Early and ongoing stable glycaemic control is associated with a reduction in major adverse cardiovascular events in people with type 2 diabetes: A primary care cohort study.

AIM: To determine whether achieving early glycaemic control, and any subsequent glycaemic variability, was associated with any change in the risk of major adverse cardiovascular events (MACE). MATERIALS AND METHODS: A retrospective cohort analysis from the Oxford-Royal College of General Practitioners Research and Surveillance Centre database-a large, English primary care network-was conducted. We followed newly diagnosed patients with type 2 diabetes, on or after 1 January 2005, aged 25 years or older at diagnosis, with HbA1c measurements at both diagnosis and after 1 year, plus five or more measurements of HbA1c thereafter. Three glycaemic bands were created: groups A (HbA1c < 58 mmol/mol [<7.5%]), B (HbA1c ≥ 58 to 75 mmol/mol [7.5%-9.0%]) and C (HbA1c ≥ 75 mmol/mol [≥9.0%]). Movement between bands was determined from diagnosis to 1 year. Additionally, for data after the first 12 months, a glycaemic variability score was calculated from the number of successive HbA1c readings differing by 0.5% or higher (≥5.5 mmol/mol). Risk of MACE from 1 year postdiagnosis was assessed using time-varying Cox proportional hazards models, which included the first-year transition and the glycaemic variability score. RESULTS: From 26 180 patients, there were 2300 MACE. Compared with group A->A transition over 1 year, those with C->A transition had a reduced risk of MACE (HR 0.75; 95% CI 0.60-0.94; P = .014), whereas group C->C had HR 1.21 (0.81-1.81; P = .34). Compared with the lowest glycaemic variability score, the greatest variability increased the risk of MACE (HR 1.51; 1.11-2.06; P = .0096). CONCLUSION: Early control of HbA1c improved cardiovascular outcomes in type 2 diabetes, although subsequent glycaemic variability had a negative effect on an individual's risk.

Valproate prescription to women of childbearing age in English primary care: repeated cross-sectional analyses and retrospective cohort study.

BACKGROUND: Valproate is a teratogenic drug that should be avoided during the preconception period and pregnancy. The aim was to explore general practitioners' (GPs) prescription patterns over time, describe trends, and explore inter-practice variation within primary care. METHODS: We identified women of childbearing age (12-46 years old) in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network. We performed repeated cross-sectional analyses from 2004 to 2018 to determine rates of prescription and a retrospective cohort estimated the prevalence of use of valproate during pregnancy. RESULTS: In 2004, 0.31% (95% Confidence Interval (95%CI):0.18 to 0.44%) women were prescribed valproate, decreasing to 0.16% (95%CI:0.07 to 0.24%) by 2018. Among women with epilepsy, the rate fell from 15.2% (95%CI:14.4 to 16.0%) to 8.8% (95% CI:8.2 to 9.7%) over the same period. In 2018, almost two thirds (62.2%) of women who were prescribed valproate had epilepsy only, whereas bipolar disorder and migraine accounted for 15.8% and 7.4% respectively. Contraceptive prescriptions did not increase over time, and only in 2018 was there greater odds of being prescribed contraception (OR 1.41, 95%CI:1.08 to 1.45). Just under a fifth (19.7%) of women were prescribed valproate during their pregnancy; two out of three of these pregnancies were preceded by folic acid prescription (5 mg). While some practices reduced their rate of valproate prescription, others did not. CONCLUSIONS: Regulatory guidelines have changed GPs' prescription patterns in women of childbearing potential for valproate but not for contraception. Further research is needed to identify the barriers of GPs and women of childbearing potential to undertaking contraception.

Disparities in glycaemic control, monitoring, and treatment of type 2 diabetes in England: A retrospective cohort analysis.

BACKGROUND: Disparities in type 2 diabetes (T2D) care provision and clinical outcomes have been reported in the last 2 decades in the UK. Since then, a number of initiatives have attempted to address this imbalance. The aim was to evaluate contemporary data as to whether disparities exist in glycaemic control, monitoring, and prescribing in people with T2D. METHODS AND FINDINGS: A T2D cohort was identified from the Royal College of General Practitioners Research and Surveillance Centre dataset: a nationally representative sample of 164 primary care practices (general practices) across England. Diabetes healthcare provision and glucose-lowering medication use between 1 January 2012 and 31 December 2016 were studied. Healthcare provision included annual HbA1c, renal function (estimated glomerular filtration rate [eGFR]), blood pressure (BP), retinopathy, and neuropathy testing. Variables potentially associated with disparity outcomes were assessed using mixed effects logistic and linear regression, adjusted for age, sex, ethnicity, and socioeconomic status (SES) using the Index of Multiple Deprivation (IMD), and nested using random effects within general practices. Ethnicity was defined using the Office for National Statistics ethnicity categories: White, Mixed, Asian, Black, and Other (including Arab people and other groups not classified elsewhere). From the primary care adult population (n = 1,238,909), we identified a cohort of 84,452 (5.29%) adults with T2D. The mean age of people with T2D in the included cohort at 31 December 2016 was 68.7 ± 12.6 years; 21,656 (43.9%) were female. The mean body mass index was 30.7 ± SD 6.4 kg/m2. The most deprived groups (IMD quintiles 1 and 2) showed poorer HbA1c than the least deprived (IMD quintile 5). People of Black ethnicity had worse HbA1c than those of White ethnicity. Asian individuals were less likely than White individuals to be prescribed insulin (odds ratio [OR] 0.86, 95% CI 0.79-0.95; p < 0.01), sodium-glucose cotransporter-2 (SGLT2) inhibitors (OR 0.68, 95% CI 0.58-0.79; p < 0.001), and glucagon-like peptide-1 (GLP-1) agonists (OR 0.37, 95% CI 0.31-0.44; p < 0.001). Black individuals were less likely than White individuals to be prescribed SGLT2 inhibitors (OR 0.50, 95% CI 0.39-0.65; p < 0.001) and GLP-1 agonists (OR 0.45, 95% CI 0.35-0.57; p < 0.001). Individuals in IMD quintile 5 were more likely than those in the other IMD quintiles to have annual testing for HbA1c, BP, eGFR, retinopathy, and neuropathy. Black individuals were less likely than White individuals to have annual testing for HbA1c (OR 0.89, 95% CI 0.79-0.99; p = 0.04) and retinopathy (OR 0.82, 95% CI 0.70-0.96; p = 0.011). Asian individuals were more likely than White individuals to have monitoring for HbA1c (OR 1.10, 95% CI 1.01-1.20; p = 0.023) and eGFR (OR 1.09, 95% CI 1.00-1.19; p = 0.048), but less likely for retinopathy (OR 0.88, 95% CI 0.79-0.97; p = 0.01) and neuropathy (OR 0.88, 95% CI 0.80-0.97; p = 0.01). The study is limited by the nature of being observational and defined using retrospectively collected data. Disparities in diabetes care may show regional variation, which was not part of this evaluation. CONCLUSIONS: Our findings suggest that disparity in glycaemic control, diabetes-related monitoring, and prescription of newer therapies remains a challenge in diabetes care. Both SES and ethnicity were important determinants of inequality. Disparities in glycaemic control and other areas of care may lead to higher rates of complications and adverse outcomes for some groups.

Identification of people with autosomal dominant polycystic kidney disease using routine data: a cross sectional study.

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

The Relationship between Serum Sodium Concentration and Albuminuria: A Retrospective Cohort Study.

BACKGROUND: Lowering dietary salt intake reduces albuminuria, an early marker of renal damage and a sensitive predictor of adverse cardiovascular outcomes. The mechanisms underlying this effect are uncertain but small changes in serum sodium concentration may be important: this retrospective cohort study investigated the hypothesis that higher serum sodium concentration is a risk factor for albuminuria (defined as a urine albumin:creatinine ratio [UACR], ≥3 mg/mmol). METHODS: Primary care data from the Royal College of General Practitioners Research and Surveillance Centre were used to identify 47,294 individuals with a UACR result available between April 2010 and March 2015, and no known albuminuria prior to this. Exclusion criteria were missing or abnormal serum sodium concentration at baseline (<135 or >146 mmol/L); age <18 years; diabetes mellitus; decompensated liver disease; heart failure; and stage 5 chronic kidney disease. RESULTS: After adjustment for known risk factors, there was a significant "U-shaped" relationship between serum sodium concentration and albuminuria. The lowest risk was associated with a serum sodium of 138-140 mmol/L. In comparison, the risk of albuminuria was 18% higher with a serum sodium of 135-137 mmol/L and 19% higher with a serum sodium of 144-146 mmol/L. There was no association between serum sodium concentration and blood pressure. CONCLUSION: The finding of a positive association between higher serum sodium concentration and albuminuria is in support of the hypothesis, but the inverse relationship between serum sodium concentration and albuminuria at lower concentrations warrants further explanation.

Audit-based education lowers systolic blood pressure in chronic kidney disease: the Quality Improvement in CKD (QICKD) trial results.

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.

Association of chronic kidney disease (CKD) and failure to monitor renal function with adverse outcomes in people with diabetes: a primary care cohort study.

BACKGROUND: 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. METHODS: A cohort of people with type 1 and 2 diabetes (N = 35,502) from the Quality Improvement in Chronic Kidney Disease (QICKD) cluster randomised trial was followed up over 2.5 years. A composite of all-cause mortality, cardiovascular events, and end stage renal failure comprised the outcome measure. A multilevel logistic regression model was used to determine correlates with this outcome. Known cardiovascular and renal risk factors were adjusted for. RESULTS: Proteinuria and reduced estimated glomerular filtration rate (eGFR) were independently associated with adverse outcomes in people with diabetes. People with an eGFR < 60 ml/min, proteinuria, and hypertension have the greatest odds ratio (OR) of adverse outcome; 1.58 (95% CI 1.36-1.83). Renal function was not monitored in 4460 (12.6%) people. Unmonitored renal function was associated with adverse events; OR 1.35 (95% CI 1.13-1.63) in people with hypertension and OR 1.32 (95% CI 1.07-1.64) in those without. CONCLUSIONS: Proteinuria, eGFR < 60 ml/min, and failure to monitor renal function are associated with cardiovascular and renal events and mortality in people with diabetes.

Step-Wise Management of Anemia in Patients With Chronic Kidney Disease in Primary Care: Qualitative Study.

INTRODUCTION: Anemia is common in chronic kidney disease (CKD) and is associated with increased cardiovascular risk and reduced quality of life, but is often sub-optimally managed. Most patients are managed in primary care alongside other comorbidities. Interventions to improve the management of anemia in CKD in this setting are needed. METHODS: We conducted a qualitative study to evaluate how an audit-based education (ABE) intervention might improve the management of anemia in CKD. We explored outcomes that would be relevant to practitioners and patients, that exposed variation of practice from National Institute for Health and Care Excellence (NICE) guidelines, and whether the intervention was feasible and acceptable. RESULTS: Practitioners (n = 5 groups) and patients (n = 7) from 4 London general practices participated in discussions. Practitioners welcomed the evidence-based step-wise intervention. However, prescribing erythropoiesis-stimulating agents (ESAs) was felt to be outside of their scope of practice. There was a gap between NICE guidance and clinical practice in primary care. Iron studies were not well understood and anemia management was often conservative or delayed. Patients were often unaware of having CKD, and were more concerned about their other comorbidities, but largely trusted their GPs to manage them appropriately. CONCLUSIONS: The first steps of the intervention were welcomed by practitioners, but they expressed concerns about independently prescribing ESAs. Renal physicians and GPs could develop shared care protocols for ESA use in primary care. There is scope to improve awareness of renal anemia, and enhance knowledge of guideline recommendations; and our intervention should be modified accordingly.

The Effect of the COVID-19 Pandemic on Glycemic Monitoring and Other Processes of Care for Type 2 Diabetes: Protocol for a Retrospective Cohort Study.

BACKGROUND: Social distancing and other nonpharmaceutical interventions to reduce the spread of COVID-19 infection in the United Kingdom have led to substantial changes in delivering ongoing care for patients with chronic conditions, including type 2 diabetes mellitus (T2DM). Clinical guidelines for the management and prevention of complications for people with T2DM delivered in primary care services advise routine annual reviews and were developed when face-to-face consultations were the norm. The shift in consultations from face-to-face to remote consultations caused a reduction in direct clinical contact and may impact the process of care for people with T2DM. OBJECTIVE: The aim of this study is to explore the impact of the COVID-19 pandemic's first year on the monitoring of people with T2DM using routine annual reviews from a national primary care perspective in England. METHODS: A retrospective cohort study of adults with T2DM will be performed using routinely collected primary care data from the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). We will describe the change in the rate of monitoring of hemoglobin A1c (HbA1c) between the first year of the COVID-19 pandemic (2020) and the preceding year (2019). We will also report any change in the eight checks that make up the components of these reviews. The change in HbA1c monitoring rates will be determined using a multilevel logistic regression model, adjusting for patient and practice characteristics, and similarly, the change in a composite measure of the completeness of all eight checks will be modeled using ordinal regression. The models will be adjusted for the following patient-level variables: age, gender, socioeconomic status, ethnicity, COVID-19 shielding status, duration of diabetes, and comorbidities. The model will also be adjusted for the following practice-level variables: urban versus rural, practice size, Quality and Outcomes Framework achievement, the National Health Service region, and the proportion of face-to-face consultations. Ethical approval was provided by the University of Oxford Medical Sciences Interdivisional Research Ethics Committee (September 2, 2021, reference R77306/RE001). RESULTS: The analysis of the data extract will include 3.96 million patients with T2DM across 700 practices, which is 6% of the available Oxford-RCGP RSC adult population. The preliminary results will be submitted to a conference under the domain of primary care. The resulting publication will be submitted to a peer-reviewed journal on diabetes and endocrinology. CONCLUSIONS: The COVID-19 pandemic has impacted the delivery of care, but little is known about the process of caring for people with T2DM. This study will report the impact of the COVID-19 pandemic on these processes of care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35971.

Creatinine fluctuation has a greater effect than the formula to estimate glomerular filtration rate on the prevalence of chronic kidney disease.

BACKGROUND/AIMS: 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. SAMPLE: Of 930,997 registered patients, 36% (332,891) have their eGFR defined (63% of those aged 50-74 years, 81% >75 years). RESULTS: The prevalence of stage 3-5 CKD is 5.41% (n = 50,331). (1) Not including ethnicity data the prevalence would be 5.49%, (2) just using the latest eGFR 6.4%, (3) excluding intermediary values 5.55% and (4) using the CKD-EPI equation 4.8%. All changes in eGFR (t test) and the proportion with CKD (χ(2) test) were significant (p < 0.001). Using serum-creatinine-calculated eGFR instead of laboratory data reduced the prevalence of stage 3-5 CKD by around 0.01%. Sixty-six percent of people with stage 3-5 disease have cardiovascular disease and 4.0% significant proteinuria using the MDRD formula; the corresponding figures using CKD-EPI are 74 and 4.6%. CONCLUSIONS: A standardised approach to reporting case finding would allow a better comparison of prevalence estimates. Using a single eGFR tends to inflate the reported prevalence of CKD by ignoring creatinine fluctuation; this effect is greater than the difference between MDRD and CKD-EPI.

Confidence and quality in managing CKD compared with other cardiovascular diseases and diabetes mellitus: a linked study of questionnaire and routine primary care data.

BACKGROUND: Much of chronic disease is managed in primary care and chronic kidney disease (CKD) is a recent addition. We are conducting a cluster randomised study of quality improvement interventions in CKD (QICKD) - Clinical Trials Registration: ISRCTN56023731. CKD registers have a lower than expected prevalence and an initial focus group study suggested variable levels of confidence in managing CKD. Our objective is to compare practitioner confidence and achievement of quality indicators for CKD with hypertension and diabetes. METHOD: We validated a new questionnaire to test confidence. We compared confidence with achievement of pay-for-performance indicators (P4P) and implementation of evidence-based guidance. We achieved a 74% (148/201) response rate. RESULTS: 87% (n = 128) of respondents are confident in managing hypertension (HT) compared with 59% (n = 87) in managing HT in CKD (HT+CKD); and with 61% (n = 90) in HT, CKD and diabetes (CKD+HT+DM). 85.2% (P4P) and 62.5% (National targets) of patients with hypertension are at target; in patients with HT and CKD 65.1% and 53.3%; in patients with HT, CKD and DM 67.8% and 29.6%. Confidence in managing proteinuria in CKD is low (42%, n = 62). 87% of respondents knew BP treatment thresholds in CKD, but only 53% when proteinuria is factored in. Male GPs, younger (< 35 yrs), and older (> 54 yrs) clinicians are more confident than females and 35 to 54 year olds in managing CKD. 84% of patients with hypertension treated with angiotensin modulating drugs achieve achieved P4P targets compared to 67% of patients with CKD. CONCLUSIONS: Practitioners are less likely to achieve management targets where their confidence is low.

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.

BACKGROUND: 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. OBJECTIVE: To use routinely collected data to determine whether a leaflet campaign to raise awareness of memory problems would result in increased presentation of people with memory problems to their GPs. METHOD: A locality was identified which met the criteria for locating the pilot intervention. A neighbouring locality was identified which used the same secondary care service and could serve as a comparator. Anonymised routinely collected computer data were gathered before and after the intervention. RESULTS: The intervention locality had a much greater proportion of elderly patients and a higher proportion had memory problems recorded at baseline (OR 1.67; 95% CI 1.47-1.91; P<0.001). In both localities just under 40% of people with memory problems had blood tests. Approximately 80% would be referred to secondary care, and this was more likely for those in the intervention group (OR 1.29; 95% CI 0.99-1.93; P=0.044). However, the use of antidepressants was greater in the control locality; 34% vs 9% (OR 0.19; 95% CI 0.13-0.27; P<0.001). Whilst the absolute number of people prescribed cholinesterase inhibitors was greater and increased more in the intervention practices, the proportion of people with memory problems prescribed was not significantly greater (OR 1.21; 95% CI 0.77-1.89; P=0.38). The increased prescribing in the intervention practices was due to people restarting therapy. From a lower baseline there was a greater increase in the control locality for all variables for which we had a before and after measure. CONCLUSIONS: During a leaflet campaign the recording and management of memory problems increased. However, there was greater improvement in the control locality. This study demonstrates the importance of including a control group and the strengths of routine primary care data.

A system for solution-orientated reporting of errors associated with the extraction of routinely collected clinical data for research and quality improvement.

BACKGROUND: 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. OBJECTIVE: To develop a solution-orientated system of error reporting which enables appropriate corrective action. METHOD: Review of the 94 errors, which occurred in 2008/9. Previously we had described failures in terms of the data missing from our response files; however this provided little information about causation. We therefore developed a taxonomy based on the IT component limiting data extraction. RESULTS: Our final taxonomy categorised errors as: (A) Data extraction Method and Process; (B) Translation Layer and Proxy Specification; (C) Shape and Complexity of the Original Schema; (D) Communication and System (mainly Software-based) Faults; (E) Hardware and Infrastructure; (F) Generic/Uncategorised and/or Human Errors. We found 79 distinct errors among the 94 reported; and the categories were generally predictive of the time needed to develop fixes. CONCLUSIONS: A systematic approach to errors and linking them to problem solving has improved project efficiency and enabled us to better predict any associated delays.

Reorganisation of primary care for older adults during COVID-19: a cross-sectional database study in the UK.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in a rapid change in workload across healthcare systems. Factors related to this adaptation in UK primary care have not yet been examined. AIM: To assess the responsiveness and prioritisation of primary care consultation type for older adults during the COVID-19 pandemic. DESIGN AND SETTING: A cross-sectional database study examining consultations between 17 February and 10 May 2020 for patients aged ≥65 years, drawn from primary care practices within the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network, UK. METHOD: The authors reported the proportion of consultation type across five categories: clinical administration, electronic/video, face-to-face, telephone, and home visits. Temporal trends in telephone and face-to-face consultations were analysed by polypharmacy, frailty status, and socioeconomic group using incidence rate ratios (IRR). RESULTS: Across 3 851 304 consultations, the population median age was 75 years (interquartile range [IQR] 70-82); and 46% (n = 82 926) of the cohort (N = 180 420) were male. The rate of telephone and electronic/video consultations more than doubled across the study period (106.0% and 102.8%, respectively). Face-to-face consultations fell by 64.6% and home visits by 62.6%. This predominantly occurred across week 11 (week commencing 9 March 2020), coinciding with national policy change. Polypharmacy and frailty were associated with a relative increase in consultations. The greatest relative increase was among people taking ≥10 medications compared with those taking none (face-to-face IRR 9.90, 95% CI = 9.55 to 10.26; telephone IRR 17.64, 95% CI = 16.89 to 18.41). CONCLUSION: Primary care has undergone an unprecedented in-pandemic reorganisation while retaining focus on patients with increased complexity.

The association between serum sodium concentration, hypertension and primary cardiovascular events: a retrospective cohort study.

The mechanisms underlying the adverse cardiovascular effects of increased salt intake are incompletely understood, but parallel increases in serum sodium concentration may be of importance. The aim of this retrospective cohort study was to investigate the relationship between serum sodium, hypertension and incident cardiovascular disease (CVD). Routinely collected primary care data from the Royal College of General Practitioners Research and Surveillance Centre were analysed. A total of 231,545 individuals with a measurement of serum sodium concentration at baseline were included. Exclusion criteria were: age < 40 years; abnormal serum sodium; diabetes mellitus; prior CVD event; stage 5 chronic kidney disease; and liver cirrhosis. The primary outcome was incident CVD (myocardial infarction, acute coronary syndrome, coronary revascularisation, stroke, transient ischaemic attack or new heart failure diagnosis) over 5 years. There was a 'J-shaped' relationship between serum sodium concentration and primary cardiovascular events that was independent of established risk factors, medications and other serum electrolytes. The lowest cardiovascular risk was found with a serum sodium between 141 and 143 mmol/l. Higher serum sodium was associated with increased risk in hypertensive individuals, whereas lower concentrations were associated with increased risk in all individuals. Therefore, alterations in serum sodium concentration may be a useful indicator of CVD risk. Higher serum sodium could have a direct effect on the vasculature, particularly in hypertensive individuals. Lower serum sodium may be a reflection of complex volume and neuroendocrine changes.

The ALFA (Activity Log Files Aggregation) toolkit: a method for precise observation of the consultation.

BACKGROUND: There is a lack of tools to evaluate and compare Electronic patient record (EPR) systems to inform a rational choice or development agenda. OBJECTIVE: To develop a tool kit to measure the impact of different EPR system features on the consultation. METHODS: We first developed a specification to overcome the limitations of existing methods. We divided this into work packages: (1) developing a method to display multichannel video of the consultation; (2) code and measure activities, including computer use and verbal interactions; (3) automate the capture of nonverbal interactions; (4) aggregate multiple observations into a single navigable output; and (5) produce an output interpretable by software developers. We piloted this method by filming live consultations (n = 22) by 4 general practitioners (GPs) using different EPR systems. We compared the time taken and variations during coded data entry, prescribing, and blood pressure (BP) recording. We used nonparametric tests to make statistical comparisons. We contrasted methods of BP recording using Unified Modeling Language (UML) sequence diagrams. RESULTS: We found that 4 channels of video were optimal. We identified an existing application for manual coding of video output. We developed in-house tools for capturing use of keyboard and mouse and to time stamp speech. The transcript is then typed within this time stamp. Although we managed to capture body language using pattern recognition software, we were unable to use this data quantitatively. We loaded these observational outputs into our aggregation tool, which allows simultaneous navigation and viewing of multiple files. This also creates a single exportable file in XML format, which we used to develop UML sequence diagrams. In our pilot, the GP using the EMIS LV (Egton Medical Information Systems Limited, Leeds, UK) system took the longest time to code data (mean 11.5 s, 95% CI 8.7-14.2). Nonparametric comparison of EMIS LV with the other systems showed a significant difference, with EMIS PCS (Egton Medical Information Systems Limited, Leeds, UK) (P = .007), iSoft Synergy (iSOFT, Banbury, UK) (P = .014), and INPS Vision (INPS, London, UK) (P = .006) facilitating faster coding. In contrast, prescribing was fastest with EMIS LV (mean 23.7 s, 95% CI 20.5-26.8), but nonparametric comparison showed no statistically significant difference. UML sequence diagrams showed that the simplest BP recording interface was not the easiest to use, as users spent longer navigating or looking up previous blood pressures separately. Complex interfaces with free-text boxes left clinicians unsure of what to add. CONCLUSIONS: The ALFA method allows the precise observation of the clinical consultation. It enables rigorous comparison of core elements of EPR systems. Pilot data suggests its capacity to demonstrate differences between systems. Its outputs could provide the evidence base for making more objective choices between systems.

Assessing the impact of recording quality target data on the GP consultation using multi-channel video.

BACKGROUND: In the UK routinely collected computerized clinical data is used to assess progress towards financially incentivised quality targets for chronic disease management including hypertension. OBJECTIVE: To develop a method for assessing the impact of recording quality target data in the clinical consultation. METHODS: Raters were trained how to rate a multi-channel video of a simulated clinical consultation for interaction between actors, computer use, non-verbal communication. RESULTS: 25% of consultation time is computer use and a median of 4 to 5 items were coded per consultation mainly items related to the hypertension quality target. Intraclass correlation coefficient showed good inter-rater reliability (>0.9; p<0.001). CONCLUSION: We have successfully piloted a novel technique for observing the influence of the computer on the consultation. Despite increasing computer use to record quality target data the overwhelming proportion of the consultation remains doctor patient interaction.

Ethnicity Recording in Primary Care Computerised Medical Record Systems: An Ontological Approach.

BACKGROUND: Ethnicity recording within primary care computerised medical record (CMR) systems is suboptimal, exacerbated by tangled taxonomies within current coding systems.Objective To develop a method for extending ethnicity identification using routinely collected data. METHODS: We used an ontological method to maximise the reliability and prevalence of ethnicity information in the Royal College of General Practitioner's Research and Surveillance database. Clinical codes were either directly mapped to ethnicity group or utilised as proxy markers (such as language spoken) from which ethnicity could be inferred. We compared the performance of our method with the recording rates that would be identified by code lists utilised by the UK pay for the performance system, with the help of the Quality and Outcomes Framework (QOF). RESULTS: Data from 2,059,453 patients across 110 practices were included. The overall categorisable ethnicity using QOF codes was 36.26% (95% confidence interval (CI): 36.20%-36.33%). This rose to 48.57% (CI:48.50%-48.64%) using the described ethnicity mapping process. Mapping increased across all ethnic groups. The largest increase was seen in the white ethnicity category (30.61%; CI: 30.55%-30.67% to 40.24%; CI: 40.17%-40.30%). The highest relative increase was in the ethnic group categorised as the other (0.04%; CI: 0.03%-0.04% to 0.92%; CI: 0.91%-0.93%). CONCLUSIONS: This mapping method substantially increases the prevalence of known ethnicity in CMR data and may aid future epidemiological research based on routine data.

An Ontology to Improve Transparency in Case Definition and Increase Case Finding of Infectious Intestinal Disease: Database Study in English General Practice.

BACKGROUND: Infectious intestinal disease (IID) has considerable health impact; there are 2 billion cases worldwide resulting in 1 million deaths and 78.7 million disability-adjusted life years lost. Reported IID incidence rates vary and this is partly because terms such as "diarrheal disease" and "acute infectious gastroenteritis" are used interchangeably. Ontologies provide a method of transparently comparing case definitions and disease incidence rates. OBJECTIVE: This study sought to show how differences in case definition in part account for variation in incidence estimates for IID and how an ontological approach provides greater transparency to IID case finding. METHODS: We compared three IID case definitions: (1) Royal College of General Practitioners Research and Surveillance Centre (RCGP RSC) definition based on mapping to the Ninth International Classification of Disease (ICD-9), (2) newer ICD-10 definition, and (3) ontological case definition. We calculated incidence rates and examined the contribution of four supporting concepts related to IID: symptoms, investigations, process of care (eg, notification to public health authorities), and therapies. We created a formal ontology using ontology Web language. RESULTS: The ontological approach identified 5712 more cases of IID than the ICD-10 definition and 4482 more than the RCGP RSC definition from an initial cohort of 1,120,490. Weekly incidence using the ontological definition was 17.93/100,000 (95% CI 15.63-20.41), whereas for the ICD-10 definition the rate was 8.13/100,000 (95% CI 6.70-9.87), and for the RSC definition the rate was 10.24/100,000 (95% CI 8.55-12.12). Codes from the four supporting concepts were generally consistent across our three IID case definitions: 37.38% (3905/10,448) (95% CI 36.16-38.5) for the ontological definition, 38.33% (2287/5966) (95% CI 36.79-39.93) for the RSC definition, and 40.82% (1933/4736) (95% CI 39.03-42.66) for the ICD-10 definition. The proportion of laboratory results associated with a positive test result was 19.68% (546/2775). CONCLUSIONS: The standard RCGP RSC definition of IID, and its mapping to ICD-10, underestimates disease incidence. The ontological approach identified a larger proportion of new IID cases; the ontology divides contributory elements and enables transparency and comparison of rates. Results illustrate how improved diagnostic coding of IID combined with an ontological approach to case definition would provide a clearer picture of IID in the community, better inform GPs and public health services about circulating disease, and empower them to respond. We need to improve the Pathology Bounded Code List (PBCL) currently used by laboratories to electronically report results. Given advances in stool microbiology testing with a move to nonculture, PCR-based methods, the way microbiology results are reported and coded via PBCL needs to be reviewed and modernized.

Routinely-collected general practice data are complex, but with systematic processing can be used for quality improvement and research.

BACKGROUND: UK general practice is computerised, and quality targets based on computer data provide a further incentive to improve data quality. A National Programme for Information Technology is standardising the technical infrastructure and removing some of the barriers to data aggregation. Routinely collected data is an underused resource, yet little has been written about the wide range of factors that need to be taken into account if we are to infer meaning from general practice data. OBJECTIVE: To report the complexity of general practice computer data and factors that need to be taken into account in its processing and interpretation. METHOD: We run clinically focused programmes that provide clinically relevant feedback to clinicians, and overview statistics to localities and researchers. However, to take account of the complexity of these data we have carefully devised a system of process stages and process controls to maintain referential integrity, and improve data quality and error reduction. These are integrated into our design and processing stages. Our systems document the query, reference code set and create unique patient ID. The design stage is followed by appraisal of: data entry issues, how concepts might be represented in clinical systems, coding ambiguities, using surrogates where needed, validation and pilot-ing. The subsequent processing of data includes extraction, migration and integration of data from different sources, cleaning, processing and analysis. RESULTS: Results are presented to illustrate issues with the population denominator, data entry problems, identification of people with unmet needs, and how routine data can be used for real-world testing of pharmaceuticals. CONCLUSIONS: Routinely collected primary care data could contribute more to the process of health improvement; however, those working with these data need to understand fully the complexity of the context within which data entry takes place.