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The roles of policy and professionalism in the protection of processed clinical data: A literature review
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. © 2005 Elsevier Ireland Ltd. All rights reserved.
Assessing the prevalence, monitoring and management of chronic kidney disease in patients with diabetes compared with those without diabetes in general practice
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 < 60 ml/min per 1.73 m 2; CKD stages 3-5) compared with 6.9% of those without diabetes. Only 33% of patients with diabetes at CKD stage 3 had serum creatinine > 120 μmol/l. Of patients with diabetes with eGFR < 60 ml/min per 1.73 m 2, 63% had normoalbuminuria. Considering those with eGFR 30-60 ml/min per 1.73 m2, 42% of people with diabetes were on an ACE inhibitor compared with 25% of those without diabetes; 32% of patients with diabetes who had any record of micro- or macroalbuminuria at CKD stage 3 were taking an ACE inhibitor. Of people with diabetes and hypertension (BP > 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. © 2007 The Authors.
The use of routinely collected computer data for research in primary care: Opportunities and challenges
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. © 2006 Oxford University Press.
End-digit preference in blood pressure recordings of patients with ischaemic heart disease in primary care
End-digit preference describes the disproportionate selection of specific end digits. The rounding of figures might lead to either an under- or over-recording of blood pressure (BP) and a lack of accuracy and reliability in treatment decisions. A total of 85 000 BP values taken from computerised general practice records of ischaemic heart disease patients in England between 2001 and 2003 were examined. Zero preference accounts for 64% of systolic and 59% of diastolic readings, compared with an expected frequency of 10% (P<0.000001). Even numbers are more frequently seen than odd numbers. In all, 64% of nonzero systolic recordings and 65% of diastolic recordings ended in even numbers, compared with expected proportions of 44% (P<0.0001). Among the nonzero even numbers, eight is the most frequently observed: 28% of systolic and 31% of diastolic recordings compared with an expected proportion of 25% (P<0.0001). Among the five nonzero odd numbers, five is the most frequently observed end digit, representing 59% systolic and 62% of diastolic compared with an expected level of 20% (P<0.00001). English general practice displays marked end-digit preference. This is strongly for the end-digit zero. However, there is more use of other enddigits, notably 8 and 5. This bias potentially carries important treatment consequences for this high-risk population. © 2004 Nature Publishing Group All rights reserved.
The effectiveness of blood tests in detecting secondary osteoporosis or mimicking conditions in postmenopausal women
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.
© © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Background Rapidly undertaken age-stratified serology studies can produce valuable data about a new emerging infection including background population immunity and seroincidence during an influenza pandemic. Traditionally seroepidemiology studies have used surplus laboratory sera with little or no clinical information or have been expensive detailed population based studies. We propose collecting population based sera from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), a sentinel network with extensive clinical data. Aim To pilot a mechanism to undertake population based surveys that collect serological specimens and associated patient data to measure seropositivity and seroincidence due to seasonal influenza, and create a population based serology bank. Methods and analysis Setting and Participants: We will recruit 6 RCGP RSC practices already taking nasopharyngeal virology swabs. Patients who attend a scheduled blood test will be consented to donate additional blood samples. Approximately 100-150 blood samples will be collected from each of the following age bands-18-29, 30-39, 40-49, 50-59, 60-69 and 70+ years. Methods We will send the samples to the Public Health England (PHE) Seroepidemiology Unit for processing and storage. These samples will be tested for influenza antibodies, using haemagglutination inhibition assays. Serology results will be pseudonymised, sent to the RCGP RSC and combined using existing processes at the RCGP RSC secure hub. The influenza seroprevalence results from the RCGP cohort will be compared against those from the annual PHE influenza residual serosurvey. Ethics and dissemination Ethical approval was granted by the Proportionate Review Sub-Committee of the London-Camden & Kings Cross on 6 February 2018. This study received approval from Health Research Authority on 7 February 2018. On completion the results will be made available via peer-reviewed journals.
Interim 2017/18 influenza seasonal vaccine effectiveness: Combined results from five European studies
© the authors, 2018. Between September 2017 and February 2018, influenza A(H1N1)pdm09, A(H3N2) and B viruses (mainly B/Yamagata, not included in 2017/18 trivalent vaccines) co-circulated in Europe. Interim results from five European studies indicate that, in all age groups, 2017/18 influenza vaccine effectiveness was 25 to 52% against any influenza, 55 to 68% against influenza A(H1N1)pdm09, -42 to 7% against influenza A(H3N2) and 36 to 54% against influenza B. 2017/18 influenza vaccine should be promoted where influenza still circulates.
Effectiveness of an intervention to facilitate prompt referral to memory clinics in the United Kingdom: Cluster randomised controlled trial
© 2017 Livingston et al. Background: Most people with dementia do not receive timely diagnosis, preventing them from making informed plans about their future and accessing services. Many countries have a policy to increase timely diagnosis, but trials aimed at changing general practitioner (GP) practice have been unsuccessful. We aimed to assess whether a GP’s personal letter, with an evidence-based leaflet about overcoming barriers to accessing help for memory problems—aimed at empowering patients and families—increases timely dementia diagnosis and patient presentation to general practice. Methods and finding: Multicentre, cluster-randomised controlled trial with raters masked to an online computer-generated randomisation system assessing 1 y outcome. We recruited 22 general practices (August 2013–September 2014) and 13 corresponding secondary care memory services in London, Hertfordshire, and Essex, United Kingdom. Eligible patients were aged ≥70 y, without a known diagnosis of dementia, living in their own homes. There were 6,387 such patients in 11 intervention practices and 8,171 in the control practices. The primary outcome was cognitive severity on Mini Mental State Examination (MMSE). Main secondary outcomes were proportion of patients consulting their GP with suspected memory disorders and proportion of those referred to memory clinics. There was no between-group difference in cognitive severity at diagnosis (99 intervention, mean MMSE = 22.04, 95% confidence intervals (CIs) = 20.95 to 23.13; 124 control, mean MMSE = 22.59, 95% CI = 21.58 to 23.6; p = 0.48). GP consultations with patients with suspected memory disorders increased in intervention versus control group (odds ratio = 1.41; 95% CI = 1.28, 1.54). There was no between-group difference in the proportions of patients referred to memory clinics (166, 2.5%; 220, 2.7%; p =.077 respectively). The study was limited as we do not know whether the additional patients presenting to GPs had objective as well as subjective memory problems and therefore should have been referred. In addition, we aimed to empower patients but did not do anything to change GP practice. Conclusions: Our intervention to access timely dementia diagnosis resulted in more patients presenting to GPs with memory problems, but no diagnoses increase. We are uncertain as to the reason for this and do not know whether empowering the public and targeting GPs would have resulted in a successful intervention. Future interventions should be targeted at both patients and GPs. Trial registration: Current Controlled Trials ISRCTN19216873
Aims To develop a computer processable algorithm, capable of running automated searches of routine data that flag miscoded and misclassified cases of diabetes for subsequent clinical review. Method Anonymized computer data from the Quality Improvement in Chronic Kidney Disease (QICKD) trial (n=942031) were analysed using a binary method to assess the accuracy of data on diabetes diagnosis. Diagnostic codes were processed and stratified into: definite, probable and possible diagnosis of Type 1 or Type 2 diabetes. Diagnostic accuracy was improved by using prescription compatibility and temporally sequenced anthropomorphic and biochemical data. Bayesian false detection rate analysis was used to compare findings with those of an entirely independent and more complex manual sort of the first round QICKD study data (n=760588). Results The prevalence of definite diagnosis of Type 1 diabetes and Type 2 diabetes were 0.32% and 3.27% respectively when using the binary search method. Up to 35% of Type 1 diabetes and 0.1% of Type 2 diabetes were miscoded or misclassified on the basis of age/BMI and coding. False detection rate analysis demonstrated a close correlation between the new method and the published hand-crafted sort. Both methods had the highest false detection rate values when coding, therapeutic, anthropomorphic and biochemical filters were used (up to 90% for the new and 75% for the hand-crafted search method). Conclusions A simple computerized algorithm achieves very similar results to more complex search strategies to identify miscoded and misclassified cases of both Type 1 diabetes and Type 2 diabetes. It has the potential to be used as an automated audit instrument to improve quality of diabetes diagnosis. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.
Using Unified Modelling Language (UML) as a process-modelling technique for clinical-research process improvement
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.
The 'rule of halves' still applies to the management of cholesterol in cardiovascular disease: 2002-2005
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.
A knowledge audit of the managers of primary care organizations: Top priority is how to use routinely collected clinical data for quality improvement
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. © 2005 Taylor & Francis Group Ltd.
A Class Comparison of Medication Persistence in People with Type 2 Diabetes: A Retrospective Observational Study
© 2018, The Author(s). Introduction: 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. The objective of this study was to compare medication persistence across different oral therapies in people with T2D. Methods: We performed a retrospective cohort analysis using a primary-care-based population, the Royal College of General Practitioners Research and Surveillance Centre cohort. We identified new prescriptions for oral diabetes medication in people with type 2 diabetes between January 1, 2004 and July 31, 2015. We compared median persistence across each class. We also compared non-persistence (defined as a prescription gap of ≥ 90 days) between classes, adjusting for confounders, using Cox regression. Confounders included: age, gender, ethnicity, socioeconomic status, alcohol use, smoking status, glycaemic control, diabetes duration, diabetes complications, comorbidities, and number of previous and concurrent diabetes medications. Results: We identified 60,327 adults with T2D. The majority 42,810 (70.9%) of those had one or more oral medications prescribed; we measured persistence in those patients (who were prescribed 55,728 oral medications in total). Metformin had the longest median persistence (3.04 years; 95% CI 2.94–3.12). The adjusted hazard ratios for non-persistence compared with metformin were: sulfonylureas HR 1.20 (1.16–1.24), DPP-4 inhibitors HR 1.43 (1.38–1.49), thiazolidinediones HR 1.71 (95% CI 1.64–1.77), SGLT2 inhibitors HR 1.04 (0.93–1.17), meglitinides HR 2.25 (1.97–2.58), and alpha-glucosidase inhibitors HR 2.45 (1.98–3.02). 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 were female gender, younger age, and non-white ethnicity. Conclusions: Persistence is strongly influenced by medication class and should be considered when initiating treatments.
Evaluation of the effect of the herpes zoster vaccination programme 3 years after its introduction in England: a population-based study
© 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background: In 2013, a herpes zoster vaccination programme was introduced in England for adults aged 70 years with a phased catch-up programme for those aged 71–79 years. We aimed to evaluate the effect of the first 3 years of the vaccination programme on incidence of herpes zoster and postherpetic neuralgia in this population. Methods: In this population-based study, we extracted data from the Royal College of General Practitioners sentinel primary care network on consultations with patients aged 60–89 years for herpes zoster and postherpetic neuralgia occurring between Oct 1, 2005, and Sept 30, 2016, obtaining data from 164 practices. We identified individual data on herpes zoster vaccinations administered and consultations for herpes zoster and postherpetic neuralgia, and aggregated these data to estimate vaccine coverage and incidence of herpes zoster and postherpetic neuralgia consultations. We defined age cohorts to identify participants targeted in each year of the programme, and as part of the routine or catch-up programme. We modelled incidence according to age, region, gender, time period, and vaccine eligibility using multivariable Poisson regression with an offset for person-years. Findings: Our analysis included 3·36 million person-years of data, corresponding to an average of 310 001 patients aged 60–89 years who were registered at an RCGP practice each year. By Aug 31, 2016, uptake of the vaccine varied between 58% for the recently targeted cohorts and 72% for the first routine cohort. Across the first 3 years of vaccination for the three routine cohorts, incidence of herpes zoster fell by 35% (incidence rate ratio 0·65 [95% 0·60–0·72]) and of postherpetic neuralgia fell by 50% (0·50 [0·38–0·67]). The equivalent reduction for the four catch-up cohorts was 33% for herpes zoster (incidence rate ratio 0·67 [0·61–0·74]) and 38% for postherpetic neuralgia (0·62 [0·50–0·79]). These reductions are consistent with a vaccine effectiveness of about 62% against herpes zoster and 70–88% against postherpetic neuralgia. Interpretation: The herpes zoster vaccination programme in England has had a population impact equivalent to about 17 000 fewer episodes of herpes zoster and 3300 fewer episodes of postherpetic neuralgia among 5·5 million eligible individuals in the first 3 years of the programme. Communication of the public health impact of this programme will be important to reverse the recent trend of declining vaccine coverage. Funding: Public Health England.
Seasonality and geographical spread of respiratory syncytial virus epidemics in 15 european countries, 2010 to 2016
© 2018, European Centre for Disease Prevention and Control (ECDC). All rights reserved. Respiratory syncytial virus (RSV) is considered the most common pathogen causing severe lower respiratory tract infections among infants and young children. We describe the seasonality and geographical spread of RSV infection in 15 countries of the European Union and European Economic Area. We performed a retrospective descriptive study of weekly laboratory-confirmed RSV detections between weeks 40/2010 and 20/2016, in patients investigated for influenza-like illness, acute respiratory infection or following the clinician’s judgment. Six countries reported 4,230 sentinel RSV laboratory diagnoses from primary care and 14 countries reported 156,188 non-sentinel laboratory diagnoses from primary care or hospitals. The median length of the RSV season based on sentinel and non-sentinel surveillance was 16 (range: 9–24) and 18 (range: 8–24) weeks, respectively. The median peak weeks for sentinel and non-sentinel detections were week 4 (range: 48 to 11) and week 4.5 (range: 49 to 17), respectively. RSV detections peaked later (r = 0.56; p = 0.0360) and seasons lasted longer with increasing latitude (r = 0.57; p = 0.0329). Our data demonstrated regular seasonality with moderate correlation between timing of the epidemic and increasing latitude of the country. This study supports the use of RSV diagnostics within influenza or other surveillance systems to monitor RSV seasonality and geographical spread.