therapy service is associated with reduced utilisation of healthcare and sickness absence by people with common mental health problems: A before and after comparison, Journal of Epidemiology and Community Health BMJ
Background Improving Access to Psychological
Therapies (IAPT) is a new programme designed to
reduce disease burden to the individual and economic
burden to the society of common mental health
problems (CMHP). This is the first study to look at the
impact of IAPT on health service utilisation and sickness
absence using routine data.
Method The authors used pseudonymised secure and
privately linked (SAPREL) routinely collected primary,
secondary care and clinic computer data from two pilot
localities. The authors explored antidepressant
prescribing, accident and emergency and outpatients
attendances, inpatient stays, bed days, and sick
certification. The authors compared the registered
population with those with CMHP. The authors then
made a 6 months before and after comparison of people
referred to IAPT with ageesex and practice-matched
Results People with CMHP used more health resources
than those without CMHP: more prescriptions of
antidepressants 5.25 (95% CI 5.38 to 5.13), inpatient
episodes 4.89 (95% CI 5.0 to 4.79), occupied bed days
1.25 (95% CI 0.95 to 1.55), outpatient 1.5 (95% CI 1.40
to 1.63) and emergency department attendances 0.34
(95% CI 0.31 to 0.37), and medical certificates 0.29
(95% CI 0.26 to 0.32). Comparison of service utilisation
6 months before and after referral to IAPT was
associated with reduced use of emergency department
attendances (mean difference: 0.12 (95% CI 0.06 to
of antidepressants increased mean difference 0.15
(95% CI 0.02 0.29, p¼0.028).
Conclusions People with CMHP use more healthcare
resources. Referral to the IAPT programme is associated
with a subsequent reduction in emergency department
attendances, sickness certification and improved
adherence to drug treatment.
Rollason W, Khunti K, de Lusignan S (2009) Variation in the recording of diabetes diagnostic data in primary care computer systems: implications for the quality of care., Inform Prim Care 17 (2) pp. 113-119
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.
Milner T, de Lusignan S, Jones S, Jackson P, Irvine T (2015) Breast cancer metastasis burden in sentinel nodes analysed using one-step nucleic acid amplification predicts axillary nodal status, The Breast
In breast cancer patients undergoing sentinel lymph node biopsy (SLNB) analysis using one-step nucleic acid amplification (OSNA), clarity is required as to the risk factors for non-sentinel lymph node (NSLN) involvement upon axillary lymph node dissection (ALND). This study aims to identify these factors, including categorising by extent of sentinel node positivity: solitary positive node (solitary), multiple nodes with some positive (multiple incomplete positive), or multiple nodes all of which are positive (multiple all positive).
We conducted a cohort study using prospectively collected data on 856 SLNBs analysed using OSNA, from patients with cT1-3 clinically node-negative invasive breast cancer. ALND was performed for 289 positive SLNBs.
NSLN metastases were identified in 73 (25.3%) ALNDs. Significant factors for NSLN involvement on multivariate analysis were: SLNB macrometastases (cytokeratin-19 mRNA count >5000 copies/¼l) (adj.OR = 3.01; 95% CI, 1.61?5.66; p = 0.0006), multiple all positive vs. multiple incomplete positive SLNB (adj.OR = 2.92; 95% CI, 1.38?6.19; p = 0.0050), and undergoing mastectomy (adj.OR = 1.89; 95% CI, 1.00?3.55; p = 0.0486). Amongst multiple incomplete positive SLNBs, an 8.8% NSLN risk was identified when only micrometastases were present.
Extent of sentinel lymph node positivity measured using OSNA predicts NSLN metastasis risk, aiding decisions surrounding axillary treatment.
Liyanage H, Liaw ST, Kuziemsky C, Terry AL, Jones S, Soler JK, de Lusignan S (2013) The Evidence-base for Using Ontologies and Semantic Integration Methodologies to Support Integrated Chronic Disease Management in Primary and Ambulatory Care: Realist Review. Contribution of the IMIA Primary Health Care Informatics WG., Yearb Med Inform 8 (1) pp. 147-154
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.
The use of health data for public health, surveillance, quality improvement and research is crucial to improve health systems and health care. However, bodies responsible for privacy and ethics often limit access to routinely collected health data. Ethical approvals, issues around protecting privacy and data access are often dealt with by different layers of regulations, making approval processes appear disjointed.To create a comprehensive framework for defining the ethical and privacy status of a project and for providing guidance on data access.The framework comprises principles and related questions. The core of the framework will be built using standard terminology definitions such as ethics-related controlled vocabularies and regional directives. It is built in this way to reduce ambiguity between different definitions. The framework is extensible: principles can be retired or added to, as can their related questions. Responses to these questions should allow data processors to define ethical issues, privacy risk and other unintended consequences.The framework contains three steps: (1) identifying possible ethical and privacy principles relevant to the project; (2) providing ethics and privacy guidance questions that inform the type of approval needed; and (3) assessing case-specific ethics and privacy issues. The outputs from this process should inform whether the balance between public interests and privacy breach and any ethical considerations are tipped in favour of societal benefits. If they are then this should be the basis on which data access is permitted. Tightly linking ethical principles to governance and data access may help maintain public trust.
Pflug B, Kumarapeli P, van Vlymen J, Ammenwerth E, de Lusignan S (2010) Measuring the impact of the computer on the consultation: an open source application to combine multiple observational outputs., Inform Health Soc Care 35 (1) pp. 10-24
A diverse range of tools and techniques can be used to observe the clinical consultation and the use of information technology. These technologies range from transcripts; to video observation with one or more cameras; to voice and pattern recognition applications. Currently, these have to be observed separately and there is limited capacity to combine them. Consequently, when multiple methods are used to analyse the consultation a significant proportion of time is spent linking events in one log file (e.g. mouse movements and keyboard use when prescribing alerts appear) with what was happening in the consultation at that time. The objective of this study was to develop an application capable of combining and comparing activity log-files and with facilities to view simultaneously all data relating to any time point or activity. Interviews, observations and design prototypes were used to develop a specification. Class diagram of the application design was used to make further development decisions. The application development used object-orientated design principles. We used open source tools; Java as the programming language and JDeveloper as the development environment. The final output is log file aggregation (LFA) tool which forms part of the wider aggregation of log files for analysis (ALFA) open source toolkit ( www.biomedicalinformatics.info/alfa/
). Testing was done using sample log files and reviewed the application's utility for analysis of the consultation activities. Separation of the presentation and functionality in the design stage enabled us to develop a modular and extensible application. The application is capable of converting and aggregating several log files of different formats and displays them in different presentation layouts. We used the Java Media Framework to aggregate video channels. Java extensible mark-up language (XML) package facilitated the conversion of aggregated output into XML format. Analysts can now move easily between observation tools and find all the data related to an activity. The LFA application makes new analysis tasks feasible and established tasks much more efficient. Researchers can now store multiple log file data as a single file isolate and investigate different doctor-computer-patient interaction.
Chan T, van Vlymen J, Dhoul N, de Lusignan S (2010) Using routinely collected data to evaluate a leaflet campaign to increase the presentation of people with memory problems to general practice: a locality based controlled study., Inform Prim Care 18 (3) pp. 189-196
The Alzheimer's Society wished to raise awareness that people with memory problems may benefit from early assessment and diagnosis, so that appropriate measures could be put in place and management improved.
Dawson I, Senior V, de Lusignan S (2012) Perceptions of risk may explain the discrepancy between patient and clinician-recorded symptoms, Primary Care Respiratory Journal 21 (2) pp. 124-126 Elsevier
De Lusignan S, Pearce C, Shaw NT, Liaw ST, Michalakidis G, Vicente MT, Bainbridge M (2011) What are the barriers to conducting international research using routinely collected primary care data?, Studies in Health Technology and Informatics 165 pp. 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. © 2011 European Federation for Medical Informatics. All rights reserved.
Johnson P, Andrews DC, Wells S, de Lusignan S, Robinson J, Vandenburg M (2001) The use of a new continuous wireless cardiorespiratory telemonitoring system by elderly patients at home., J Telemed Telecare 7 Suppl 1 pp. 76-77
The diagnosis and management of increasing numbers of patients with chronic diseases in the community require new technologies and strategies of care. We have used a new wireless cardiorespiratory telemonitoring system to monitor 14 elderly patients with a variety of chronic diseases at home. The electrocardiogram (ECG), heart rate and variability, and breathing were recorded on two separate occasions for 24 h. There was no difference in the data recorded when a research nurse applied the monitoring system and when the patients applied it themselves. The ECG and heart rate were recorded for 98% of the monitored time, and the frequency and periodicities of breathing were recorded for 74% and 61% of sleep and rest time by visual and automatic analysis, respectively. The results show that 24 h activity and cardiorespiratory telemonitoring can be performed by elderly patients at home. Significant unsuspected abnormalities of breathing and heart rhythm, amenable to treatment, were also detected.
Johnson P, Andrews DC, Wells S, de Lusignan S, Robinson J, Vandenburg M (2001) The use of a new continuous wireless cardiorespiratory telemonitoring system by elderly patients at home, JOURNAL OF TELEMEDICINE AND TELECARE 7 pp. S76-S77 ROYAL SOC MEDICINE PRESS LTD
de Lusignan S, Hague N, van Vlymen J, Dhoul N, Chan T, Thana L, Kumarapeli P (2006) A study of cardiovascular risk in overweight and obese people in England., Eur J Gen Pract 12 (1) pp. 19-29
OBJECTIVES: To report current levels of obesity and associated cardiac risk using routinely collected primary care computer data. METHODS: 67 practices took part in an educational intervention to improve computer data quality and care in cardiovascular disease. Data were extracted from 435,102 general practice computer records. 64.3% (229,108/362,861) of people age 15 y and older had a body mass index (BMI) recording or a valid height and weight record that enabled BMI to be derived. Data about cardiovascular disease and risk factors were also extracted. The prevalence of disease and the control of risk factors in the overweight and obese population were compared with those of normal body weight. RESULTS: 56.8% of men and 69.3% of women aged over 15 y had a BMI record. 22% of men and 32.3% of women aged 15 to 24 y were overweight or obese; rising each decade to a peak of 65.6% of men and 57.5% of women aged 55 to 64 y. Thereafter, the proportion who were overweight or obese declined. The prevalence of ischaemic heart disease, diabetes mellitus and hypertension rose with increasing levels of obesity; their prevalence in those who are moderately obese was between two and three times that of the general population. Systolic and diastolic blood pressure, blood glucose even in non-diabetics, cholesterol and triglycerides were all elevated in the overweight and obese population. CONCLUSION: Based on the recorded data over half of men and nearly half of women are overweight or obese. They have increased cardiovascular risk, which is not adequately controlled by current practice.
de Lusignan S, Chan T, Wells S, Cooper A, Harvey M, Brew S, Wright M (2003) Can patients with osteoporosis, who should benefit from implementation of the national service framework for older people, be identified from general practice computer records? A pilot study that illustrates the variability of computerized medical records and problems with searching them., Public Health 117 (6) pp. 438-445 Elsevier
Although UK general practice is highly computerized, comprehensive use of these computers is often limited to registration data and the issue of repeat prescriptions. The recording of diagnostic data is patchy. This study examines whether patients with, or at risk of, osteoporosis can be readily identified from general practice computer records. It reports the findings of a pilot study designed to show the variability of recording the diagnosis of osteoporosis and osteopenia, as well as how useful surrogate markers might be to identify these patients. The study also illustrates the difficulties that even skilled practitioners in a primary care research network experience in extracting clinical data from practice information systems. Computer searches were carried out across six practices in a general practice research network in the south-east of England. Two of these practices had previously undertaken research projects in osteoporosis and were consequently expected to have excellent data quality in osteoporosis. These two practices had a combined list size of 27,500 and the remaining practices had a combined practice population of 43,000 patients. The data were found to be variable with over 10-fold differences between practices in the recorded prevalence of osteoporosis diagnosis as well as its surrogate markers-such as fragility fractures, long-term steroid prescription, etc. There was no difference in data quality between the two practices that had conducted osteoporosis research and the rest of the group, other than in the areas of diagnostic recording and prescribing for osteoporosis and recording of fractures. Issues were raised by the practices that struggled to identify patients at risk of osteoporosis about the limitations of Read classification in this disease area. Practices need further assistance if the patients at risk are to be identified. Without urgent action, it will be difficult for practices to identify the patients who are likely to benefit from Standard 6-'Falls' of the National Service Framework for Older People. These findings also have broader implications as UK general practice moves towards the implementation of a quality-based contract.
de Lusignana S, Gallagher H, Jones S, Chan T, van Vlymen J, Tahir A, Thomas N, Jain N, Dmitrieva O, Rafi I, McGovern A, Harris K (2013) Audit-based education lowers systolic blood pressure in chronic kidney disease: the Quality Improvement in CKD (QICKD) trial results., Kidney Int
Strict control of systolic blood pressure is known to slow progression of chronic kidney disease (CKD). Here we compared audit-based education (ABE) to guidelines and prompts or usual practice in lowering systolic blood pressure in people with CKD. This 2-year cluster randomized trial included 93 volunteer general practices randomized into three arms with 30 ABE practices, 32 with guidelines and prompts, and 31 usual practices. An intervention effect on the primary outcome, systolic blood pressure, was calculated using a multilevel model to predict changes after the intervention. The prevalence of CKD was 7.29% (41,183 of 565,016 patients) with all cardiovascular comorbidities more common in those with CKD. Our models showed that the systolic blood pressure was significantly lowered by 2.41 mm Hg (CI 0.59-4.29 mm Hg), in the ABE practices with an odds ratio of achieving at least a 5 mm Hg reduction in systolic blood pressure of 1.24 (CI 1.05-1.45). Practices exposed to guidelines and prompts produced no significant change compared to usual practice. Male gender, ABE, ischemic heart disease, and congestive heart failure were independently associated with a greater lowering of systolic blood pressure but the converse applied to hypertension and age over 75 years. There were no reports of harm. Thus, individuals receiving ABE are more likely to achieve a lower blood pressure than those receiving only usual practice. The findings should be interpreted with caution due to the wide confidence intervals.Kidney International advance online publication, 27 March 2013; doi:10.1038/ki.2013.96.
Crinson I, Gallagher H, Thomas N, de Lusignan S (2010) How ready is general practice to improve quality in chronic kidney disease? A diagnostic analysis., Br J Gen Pract 60 (575) pp. 403-409
Chronic kidney disease (CKD) is associated with increased cardiovascular mortality and morbidity as well as progression to established renal failure. Interventions in primary care, particularly the lowering of blood pressure in individuals with CKD and proteinuria and diabetes, can slow disease progression. This evidence base is codified in national guidance and in a simplified form in pay-for-performance targets. Prior to conducting the QICKD study - a cluster of quality-improvement interventions with reduction of blood pressure as its primary outcome measure - a diagnostic analysis was conducted to assess the relevance of the intended interventions.
De Lusignan S, Wells S, Shaw A, Rowlands G, Crilly T (2005) A knowledge audit of the managers of primary care organizations: top priority is how to use routinely collected clinical data for quality improvement., Med Inform Internet Med 30 (1) pp. 69-80
Technology has provided improved access to the rapidly expanding evidence base and to computerized clinical data recorded as part of routine care. A knowledge audit identifies from within this mass of information the knowledge requirements of a professional group or organization, enabling implementation of an appropriately tailored knowledge-management strategy. The objective of the study is to describe perceived knowledge gaps and recommend an appropriate knowledge-management strategy for primary care. The sample comprised 18 senior managers of Primary Care Trusts: the Chairman, Chief Executive Officer, or Research and Development Lead. A series of interviews were recorded verbatim, transcribed and analysed. Knowledge requirements were broad, suggesting that a broadly based knowledge-management strategy is needed in primary care. The biggest gap in current knowledge identified is how to perform needs assessment and quality improvement using aggregated routinely collected, general practice computer data.
Woodfield R, UK Biobank Stroke Outcomes Group, UK Biobank Follow-up and Outcomes Working Group (2015) Accuracy of Patient Self-Report of Stroke: A Systematic Review from the UK Biobank Stroke Outcomes Group, PloS One 10 (9) pp. 1-14
We performed a systematic review of the accuracy of patient self-report of stroke to inform approaches to ascertaining and confirming stroke cases in large prospective studies.
We sought studies comparing patient self-report against a reference standard for stroke. We extracted data on survey method(s), response rates, participant characteristics, the reference standard used, and the positive predictive value (PPV) of self-report. Where possible
we also calculated sensitivity, specificity, negative predictive value (NPV), and stroke prevalence. Study-level risk of bias was assessed using the Quality Assessment of Diagnostic Studies tool (QUADAS-2).
From >1500 identified articles, we included 17 studies. Most asked patients to report a lifetime history of stroke but a few limited recall time to 5 years. Some included questions for transient ischaemic attack (TIA) or stroke synonyms. No study was free of risk of bias in the
QUADAS-2 assessment, the most frequent causes of bias being incomplete reference standard data, absence of blinding of adjudicators to self-report status, and participant response rates (
(10 studies), specificity from 96?99.6% (10 studies), and NPV from 88.2?99.9% (10 studies). PPV increased with stroke prevalence as expected. Among six studies with available relevant data, if confirmed TIAs were considered to be true rather than false positive strokes, PPV of self-report was >75% in all but one study. It was not possible to assess the
influence of recall time or of the question(s) asked on PPV or sensitivity. Conclusions
Characteristics of the study population strongly influence self-report accuracy. In population based studies with low stroke prevalence, a large proportion of self-reported strokes may be false positives. Self-report is therefore unlikely to be helpful for identifying cases without subsequent confirmation, but may be useful for case ascertainment in combination
with other data sources.
de Lusignan S (2008) Prescribing support software recommends more expensive prescriptions., Inform Prim Care 16 (1) pp. 61-62
Chan T, Cohen A, de Lusignan S (2010) Using routine data to conduct small area health needs assessment through observing trends in demographics, recording of common mental health problems (CMHPs) and sickness certificates: longitudinal analysis of a northern and London locality., Inform Prim Care 18 (4) pp. 273-282
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.
de Lusignan S, Wells S, Singleton A (2002) Why general practitioners do not implement evidence. Learning environments must be created that capitalise on teams' wealth of knowledge., BMJ 324 (7338)
Rafiq M, McGovern A, Jones S, Harris K, Tomson C, Gallagher H, De Lusignan S (2014) Falls in the elderly were predicted opportunistically using a decision tree and systematically using a database-driven screening tool, Journal of Clinical Epidemiology 67 (8) pp. 877-886
Objective 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. Study Design and Setting This multicenter cohort study was part of the quality improvement in chronic kidney disease trial. Routine data for participants aged 65 years and above were collected from 127 general practice (GP) databases across the UK, including sociodemographic, physical, diagnostic, pharmaceutical, lifestyle factors, and records of falls or fractures over 5 years. Multilevel logistic regression analyses were performed to identify predictors. The strongest predictors were used to generate a decision tree and risk score. Results Of the 135,433 individuals included, 10,766 (8%) experienced a fall or fracture during follow-up. Age, female sex, previous fall, nocturia, anti-depressant use, and urinary incontinence were the strongest predictors from our risk profile (area under the receiver operating characteristics curve = 0.72). Medication for hypertension did not increase the falls risk. Females aged over 75 years and subjects with a previous fall were the highest risk groups from the decision tree. The risk profile was converted into a risk score (range -7 to 56). Using a cut-off of e9, sensitivity was 68%, and specificity was 60%. Conclusion Our study developed opportunistic and systematic tools to predict falls without additional mobility assessments.
de Lusignan S, Chan T, Wood O, Hague N, Valentin T, Van Vlymen J (2005) Quality and variability of osteoporosis data in general practice computer records: implications for disease registers., Public Health 119 (9) pp. 771-780
OBJECTIVE: To determine the extent to which routinely collected general practitioner computer data could be used to create disease registers of patients with osteoporosis, and to report any improvement in data quality since previous studies. STUDY DESIGN: Audit using anonymized data extracted from general practice computer records from across England. METHODS: Morbidity Query Information and Export Syntax (MIQUEST) software was used to extract structured data from the 78 volunteer practices that participated in the study. The data were aggregated and analysed. RESULTS: There were 100-fold differences in the rates of recording of relevant data. Many patients receiving treatment had no diagnostic codes. Data about secondary causes of osteoporosis and fractures were more consistently recorded than data relating to falls. There were no data to indicate whether fractures were low impact. T-scores, the gold-standard measure of bone density, were very infrequently recorded. CONCLUSIONS: Sufficient data about secondary causes of osteoporosis exist, and these could be searched to identify patients at risk. Meanwhile, fracture recoding could be improved, including likely fragility fractures, and T-scores could be added to computer records. A systematic approach is needed to raise the computer records to a standard where they can be used as valid and reliable disease registers.
Stone MA, Camosso-Stefinovic J, Wilkinson J, de Lusignan S, Hattersley AT, Khunti K (2010) Incorrect and incomplete coding and classification of diabetes: a systematic review., Diabet Med 27 (5) pp. 491-497
To conduct a systematic review to identify types and implications of incorrect or incomplete coding or classification within diabetes or between diabetes and other conditions; also to determine the availability of evidence regarding frequency of occurrence.
de Lusignan S, Singleton A, Wells S (2004) Lessons from the implementation of a near patient anticoagulant monitoring service in primary care., Inform Prim Care 12 (1) pp. 27-33
OBJECTIVE: To evaluate the implementation of a primary care, nurse-led, near patient anticoagulant monitoring service. DESIGN: Action research workshops, supported by questionnaires and clinical audit, to define the strengths and weaknesses of the service and the effectiveness of the computerised decision support system used to set the dosage of anticoagulant and time interval to the next appointment. SETTING: 13 general practices that implemented anticoagulant monitoring in a primary care organisation in south east England. PARTICIPANTS: 18 practice nurses, 72% of whom had over 20 years' clinical experience; the university-based investigators and managers from the primary care organisation. MAIN OUTCOME MEASURE: The nurses felt that the patients preferred the practice-based service, finding it more personal and accessible. However, circumstances arose where the nurse's intuition had to override the software's advice. The nurses found it stressful when they were unclear whether their decision making represented acceptable variation or dangerous practice. An audit tool was developed to measure the extent to which there was variation from the software's recommendation, and patterns of variation emerged. Most evident was that nurses responded to uncertainty by practising cautiously, shortening the interval until the next visit and slightly reducing the recommended dose of warfarin. CONCLUSIONS: The group, by sharing their experiences through a structured series of workshops, developed an understanding of when it might be appropriate to vary from the decision support software's recommendations and how this could be audited. The technological solution modelled on hospital practice proved hard to implement in primary care.
Chan T, de Lusignan S, Pritchard K (2004) Nurses and IT: a survey of use among community clinical staff., Prof Nurse 19 (8) pp. 449-452
A survey investigated the use of information technology among community nurses and other staff in one primary care trust. Provision of IT was poor across all the staff studied, with health visitors and community nurses lagging slightly behind others. The reasons for the low levels of use need further research so that barriers to using IT can be overcome.
de Lusignan S, Mimnagh C (2006) Breaking the first law of informatics: the Quality and Outcomes Framework (QOF) in the dock., Inform Prim Care 14 (3) pp. 153-156
To report the lessons learned from eight years of feeding back routinely collected cardiovascular data in an educational context
Patients receiving cancer treatment often have one or more co-morbid conditions that are treated pharmacologically. Co-morbidities are recorded in clinical trials usually only at baseline. However, co-morbidities evolve and new ones emerge during cancer treatment. The interaction between multi-morbidity and cancer recovery is significant but poorly understood.
To investigate the effect of co-morbidities (e.g. cardiovascular and diabetes) and medications (e.g. statins, antihypertensives, metformin) on radiotherapy-related toxicity and long-term symptoms in order to identify potential risk factors. The possible protective effect of medications such as statins or antihypertensives in reducing radiotherapy-related toxicity will also be explored.
Two datasets will be linked. 1) CHHiP (Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer) randomised control trial. CHHiP contains pelvic symptoms and radiation-related toxicity reported by patients and clinicians. 2) GP (General Practice) data from RCGP RSC (Royal College of General Practitioners Research and Surveillance Centre). The GP records of CHHiP patients will be extracted, including cardiovascular co-morbidities, diabetes and prescription medications. Statistical analysis of the combined dataset will be performed in order to investigate the effect.
Linking two sources of healthcare data is an exciting area of big healthcare data research. With limited data in clinical trials (not all clinical trials collect information on co-morbidities or medications) and limited lengths of follow-up, linking different sources of information is increasingly needed to investigate long-term outcomes. With increasing pressures to collect detailed information in clinical trials (e.g. co-morbidities, medications), linkage to routinely collected data offers the potential to support efficient conduct of clinical trials.
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.
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.
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).
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.
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.
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.
Tripkovic Laura, Wilson LR, Hart Kathryn, Johnsen Sigurd, de Lusignan Simon, Smith CP, Bucca G, Penson S, Chope G, Elliott Ruan, Hypponen E, Berry J L, Lanham-New Susan (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, American Journal of Clinical Nutrition 106 (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 ¼g/d, was effective in increasing serum total 25(OH)D and to compare their respective efficacy in South Asian and white European women over the winter months within the setting of a large randomized controlled trial.
Design: A randomized, double-blind, placebo-controlled food-fortification trial was conducted in healthy South Asian and white European women aged 20?64 y (n = 335; Surrey, United Kingdom) who consumed placebo, juice supplemented with 15 ¼g vitamin D2, biscuit supplemented with 15 ¼g vitamin D2, juice supplemented with 15 ¼g vitamin D3, or biscuit supplemented with 15 ¼g vitamin D3 daily for 12 wk. Serum 25(OH)D was measured by liquid chromatography?tandem mass spectrometry at baseline and at weeks 6 and 12 of the study.
Results: Postintervention in the 2 ethnic groups combined, both the vitamin D3 biscuit and the vitamin D3 juice groups showed a significantly greater absolute incremental change () in total 25(OH)D when compared with the vitamin D2 biscuit group [ (95% CI): 15.3 nmol/L (7.4, 23.3 nmol/L) (P
Conclusions: With the use of a daily dose of vitamin D relevant to public health recommendations (15 ¼g) and in vehicles relevant to food-fortification strategies, vitamin D3 was more effective than vitamin D2 in increasing serum 25(OH)D in the wintertime. Vitamin D3 may therefore be a preferential form to optimize vitamin D status within the general population. This trial was registered at www.controlled-trials.com as ISRCTN23421591.
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.
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.
Ethnicity recording within primary care computerised medical record (CMR) systems is suboptimal, exacerbated by tangled taxonomies within current coding systems.
To develop a method for extending ethnicity identification using routinely collected data.
We used an ontological method to maximise the reliability and prevalence of ethnicity information in the Royal College of General Practitioner?s Research and Surveillance database. Clinical codes were either directly mapped to ethnicity group or utilised as proxy markers (such as language spoken) from which ethnicity could be inferred. We compared the performance of our method with the recording rates that would be identified by code lists utilised by the UK pay for the performance system, with the help of the Quality and Outcomes Framework (QOF).
Data from 2,059,453 patients across 110 practices were included. The overall categorisable ethnicity using QOF codes was 36.26% (95% confidence interval (CI): 36.20%?36.33%). This rose to 48.57% (CI:48.50%?48.64%) using the described ethnicity mapping process. Mapping increased across all ethnic groups. The largest increase was seen in the white ethnicity category (30.61%; CI: 30.55%?30.67% to 40.24%; CI: 40.17%?40.30%). The highest relative increase was in the ethnic group categorised as the other (0.04%; CI: 0.03%?0.04% to 0.92%; CI: 0.91%?0.93%).
This mapping method substantially increases the prevalence of known ethnicity in CMR data and may aid future epidemiological research based on routine data.
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
de Lusignan S, Dos Santos G, Correa A, Haguinet F, Yonova I, Lair F, Byford R, Ferreira F, Stuttard K, Chan T T (2017) Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England, BMJ Open 78 (5) pp. 1-11
BMJ Publishing Group
To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season?s vaccine.
A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data. This study builds on a feasibility study carried out at the start of the 2015/2016 influenza season. We will report influenza vaccine exposure and any AEIs reported via ADR card or recorded directly into the EHR, from the commencement of influenza vaccination and ends as specified by EMA (30 November 2016).
Ten volunteer English general practices, primarily using the GSK influenza vaccines. They had selected this vaccine in advance of the study.
People who receive a seasonal influenza vaccine, in each age group defined in EMA interim guidance: 6 months to 5 years, 6?12 years, 13?17 years, 18?65 years and >65 years.
The primary outcome measure is the rate of AEIs occurring within 7 days postvaccination, using passive surveillance of general practitioner (GP) EHR systems enhanced by a card-based ADR reporting system. Extracted data will be presented overall by brand (Fluarix Tetra vs others), by age strata and risk groups. The secondary outcome measure is the vaccine uptake among the subjects registered in the enrolled general practices.
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.
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
e15 years without diabetes to those with diabetes, both type 1 and type 2. We developed
logistic regression models to assess the excess risk in diabetes of: conjunctivitis, blepharitis,
stye/chalzion, periorbital cellulitis, keratitis/keratoconjunctivitis, lacrimal gland infection,
endopthalmitis, and ocular antimicrobial prescriptions over a six-year period (2010?2015).
We also analysed the impact of glycaemic control on infection rates in those with diabetes.
All models were adjusted for potential confounders.
Results: We analysed infection risk in 889,856 people without diabetes and 48,584 people with
diabetes (3273 type 1, and 45,311 type 2). After adjustment for confounders both type 1 and
type 2 were associated with increased incidence of conjunctivitis (OR 1.61; 95% CI 1.38?1.88;
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
Conclusions: Conjunctivitis is recorded more frequently in people with diabetes. However, no
substantial increase in recording of other ocular infections was noted. Infection risk was
not found to be associated with the degree of glycaemic control
The Institute of Medicine framework defines six dimensions of quality for healthcare systems: (1) safety, (2) effectiveness, (3) patient centeredness, (4) timeliness of care, (5) efficiency, and (6) equity. Large health datasets provide an opportunity to assess quality in these areas.
To perform an international comparison of the measurability of the delivery of these aims, in people with type 2 diabetes mellitus (T2DM) from large datasets.
We conducted a survey to assess healthcare outcomes data quality of existing databases and disseminated this through professional networks. We examined the data sources used to collect the data, frequency of data uploads, and data types used for identifying people with T2DM. We compared data completeness across the six areas of healthcare quality, using selected measures pertinent to T2DM management.
We received 14 responses from seven countries (Australia, Canada, Italy, the Netherlands, Norway, Portugal, Turkey and the UK). Most databases reported frequent data uploads and would be capable of near real time analysis of healthcare quality.
The majority of recorded data related to safety (particularly medication adverse events) and treatment efficacy (glycaemic control and microvascular disease). Data potentially measuring equity was less well recorded. Recording levels were lowest for patient-centred care, timeliness of care, and system efficiency, with the majority of databases containing no data in these areas. Databases using primary care sources had higher data quality across all areas measured.
Data quality could be improved particularly in the areas of patient-centred care, timeliness, and efficiency. Primary care derived datasets may be most suited to healthcare quality assessment.
Wheeler C, Halter M, Drennan V, de Lusignan S, Grant R, Gabe J, Gage H, Begg P, Ennis J, Parle J (2017) Physician associates working in secondary care teams in England: Interprofessional implications from a national survey, Journal of Interprofessional Care 31 (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.
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.
In September 2015, the United Kingdom became the first country to introduce the multicomponent group B meningococcal vaccine (4CMenB) into a national infant immunisation programme. In early clinical trials 51?61% of infants developed a fever when 4CMenB was administered with other routine vaccines. Whilst administration of prophylactic paracetamol is advised, up to 3% of parents may seek medical advice for fever following vaccination. We used research-level general practitioner consultations to identify any increase in attendances for all-cause fever in vaccine-eligible infants following 4CMenB introduction in England.
Consultations for infant all-cause fever in the year following the vaccine introduction were identified from The Phoenix Partnership (TPP) ResearchOne general practice database using Read (CTV3) codes. Average daily consultation rates and incidence rate ratios (IRRs) were calculated for vaccine-eligible age groups and compared to the two years preceding vaccine introduction. The difference between pre- and post-vaccine all-cause fever consultations was estimated.
All-cause fever consultations in vaccine-eligible 7?10/week olds were 1.6-fold higher (IRR, 1.58; 95% CI, 1.22?2.05) compared to the two previous years and 1.5-fold higher (IRR 1.47; 95% CI, 1.17?1.86) in 15?18/week-olds. There were no significant differences in 0?6 or 11?14/week-olds. Applying the difference between pre- and post-vaccine consultation rates to the 4CMenB vaccine-eligible age groups across England estimated 1825 additional fever consultations in the year following 4CMenB introduction.
We found a small but significant difference in all-cause fever consultation rates in vaccine-eligible infants who would have received 4CMenB with other vaccines.
Longer medication persistence in type 2 diabetes (T2D) is associated with improved glycaemic control. It is not clear which oral therapies have the best persistence.
To compare medication persistence across different oral therapies in people with T2D.
We performed a retrospective cohort analysis using a primary care based population, the Royal College of General Practitioners Research and Surveillance Centre cohort. We identified new prescriptions for oral diabetes medication in people with type 2 diabetes between 1st January 2004 and 31st July 2015. We compared median persistence across each class (non-persistence defined as prescription gap of e 90 days). We also compared non-persistence between classes, adjusting for confounders, using Cox regression. Confounders included: age, gender, ethnicity, socioeconomic status, alcohol use, smoking status, glycaemic control, diabetes duration, diabetes complications, comorbidities, and number of previous and concurrent diabetes medications.
We identified 60,327 adults with T2D. The majority 42,810 (70.9%) of people had one or more oral medications prescribed. In these patients we measured persistence with 55,728 oral medications. Metformin had the longest median persistence (3.04 years; 95% CI 2.94 to 3.12). The adjusted hazard ratios for non-persistence compared with metformin were: sulfonylureas HR 1.20 (1.16 to 1.24), DPP-4 inhibitors HR 1.43 (1.38 to 1.49), thiazolidinediones HR 1.71 (95% CI 1.64-1.77), SGLT2 inhibitors HR 1.04 (0.93 to 1.17), meglitinides HR 2.25 (1.97 to 2.58), and alpha-glucosidase inhibitors HR 2.45 (1.98 to 3.02). The analysis of SGLT2 inhibitors was limited by the short duration of follow-up for this new class. Other factors associated with reduced medication persistence are female gender, younger age, and non-white ethnicity.
Persistence is strongly influenced by medication class and should be considered when initiating treatments.
Williams R, Alexander G, Armstrong I, Baker A, Bhala N, Camps-Walsh G, Cramp M, de Lusignan S, Day N, Dhawan A, Dillon J, Drummond C, Dyson J, Foster G, Gilmore I, Hudson M, Kelly D, Langford A, McDougall N, Meier P, Moriarty K, Newsome P, O?Grady J, Pryke R, Rolfe L, Rice P, Rutter H, Sheron N, Taylor A, Thompson J, Thorburn D, Verne J, Wass J, Yeoman A (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, The Lancet 391 (10125) pp. 1097-1107
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.
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.
Physician associates are new to English general practice and set to expand
To investigate the patients? perspective on consulting with physician
associates in general practice.
A qualitative study, using semi-structured interviews, with thematic analysis.
Setting and participants:
Thirty volunteer patients of 430 who had consulted physician
associates for a same-day appointment and had returned a satisfaction survey, in six
general practices employing physician associates in England.
Some participants only consulted once with a physician associate and others
more frequently. The conditions consulted for ranged from minor illnesses to those
requiring immediate hospital admission. Understanding the role of the physician associate
varied from ?certain and correct? to ?uncertain?, to ?certain and incorrect?, where
the patient believed the physician associate to be a doctor. Most, but not all, reported
positive experiences and outcomes of their consultation, with some choosing to consult
the physician. Those with negative experiences described problems when the limits
of the role were reached, requiring additional GP consultations or prescription
delay. Trust and confidence in the physician associate was derived from trust in the
NHS, the general practice and the individual physician associate. Willingness to consult
a physician associate was contingent on the patient?s assessment of the severity
or complexity of the problem and the desire for provider continuity.
Patients saw physician associates as an appropriate general practitioner
substitute. Patients? experience could inform delivery redesign.
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 e70 y, without a known diagnosis of dementia, living in their own homes. There were 6,387 such patients in 11 intervention practices and 8,171 in the control practices. The primary outcome was cognitive severity on Mini Mental State Examination (MMSE). Main secondary outcomes were proportion of patients consulting their GP with suspected memory disorders and proportion of those referred to memory clinics. There was no between-group difference in cognitive severity at diagnosis (99 intervention, mean MMSE = 22.04, 95% confidence intervals (CIs) = 20.95 to 23.13; 124 control, mean MMSE = 22.59, 95% CI = 21.58 to 23.6; p = 0.48). GP consultations with patients with suspected memory disorders increased in intervention versus control group (odds ratio = 1.41; 95% CI = 1.28, 1.54). There was no between-group difference in the proportions of patients referred to memory clinics (166, 2.5%; 220, 2.7%; p = .077 respectively). The study was limited as we do not know whether the additional patients presenting to GPs had objective as well as subjective memory problems and therefore should have been referred. In addition, we aimed to empower patients but did not do anything to change GP practice.
Our intervention to access timely dementia diagnosis resulted in more patients presenting to GPs with memory problems, but no diagnoses increase. We are uncertain as to the reason for this and do not know whether empowering the public and targeting GPs would have resulted in a successful intervention. Future interventions should be targeted at both patients and GPs.
Haux R, Kulikowski C, Bakken S, de Lusignan S, Kimura M, Koch S, Mantas J, Maojo V, Marschollek M, Martin-Sanchez F, Moen A, Park H, Sarkar I, Leong T, McCray A (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, Methods of Information in Medicine 56 pp. e1-e10
Wiley Open Access
Medical informatics, or biomedical and health informatics (BMHI), has become an established scientific discipline. In all such disciplines there is a certain inertia to persist in focusing on well-established research areas and to hold on to well-known research methodologies rather than adopting new ones, which may be more appropriate.
To search for answers to the following questions: What are research fields in informatics, which are not being currently adequately addressed, and which methodological approaches might be insufficiently used? Do we know about reasons? What could be consequences of change for research and for education?
Outstanding informatics scientists were invited to three panel sessions on this topic in leading international conferences (MIE 2015, Medinfo 2015, HEC 2016) in order to get their answers to these questions.
A variety of themes emerged in the set of answers provided by the panellists. Some panellists took the theoretical foundations of the field for granted, while several questioned whether the field was actually grounded in a strong theoretical foundation. Panellists proposed a range of suggestions for new or improved approaches, methodologies, and techniques to enhance the BMHI research agenda.
The field of BMHI is on the one hand maturing as an academic community and intellectual endeavour. On the other hand vendor-supplied solutions may be too readily and uncritically accepted in health care practice. There is a high chance that BMHI will continue to flourish as an important discipline; its innovative interventions might then reach the original objectives of advancing science and improving health care outcomes.
Hine J, de Lusignan S, Burleigh D, Pathirannehelage S, McGovern A, Gatenby P, Jones S, Jiang D, Williams J, Elliot A, Smith G, Brownrigg J, Hinchliffe R, Munro N (2016) Association between glycaemic control and common infections in people with Type 2 diabetes: a cohort study, Diabetic Medicine 34 (4) pp. 551-557
To investigate the impact of glycaemic control on infection incidence in people with Type 2 diabetes.
We compared infection rates during 2014 in people with Type 2 diabetes and people without diabetes in a large primary care cohort in the UK (the Royal College of General Practitioners Research and Surveillance Centre database). We performed multilevel logistic regression to investigate the impact of Type 2 diabetes on presentation with infection, and the effect of glycaemic control on presentation with upper respiratory tract infections, bronchitis, influenza-like illness, pneumonia, intestinal infectious diseases, herpes simplex, skin and soft tissue infections, urinary tract infections, and genital and perineal infections. People with Type 2 diabetes were stratified by good [HbA1c 69 mmol/mol (> 8.5%)] glycaemic control using their most recent HbA1c concentration. Infection incidence was adjusted for important sociodemographic factors and patient comorbidities.
We identified 34 278 people with Type 2 diabetes and 613 052 people without diabetes for comparison. The incidence of infections was higher in people with Type 2 diabetes for all infections except herpes simplex. Worsening glycaemic control was associated with increased incidence of bronchitis, pneumonia, skin and soft tissue infections, urinary tract infections, and genital and perineal infections, but not with upper respiratory tract infections, influenza-like illness, intestinal infectious diseases or herpes simplex.
Almost all infections analysed were more common in people with Type 2 diabetes. Infections that are most commonly of bacterial, fungal or yeast origin were more frequent in people with worse glycaemic control.
Wahl S, Drong A, Lehne B, Loh M, Scott W, Kunze S, Tsai P, Ried J, Zhang W, Yang Y, Tan S, Fiorito G, Franke L, Guarrera S, Kasela S, Kriebel J, Richmond R, Adamo M, Afzal U, Ala-Korpela M, Albetti B, Ammerpohl O, Apperley J, Beekman M, Bertazzi P, Black S, Blancher C, Bonder M, Brosch M, Carstensen-Kirberg M, de Craen A, de Lusignan S, Dehghan A, Elkalaawy M, Fischer K, Franco O, Gaunt T, Hampe J, Hashemi M, Isaacs A, Jenkinson A, Jha S, Kato N, Krogh V, Laffan M, Meisinger C, Meitinger T, Mok Z, Motta V, Ng H, Nikolakopoulou Z, Nteliopoulos G, Panico S, Pervjakova N, Prokisch H, Rathmann W, Roden M, Rota F, Rozario M, Sandling J, Schafmayer C, Schramm K, Siebert R, Slagboom P, Soininen P, Stolk L, Strauch K, Tai E, Tarantini L, Thorand B, Tigchelaar E, Tumino R, Uitterlinden A, van Duijn C, van Meurs J, Vineis P, Wickremasinghe A, Wijmenga C, Yang T, Yuan W, Zhernakova A, Batterham R, Smith G, Deloukas P, Heijmans B, Herder C, Hofman A, Lindgren C, Milani L, van der Harst P, Peters A, Illig T, Relton C, Waldenberger M, Järvelin M, Bollati V, Soong R, Spector T, Scott J, McCarthy M, Elliott P, Bell J, Matullo G, Gieger C, Kooner J, Grallert H, Chambers J (2016) Epigenome-wide association study of body mass index, and the adverse outcomes of adiposity, Nature 541 (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
Allergic rhinitis (AR) is a global health problem, potentially impacting individuals? sleep, work and social life. We aimed to use a surveillance network of general practitioners (GPs) to describe the epidemiology of AR consultations in England.
A large GP surveillance network covering approximately 53% of the English population.
GP consultations for AR across England between 30 December 2002 and 31 December 2014 were analysed. Using more granular data available between 2 April 2012 and 31 December 2014 rates and rate ratios (RR) of AR were further analysed in different age groups, gender, rural-urban classification and index of multiple deprivation score quintile of location of GP.
The mean weekly rate for AR consultations was 19.8 consultations per 100 000 GP registered patients (range 1.13?207), with a regular peak occurring during June (weeks 24?26), and a smaller peak during April. Between 1 April 2012 and 31 December 2014, the highest mean daily rates of consultations per 1 00 000 were: in age group 5?14 years (rate=8.02, RR 6.65, 95% CI 6.38 to 6.93); females (rate=4.57, RR 1.12 95% CI 1.12 to 1.13); persons registered at a GP in the most socioeconomically deprived quintile local authority (rate=5.69, RR 1.48, 95% CI 1.47 to 1.49) or in an urban area with major conurbation (rate=5.91, RR 1.78, 95% CI 1.69 to 1.87).
AR rates were higher in those aged 5?14 years, females and in urban and socioeconomically deprived areas. This needs to be viewed in the context of this study?s limitations but should be considered in health promotion and service planning.
There are limited case-mix classification systems for primary care settings which are applicable when considering the optimal clinical skill mix to provide services.
To develop a case-mix classification system (CMCS) and test its impact on analyses of patient outcomes by clinician type, using example data from physician associates? (PAs) and GPs' consultations with same-day appointment patients.
Design & setting
Secondary analysis of controlled observational data from six general practices employing PAs and six matched practices not employing PAs in England.
Routinely-collected patient consultation records (PA n = 932, GP n = 1154) were used to design the CMCS (combining problem codes, disease register data, and free text); to describe the case-mix; and to assess impact of statistical adjustment for the CMCS on comparison of outcomes of consultations with PAs and with GPs.
A CMCS was developed by extending a system that only classified 18.6% (213/1147) of the presenting problems in this study's data. The CMCS differentiated the presenting patient?s level of need or complexity as: acute, chronic, minor problem or symptom, prevention, or process of care, applied hierarchically. Combination of patient and consultation-level measures resulted in a higher classification of acuity and complexity for 639 (30.6%) of patient cases in this sample than if using consultation level alone. The CMCS was a key adjustment in modelling the study?s main outcome measure, that is rate of repeat consultation.
This CMCS assisted in classifying the differences in case-mix between professions, thereby allowing fairer assessment of the potential for role substitution and task shifting in primary care, but it requires further validation.
Woodmansey C, Mcgovern A, McCullough K, Whyte M, Munro N, Correa A, Gatenby P, Jones S, de Lusignan S (2017) Incidence, Demographics, and Clinical Characteristics of Diabetes of the Exocrine Pancreas (Type 3c): A Retrospective Cohort Study, Diabetes Care 40 (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 e7% [53 mmol/mol]) and insulin requirement.
RESULTS: We identified 31,789 new diagnoses of adult-onset diabetes. Diabetes following pancreatic disease (2.59 [95% CI 2.38?2.81] per 100,000 person-years) was more common than type 1 diabetes (1.64 [1.47?1.82]; P
CONCLUSIONS: Diabetes of the exocrine pancreas is frequently labeled type 2 diabetes but has worse glycemic control and a markedly greater requirement for insulin.
Kumar S, de Lusignan S, Mcgovern A, Correa A, Hriskova M, Gatenby P, Jones S, Goldsmith D, Camm J (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, BMJ 360 k342 pp. 1-10
BMJ Publishing Group
To assess the association between anticoagulation, ischaemic stroke, gastrointestinal and cerebral haemorrhage, and all cause mortality in older people with atrial fibrillation and chronic kidney disease.
Propensity matched, population based, retrospective cohort analysis from January 2006 through December 2016.
The Royal College of General Practitioners Research and Surveillance Centre database population of almost 2.73 million patients from 110 general practices across England and Wales.
Patients aged 65 years and over with a new diagnosis of atrial fibrillation and estimated glomerular filtration rate (eGFR) of
Receipt of an anticoagulant prescription within 60 days of atrial fibrillation diagnosis.
Main outcome measures
Ischaemic stroke, cerebral or gastrointestinal haemorrhage, and all cause mortality.
6977 patients with chronic kidney disease and newly diagnosed atrial fibrillation were identified, of whom 2434 were on anticoagulants within 60 days of diagnosis and 4543 were not. 2434 pairs were matched using propensity scores by exposure to anticoagulant or none and followed for a median of 506 days. The crude rates for ischaemic stroke and haemorrhage were 4.6 and 1.2 after taking anticoagulants and 1.5 and 0.4 in patients who were not taking anticoagulant per 100 person years, respectively. The hazard ratios for ischaemic stroke, haemorrhage, and all cause mortality for those on anticoagulants were 2.60 (95% confidence interval 2.00 to 3.38), 2.42 (1.44 to 4.05), and 0.82 (0.74 to 0.91) compared with those who received no anticoagulation.
Giving anticoagulants to older people with concomitant atrial fibrillation and chronic kidney disease was associated with an increased rate of ischaemic stroke and haemorrhage but a paradoxical lowered rate of all cause mortality. Careful consideration should be given before starting anticoagulants in older people with chronic kidney disease who develop atrial fibrillation. There remains an urgent need for adequately powered randomised trials in this population to explore these findings and to provide clarity on correct clinical management.
Medication non-adherence and non-persistence in type 2 diabetes (T2D) are common and associated with poor outcomes. Medication attributes have a major influence on adherence in chronic disease but it is not clear which medication classes are associated with better adherence and persistence in T2D.
A systematic review and cohort analyses of comparative adherence and persistence across medication classes in T2D was performed. MEDLINE, Embase, The Cochrane Library, The Cochrane Register of Controlled Trials, PsycINFO, and CINAHL were searched for studies comparing class adherence and persistence. Where n>5 studies provided the same comparison a meta-analysis was performed. Retrospective cohort analyses used the Royal College of General Practitioners Research and Surveillance database to compare adherence and persistence with oral medications.
The systematic review synthesised 66 studies (38 in meta-analyses). Adherence was better with thiazolidinediones (TZDs) and sulphonylureas than metformin. TZDs had slightly better adherence than sulphonylureas. Limited data suggest low adherence with alpha-glucosidase inhibitors (AGIs) and meglitinides. Insulin analogues had longer persistence than GLP1 analogues and human insulins. There was little data on comparative persistence with oral medications and adherence with injectable medications. Adherence and persistence were measured in cohorts of 60,327 and 145,546 people with T2D respectively (55,728 and 76,593 oral medications). After adjustment in regression models metformin and SGLT2 inhibitors had the longest persistence, AGIs and meglitinides the shortest. TZDs, DPP4 inhibitors, and SGLT2 inhibitors had the highest adherence, and metformin, AGIs and meglitinides the lowest. Sulphonylureas had intermediate adherence and persistence. Younger age, female gender, and non-white ethnicity were also associated with reduced persistence and adherence.
Adherence and persistence vary considerable between classes of medication for T2D. Class switching may improve adherence in people with low adherence e.g. metformin to DPP4 inhibitors. Pre-emptive selection of classes which promote adherence in those with non-adherence risk factors may also improve outcomes.
Guthrie E, Afzal C, Blakeley C, Blakemore A, Byford R, Camacho E, Chan T, Chew-Graham C, Davies L, de Lusignan S, Dickens C, Drinkwater J, Dunn G, Hunter C, Joy M, Kapur N, Langer S, Lovell K, Macklin J, Mackway-Jones K, Ntais D, Salmon P, Tomenson B, Watson J (2017) CHOICE: Choosing Health Options In Chronic Care Emergencies, Programme Grants for Applied Research 5 (13) pp. 1-271
Over 70% of the health-care budget in England is spent on the care of people with long-term
conditions (LTCs), and a major cost component is unscheduled health care. Psychological morbidity is high in
people with LTCs and is associated with a range of adverse outcomes, including increased mortality, poorer
physical health outcomes, increased health costs and service utilisation.
The aim of this programme of research was to examine the relationship between
psychological morbidity and use of unscheduled care in people with LTCs, and to develop a psychosocial
intervention that would have the potential to reduce unscheduled care use. We focused largely on
emergency hospital admissions (EHAs) and attendances at emergency departments (EDs).
A three-phase mixed-methods study. Research methods included systematic reviews; a
longitudinal prospective cohort study in primary care to identify people with LTCs at risk of EHA or ED
admission; a replication study in primary care using routinely collected data; an exploratory and feasibility
cluster randomised controlled trial in primary care; and qualitative studies to identify personal reasons
for the use of unscheduled care and factors in routine consultations in primary care that may influence
health-care use. People with lived experience of LTCs worked closely with the research team.
Setting: Primary care. Manchester and London.
Participants: People aged e 18 years with at least one of four common LTCs: asthma, coronary
heart disease, chronic obstructive pulmonary disease (COPD) and diabetes. Participants also included
Evidence synthesis suggested that depression, but not anxiety, is a predictor of use of unscheduled
care in patients with LTCs, and low-intensity complex interventions reduce unscheduled care use in people
with asthma and COPD. The results of the prospective study were that depression, not having a partner
and life stressors, in addition to prior use of unscheduled care, severity of illness and multimorbidity, were
independent predictors of EHA and ED admission. Approximately half of the cost of health care for people
with LTCs was accounted for by use of unscheduled care. The results of the replication study, carried out in
London, broadly supported our findings for risk of ED attendances, but not EHAs. This was most likely due to
low rates of detection of depression in general practitioner (GP) data sets. Qualitative work showed that
patients were reluctant to use unscheduled care, deciding to do so when they perceived a serious and urgent
need for care, and following previous experience that unscheduled care had successfully and unquestioningly
met similar needs in the past. In general, emergency and primary care doctors did not regard unscheduled
care as problematic. We found there are missed opportunities to identify and discuss psychosocial issues
during routine consultations in primary care due to the ?overmechanisation? of routine health-care reviews.
The feasibility trial examined two levels of an intervention for people with COPD: we tried to improve the
way in which practices manage patients with COPD and developed a targeted psychosocial treatment for
patients at risk of using unscheduled care. The former had low acceptability, whereas the latter had high
acceptability. Exploratory health economic analyses suggested that the practice-level intervention would be
unlikely to be cost-effective, limiting the value of detailed health economic modelling.
The findings of this programme may not apply to all people with LTCs. It was conducted in
an area of high social deprivation, which may limit the generalisability to more affluent areas. The response
rate to the prospective longitudinal study was low. The feasibility trial focused solely on people with COPD.
Conclusions: Prior use of unscheduled care is the most powerful predictor of unscheduled care use in
To characterize the risk uveitis, scleritis or episcleritis in relation to diabetes, glycaemic control, and co-existence of retinopathy.
Using the Royal College of General Practitioners Research and Surveillance Centre database, we established the prevalence of acute uveitis and scleritis or episcleritis over a six-year period among populations without(n/=/889,856) and with diabetes(n/=/48,584). We evaluated the impact of glycaemic control on disease risk. Regression modeling was used to identify associations, adjusting for clinical and demographic confounders.
Incidence of acute uveitis was higher among patients with diabetes; Type 1 OR:2.01 (95% CI 1.18?3.41; p/=/0.009), and Type 2 OR:1.23 (1.05?1.44; p/=/0.01). Glycaemic control was established as an important effect modifier for uveitis risk, whereby those with poorer control suffered higher disease burden. Results confirmed a dose-response relationship such that very poor glycaemic control OR:4.72 (2.58?8.65; p/0.001), poor control OR:1.57 (1.05?2.33; p/=/0.03) and moderate control OR:1.20 (0.86?1.68; p/=/0.29) were predictive of uveitis. Similar results were observed when evaluating retinopathy staging: proliferative retinopathy OR:2.42 (1.25?4.69; p/=/0.01). These results were not maintained for scleritis or episcleritis.
Acute uveitis is more common in patients with diabetes; at highest risk are those with type 1 disease with poor glycaemic control. Glycaemic improvements may prevent recurrence.
The purpose of this study was to explore the managing of Type 2 Diabetes Mellitus (T2DM) in the Saudi healthcare system. This country was chosen for examination because it has been undergoing major demographic, social and economic changes which have caused an increase in the prevalence of chronic diseases, including diabetes. This study adopted the World Health Organization's (WHO) Innovative Care for Chronic Conditions Framework (ICCCF). This framework provided a comprehensive basis for assessing the Saudi healthcare system by addressing its components at the macro (policy), meso (healthcare organizations and community), and micro (patient and family) levels. In accordance with these three health system strata, a flexible multimethod approach was adopted by using primary and secondary data in three phases. To explore the policy environment of the Saudi health care system, the first phase involved analysing 35 national and regional T2DM documents according to four dimensions of Walt and Gilson?s health policy analysis framework: content, actors, context, and process. The second phase aimed to explore healthcare professionals? perceptions of the barriers and facilitators of an effective healthcare organization and of community partnerships to enable T2DM management. Semi-structured interviews were conducted with 33 participants from various healthcare fields and thematic analyses were applied. The third phase aimed to assess the patients? experiences and their interactions with healthcare providers. In this phase, the Patient Assessment of Chronic Illness Care (PACIC) survey was translated into Arabic using the WHO Steps of Translation and Adaptation of Instruments, and distributed among 575 diabetes patients in four specialized diabetes clinics. Although T2DM has highly recognised at the macro level, several challenges were identified through the documents analysis and were also highlighted during the second phase of the study. These challenges included: unreliable health information systems, a lack of multisectoral collaboration, and a lack of public awareness. At the meso level, the interview data identified three themes: the cultural determinants of T2DM, the limitations of key support systems, and recommendations for improving the support systems for T2DM patients. Within the identified themes, a number of subthemes were identified, including: physical inactivity, reliance on traditional treatments, unhealthy dietary patterns, poor primary healthcare services, lack of reliable data, shortage of qualified staff, poor guidelines dissemination, enhancing the multisectorial collaboration, and community partnerships. At the micro level, the mean score of the PACIC survey was lower in comparison to similar studies conducted internationally (mean = 2.55 out of 5). Patients scored on average 2.69 for ?patient activation?, 3.02 for ?delivery system/practice design?, 2.29 for ?goal setting/tailoring?, 2.10 for ?follow-up/coordination?, and 2.84 for ?problem solving/contextual domain?. In addition, the reported glycaemic control measures indicated that only 17% of participants had controlled blood glucose levels (d 7%) which is equivalent to 8.6 mmol/L. The ICCC framework was a useful tool for exploring the main weaknesses and strengths of the Saudi healthcare system. However, it was observed that the ICCC did not significantly recognize community sensitivity, particularly community culture, religion, norms, and beliefs. Nevertheless, this study generated new knowledge about T2DM management systems in Saudi Arabia by exploring how the performance of the healthcare system is shaped by the processes occurring at the different levels; therefore. It contributes to the body of knowledge on health system research.
Halter Mary, Wheeler Carly, Pelone Ferruccio, Gage Heather, de Lusignan Simon, Parle Jim, Grant Robert, Gabe Jonathan, Nice Laura, Drennan Vari M (2018) Contribution of physician assistants/associates to secondary care: a systematic review, BMJ Open 8 (6) e019573 pp. e019573-1
BMJ Publishing Group
To appraise and synthesise research on the impact of physician assistants/associates (PA) in secondary care, specifically acute internal medicine, care of the elderly, emergency medicine, trauma and orthopaedics, and mental health.
Electronic databases (Medline, Embase, ASSIA, CINAHL, SCOPUS, PsycINFO, Social Policy and Practice, EconLit and Cochrane), reference lists and related articles.
Peer-reviewed articles of any study design, published in English, 1995?2017.
Blinded parallel processes were used to screen abstracts and full text, data extractions and quality assessments against published guidelines. A narrative synthesis was undertaken.
Impact on: patients? experiences and outcomes, service organisation, working practices, other professional groups and costs.
5472 references were identified and 161 read in full; 16 were included?emergency medicine (7), trauma and orthopaedics (6), acute internal medicine (2), mental health (1) and care of the elderly (0). All studies were observational, with variable methodological quality. In emergency medicine and in trauma and orthopaedics, when PAs are added to teams, reduced waiting and process times, lower charges, equivalent readmission rate and good acceptability to staff and patients are reported. Analgesia prescribing, operative complications and mortality outcomes were variable. In internal medicine outcomes of care provided by PAs and doctors were equivalent.
PAs have been deployed to increase the capacity of a team, enabling gains in waiting time, throughput, continuity and medical cover. When PAs were compared with medical staff, reassuringly there was little or no negative effect on health outcomes or cost. The difficulty of attributing cause and effect in complex systems where work is organised in teams is highlighted. Further rigorous evaluation is required to address the complexity of the PA role, reporting on more than one setting, and including comparison between PAs and roles for which they are substituting.
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.
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.
The 'connected world' forces us to think about 'interoperability' as a primary requirement when building health care databases in the present day. Whilst semantic interoperability has made a major contribution to data utilisation between systems it often has not been able to integrate some large heterogeneous datasets required for research. As health data gets 'bigger' and complex, we are required to shift to rapid and flexible ways of resolving problems related to semantic interoperability. Ontological approaches accelerate implementing interoperability due to the availability of robust tools and technology frameworks that promote reuse.
This thesis reports the results of a mixed methods study that proposes a pragmatic methodology that maximises the use of ontologies across a multilayered research readiness model which can be used in data-driven health care research projects. The research examined evidence for the use of ontologies across a majority of layers in the reference model. The first part of the thesis examines the methods used for assessing readiness to participate in research across six dimensions of health care. It reports on existing ontological elements that boosts research readiness and also proposes ontological extensions for modelling the semantics of data sources and research study requirements. The second part of the thesis presents an ontology toolkit that supports rapid development of ontologies that can be used in health care research projects. It provides details of how an ontology toolkit for creating health care ontologies was developed through the consensus of a panel of informatics experts and clinicians. This toolkit evolved further to include a series of ontological building blocks that assist clinicians to rapidly build ontologies.
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
de Lusignan Simon, McGee Christopher, Webb Rebecca, Joy Mark, Byford Rachel, Yonova Ivelina, Hriskova Mariya, Ferreira Filipa, Elliot Alex J, Smith Gillian, Rafi Imran (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, JMIR Public Health and Surveillance 4 (4) e11354
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<.001 for="" conurbation="" compared="" with="" rural="" dwellers.="" living="" was="" associated="" a="" lower="" or="" both="" asthma="" ci="" p="" and="" respiratory="" tract="" infections="" dwellers="" the="" upper="" infection="" greater="" in="" urban="" but="" no="" different="" acute="" gastroenteritis="" followed="" same="" pattern:="" urinary="" higher="">
Conclusions: Those living in conurbations or urban areas were more likely to consult a general practice for allergic rhinitis and upper respiratory tract infection. Both conurbation and rural living were associated with an increased risk of urinary tract infection. Living in rural areas was associated with an increased risk of asthma and lower respiratory tract infections. The data suggest that living environment may affect rates of consultations for certain conditions. Longitudinal analyses of these data would be useful in providing insights into important determinants.
The aim of this PhD study was to gain greater understanding of staff experience of being well led within a NHS Hospital Trust rated ?well led? by the Care Quality Commission (CQC), to better understand the potential contribution leaders could make to improve quality of patient care.
A qualitative case study method was utilised to explore staff experiences in the ?well led? Trust. A theoretical framework was developed to underpin the methodological process, incorporating components of learning organisational theory (Argyris 1995 & Senge 1990) and an interpretive grounded theory approach was applied (Charmaz 2006).
Four main themes were identified:
" A sense of ?family?, particularly a focus on shared values and behaviours that prioritised both patient and staff wellbeing.
" A strong preference for a distributed leadership model that was balanced against a need for a hierarchical model.
" A learning approach was balanced against a robust commitment to sanction behaviours outside the values of the organisation.
" A clear ambition to build resilience and embed these values to sustain the ?well led? approach in the face of significant financial pressures and work force challenges.
Many of the principles of learning organisation theory, identified by Argyris (1992) & Senge (1990), were visible across all four themes.
However, there were also some important differences. In particular, there were challenges related to the organisational requirement to balance strategies to both promote staff commitment, as well as compliance. Furthermore, there were similar challenges linking parallel, but disparate models of distributed and hierarchical leadership.
The findings identified both the features of a well led NHS Trust and also some challenges. These new insights contribute to our current understanding of ?well led? Trusts, which can be used to improve Trust level leadership more broadly in the NHS, and also provide a framework for further research in this area.
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 Â0.001) 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.
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.
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.
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.
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.
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.
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 e 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 e 35 and 6.46% (95% CI 6.46-6.40-6.56) in ex or current smokers.
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.
Drennan Vari M, Halter Mary, Wheeler Carly, Nice Laura, Brearley Sally, Ennis James, Gabe Jonathan, Gage Heather, Levenson Ros, de Lusignan Simon, Begg Phil, Parle James (2019) What is the contribution of physician associates in hospital care in England? A mixed methods, multiple case study, BMJ Open 9 (1) e027012 pp. 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.
Context: The UK Nepali community is a unique migrant population, with recent expansion and presence in the UK following the approval of settlement rights to Gurkha veterans and their dependents granted from 2004 to 2008. The community is heterogeneous in relation to caste and religion, with Ghurkha military ties the principal denominator to bind this newly arrived population. Many in the community have settled close to military institutions, with a new migrant population that has emerged as a result around the Aldershot area in Hampshire and Surrey.
The health awareness and needs of the UK Nepali community is poorly understood, including in chronic viral hepatitis (CVH), with increased hepatitis B and C (HBV and HCV) risks that are well described in migrant groups from the neighbouring countries of India and China, but with no previous studies in the UK Nepali population.
HBV and HCV is a global disease, and carries a higher death toll than that seen in comparison to HIV or tuberculosis. CVH disproportionately affects some migrant groups, with case-finding to test at-risk groups part of national guidance by the National Institute of Health and Care Excellence (NICE), as well as the World Health Organisation (WHO), with WHO goals that look to eradicate HBV and HCV by 2030.
At the same time, migrant groups such as the recently arrived Nepali community face growing political and social pressures, with rising nationalism and anti-migrant sentiment seen across Europe, and with blood borne virus rates that have been specifically targeted by right-wing political groups in the UK.
CVH is typically asymptomatic until advanced and severe complications develop; but with highly effective and well-tolerated treatments available if disease is identified at the right time. Effective case-finding to identify CVH in at-risk groups is therefore a priority, and a key aim of national (NICE) CVH testing guidance. The awareness and implementation of this policy is however largely unknown, with particular deficits in our understanding of testing activity in primary care, which remains crucial to delivering CVH testing in migrant communities nationally.
The following study therefore presents a comprehensive exploration of the potential barriers and facilitators that exist towards CVH testing in migrant groups, taking the Nepali community as the focus of this thesis. It explores the factors that exist at the policy level towards effective testing delivery in migrant groups, and at the local (community) level towards CVH testing in primary care, and compares the understanding and perception of the newly arrived Nepali community towards liver disease, and the development of a community based study to identify the CVH risks in the local Nepali population.
Intervention: At the macro-level a policy prioritisation framework was utilised to look at the factors that influence how CVH testing policy can achieve political attention and resources for its implementation. At the community (micro) level, focus group studies were undertaken with members of the Nepali population to explore the awareness, knowledge and perception of liver disease, as well as the potential risks and barriers that may exist towards health engagement strategies. Qualitative focus studies were also conducted with General Practitioners (GPs) from 3 local GP practices who serve the recently arrived Nepali community, to understand the awareness, knowledge and perception of CVH testing in migrant groups. A dedicated community-based testing intervention was then developed to directly assess HBV and HCV prevalence in the local Nepali community, building on the findings from local focus group studies.
Outcome: At the policy level, the National Institute for Health and Care Excellence has produced CVH testing recommendations that are far-reaching, and would have a positive impact on CVH testing in migrant communities, including the UK Nepali population. However, policy has been
Despite therapeutic and interventional technological advances, the global burden of cardiovascular disease is increasing. Accumulated deoxyribonucleic acid (DNA) damage and subsequent repair pathways are now increasingly recognised as a causal factor in the initiation and progression of atherosclerosis. These molecular alterations have been shown to occur within affected vasculature, plaque microenvironment as well as in circulating cells. The DNA damage response (DDR) pathway is reliant on post-translational modification of sensing proteins which activate a signalling cascade to repair, if possible, DNA damaged sites in response to various environmental and physiological insults.
Most studies to-date have focussed on animal models and cells cultured directly from atherosclerotic plaque to ascertain if altered DDR and DNA repair exist and indeed contribute to the atherosclerotic process. By using peripheral whole blood as the base for down-stream analyses, an accessible method of determining if altered expression of genes involved in DDR and enzymes involved in DNA repair could be exploited.
DNA ligase is crucial in single (ssDNA) and double-stranded DNA break repair (DSBR) by facilitating the joining of DNA strands by catalysing phosphodiester bond formation. It was therefore chosen as a marker of DNA repair being a key enzyme involved in base excision repair (BER) and DSBR.
This study examined the differential expression of 22 genes pertinent in the DNA damage and response pathway (DDR), in addition to DNA ligase activity, between patients with stable, unstable coronary atherosclerosis (both undergoing percutaneous coronary intervention for obstructive coronary disease) and healthy controls. In addition, correlations were performed between atherosclerotic plaque features and both DNA ligase activity and the genes of interest. To accurately analyse plaque morphology, frequency domain optical coherence tomography (FD-OCT) was used which allowed high resolution delineation of fibrous tissue, lipid accumulation, calcific deposition and fibrous cap thickness, all key features in plaque vulnerability and therefore of clinical significance.
Peripheral blood mononuclear cells (PBMC) were isolated and DNA repair activity was measured from derived nuclear extracts, using a novel microplate assay examining mean
apparent DNA ligase activity. A custom microarray for the 22 genes of interest was used to perform quantitative reverse transcription polymerase chain reaction for differential gene expression between all 3 cohorts of patients recruited.
Data from this study demonstrated differences in DNA ligase activity and expression of genes involved in the DDR in patients with coronary atherosclerosis. DNA ligase activity correlated with the arc of lipid and cap thickness in both stable and unstable coronary patients. Differential DDR gene expression also correlated with fibrous cap thickness, predominantly in the unstable coronary group. This suggests that such alterations may contribute to the development and progression of the atherosclerotic lipid rich necrotic core as well as protective fibrous cap thickness.
Although significant correlations were found between DNA ligase, genes of interest and plaque features, this study demonstrates an association but does not provide a direct mechanism by which alterations in DDR contribute to atherogenesis.
Further studies are required to address differential expression across a broader spectrum of genes involved in DDR in coronary artery disease.