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A Full Blood Count (FBC) is a common blood test including 20 parameters, such as haemoglobin and platelets. FBCs from Electronic Health Record (EHR) databases provide a large sample of anonymised individual patient data and are increasingly used in research. We describe the quality of the FBC data in one EHR. The Test dataset from the Clinical Research Practice Datalink (CPRD) was accessed, which contains results of tests performed in primary care, such as FBC blood tests. Medical codes and entity codes, two coding systems used within CPRD to identify FBC records, were compared, with levels of mismatched coding, and number that could be rectified reported. The reliability of units of measurement are also described and missing data discussed. There were 14 entity codes and 138 medical codes for the FBC in the data. Medical and entity codes consistently corresponded to the same FBC parameter in 95.2% (n = 217,752,448) of parameters. In the 4.8% (n = 10,955,006) mismatches, the most common parameter rectified was mean platelet volume (n = 2,041,360) and 1,191,540 could not be rectified and were removed. Units of measurement were often either missing, partially entered, or did not appear to correspond to the blood value. The final dataset contained 16,537,017 FBC tests. Applying mathematical equations to derive some missing parameters in these FBCs resulted in 15 of 20 parameters available per FBC on average, with 0.3% of FBCs having all 20 parameters. Performing data quality checks can help to understand the extent of any issues in the dataset. We emphasise balancing large sample sizes with reliability of the data.

Introduction A full blood count (FBC) blood test includes 20 components. We systematically reviewed studies that assessed the association of the FBC and diagnosis of colorectal cancer to identify components as risk factors. We reviewed FBC-based prediction models for colorectal cancer risk. Methods: MEDLINE, EMBASE, CINAHL, and Web of Science were searched until 3 September 2019. We meta-analysed the mean difference in FBC components between those with and without a diagnosis and critically appraised the development and validation of FBC-based prediction models. Results We included 53 eligible articles. Three of four meta-analysed components showed an association with diagnosis. In the remaining 16 with insufficient data for meta-analysis, three were associated with colorectal cancer. Thirteen FBC-based models were developed. Model performance was commonly assessed using the c-statistic (range 0.72–0.91) and calibration plots. Some models appeared to work well for early detection but good performance may be driven by early events. Conclusion Red blood cells, haemoglobin, mean corpuscular volume, red blood cell distribution width, white blood cell count, and platelets are associated with diagnosis and could be used for referral. Existing FBC-based prediction models might not perform as well as expected and need further critical testing.

BackgroundThe complexity of general practice consultations may be increasing and varies in different settings. A measure of complexity is required to test these hypotheses.AimTo develop a valid measure of general practice consultation complexity applicable to routine medical records.Design and settingDelphi study to select potential indicators of complexity followed by a cross-sectional study in English general practices to develop and validate a complexity measure.MethodThe online Delphi study over two rounds identified potential indicators of consultation complexity. The cross-sectional study used an age–sex stratified random sample of patients and general practice face-to-face consultations from 2013/2014 in the Clinical Practice Research Datalink. The authors explored independent relationships between each indicator and consultation duration using mixed-effects regression models, and revalidated findings using data from 2017/2018. The proportion of complex consultations in different age–sex groups was assessed.ResultsA total of 32 GPs participated in the Delphi study. The Delphi panel endorsed 34 of 45 possible complexity indicators after two rounds. After excluding factors because of low prevalence or confounding, 17 indicators were retained in the cross-sectional study. The study used data from 173 130 patients and 725 616 face-to-face GP consultations. On defining complexity as the presence of any of these 17 factors, 308 370 consultations (42.5%) were found to be complex. Mean duration of complex consultations was 10.49 minutes, compared to 9.64 minutes for non-complex consultations. The proportion of complex consultations was similar in males and females but increased with age.ConclusionThe present consultation complexity measure has face and construct validity. It may be useful for research, management and policy, and for informing decisions about the range of resources needed in different practices.

ObjectiveMost current cardiovascular disease (CVD) risk stratification tools are for people without CVD, but very few are for prevalent CVD. In this study, we developed and validated a CVD severity score in people with coronary heart disease (CHD) and evaluated the association between severity and adverse outcomes.MethodsPrimary and secondary care data for 213 088 people with CHD in 398 practices in England between 2007 and 2017 were used. The cohort was randomly divided into training and validation datasets (80%/20%) for the severity model. Using 20 clinical severity indicators (each assigned a weight=1), baseline and longitudinal CVD severity scores were calculated as the sum of indicators. Adjusted Cox and competing-risk regression models were used to estimate risks for all-cause and cause-specific hospitalisation and mortality.ResultsMean age was 64.5±12.7 years, 46% women, 16% from deprived areas, baseline severity score 1.5±1.2, with higher scores indicating a higher burden of disease. In the training dataset, 138 510 (81%) patients were hospitalised at least once, and 39 944 (23%) patients died. Each 1-unit increase in baseline severity was associated with 41% (95% CI 37% to 45%, area under the receiver operating characteristics (AUROC) curve=0.79) risk for 1 year for all-cause mortality; 59% (95% CI 52% to 67%, AUROC=0.80) for cardiovascular (CV)/diabetes mortality; 27% (95% CI 26% to 28%) for any-cause hospitalisation and 37% (95% CI 36% to 38%) for CV/diabetes hospitalisation. Findings were consistent in the validation dataset.ConclusionsHigher CVD severity score is associated with higher risks for any-cause and cause-specific hospital admissions and mortality in people with CHD. Our reproducible score based on routinely collected data can help practitioners better prioritise management of people with CHD in primary care.

High Mountain Disease (HMD) in cattle is a consequence of altitude-induced (> 1500 m) pulmonary hypertension (PH). Pulmonary arterial pressure (PAP; mmHg) is an indicator of PH-HMD and moderately heritable. This study analyzed repeated measures of PAP in growing bulls and estimated correlations across elevations and ages. Data included breed, PAP, elevation, weights and ages in spring-born bulls from the Agriculture Research, Development, and Education Center (ARDEC) in Colorado. Five PAP measurements were collected from each bull: 1) Weaning PAP at ARDEC (1,525 m); 2) Yearling PAP at ARDEC (i.e., gain-test); 3) PAP after acclimating for 28 days at Fort Lewis College (FLC; 2,470 m); 4) before returning to ARDEC from FLC after 110 days of grazing; and 5) after re-acclimating for 57 days to the moderate elevation and feeding systems at ARDEC when bulls were 18 months of age. Across these 5 times in Angus (n = 18) and Hereford (n = 12) bulls, PAP measures were: 1) 37.97 ± 0.37; 2) 40.93 ± 0.77; 3) 46.10 ± 1.48; 4) 45.00 ± 1.11; and 5) 42.23 ± 0.67, respectively. Breed and elevation-age were important (P < 0.05) sources of variation. Also, PAP changed (P < 0.05) across the 5 time periods (i.e., increased with altitude and then declined as bulls returned to moderate altitude). Yearling PAP measurements collected at 1,525 m were highly correlated with PAP measures at 2,470 m, as well as a PAP collected at 18.3 ± 0.1 mo of age at 1,525 m (r = 0.93 to 0.99); therefore, suggesting that the yearling PAP measurement collected at 1,525 m in gain-tested bulls was an adequate predictor of PAP at elevations of 1,525 and 2,470 m as bulls aged to 18 months; however, additional study of bovine PAP across elevations, ages, and rates of gain is warranted.

© 2017 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. Earlier detection of colorectal cancer greatly improves prognosis, largely through surgical excision of neoplastic polyps. These include benign adenomas which can transform over time to malignant adenocarcinomas. This progression may be associated with changes in full blood count indices. An existing risk algorithm derived in Israel stratifies individuals according to colorectal cancer risk using full blood count data, but has not been validated in the UK. We undertook a retrospective analysis using the Clinical Practice Research Datalink. Patients aged over 40 with full blood count data were risk-stratified and followed up for a diagnosis of colorectal cancer over a range of time intervals. The primary outcome was the area under the receiver operating characteristic curve for the 18–24-month interval. We also undertook a case–control analysis (matching for age, sex, and year of risk score), and a cohort study of patients undergoing full blood count testing during 2012, to estimate predictive values. We included 2,550,119 patients. The area under the curve for the 18–24-month interval was 0.776 [95% confidence interval (CI): 0.771, 0.781]. Performance improves as the time interval reduces. The area under the curve for the age-matched case–control analysis was 0.583 [0.574, 0.591]. For the population risk-scored in 2012, the positive predictive value at 99.5% specificity was 8.8% with negative predictive value 99.6%. The algorithm offers an additional means of identifying risk of colorectal cancer, and could support other approaches to early detection, including screening and active case finding.

BackgroundOral anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF), but are underused. AURAS-AF (AUtomated Risk Assessment for Stroke in AF) is a software tool designed to identify eligible patients and promote discussions within consultations about initiating anticoagulants.AimTo investigate the implementation of the software in UK general practice.Design and settingProcess evaluation involving 23 practices randomly allocated to use AURAS-AF during a cluster randomised trial.MethodAn initial invitation to discuss anticoagulation was followed by screen reminders appearing during consultations until a decision had been made. The reminders required responses, giving reasons for cases where an anticoagulant was not initiated. Qualitative interviews with clinicians and patients explored acceptability and usability.ResultsIn a sample of 476 patients eligible for the invitation letter, only 159 (33.4%) were considered suitable for invitation by their GPs. Reasons given were frequently based on frailty, and risk of falls or haemorrhage. Of those invited, 35 (22%) started an anticoagulant (7.4% of those originally identified). A total of 1695 main-screen reminders occurred in 940 patients. In 883 instances, the decision was taken not to initiate and a range of reasons offered. Interviews with 15 patients and seven clinicians indicated that the intervention was acceptable, though the issue of disruptive screen reminders was raised.ConclusionAutomated risk assessment for stroke in atrial fibrillation and prompting during consultations are feasible and generally acceptable, but did not overcome concerns about frailty and risk of haemorrhage as barriers to anticoagulant uptake.

Background Shoulder dislocations are the most common joint dislocations seen in emergency departments. Most traumatic cases are anterior and cause recurrent dislocations. Management options include surgical and conservative treatments. There is a lack of evidence about which method is most effective after the first traumatic anterior shoulder dislocation (TASD). Objectives To produce UK age- and sex-specific incidence rates for TASD. To assess whether or not surgery within 6 months of a first-time TASD decreases re-dislocation rates compared with no surgery. To identify clinical predictors of recurrent dislocation. Design A population-based cohort study of first-time TASD patients in the UK. An initial validation study and subsequent propensity-score-matched analysis to compare re-dislocation rates between surgery and no surgery after a first-time TASD. Prediction modelling was used to identify potential predictors of recurrent dislocation. Setting UK primary and secondary care data. Participants Patients with a first-time TASD between 1997 and 2015. Interventions Stabilisation surgery within 6 months of a first-time TASD (compared with no surgery). Stabilisation surgery within 12 months of a first-time TASD was also carried out as a sensitivity analysis. Main outcome measure Re-dislocation rate up to 2 years after the first TASD. Methods Eligible patients were identified from the Clinical Practice Research Datalink (CPRD) (1997–2015). Accuracy of shoulder dislocation coding was internally validated using the CPRD General Practitioner questionnaire service. UK age- and sex-specific incidence rates for TASD were externally validated against rates from the USA and Canada. A propensity-score-matched analysis using linked CPRD and Hospital Episode Statistics (HES) data compared re-dislocation rates for patients aged 16–35 years, comparing surgery with no surgery. Multivariable Cox regression models for predicting re-dislocation were developed for the surgical and non-surgical cohorts. Results Shoulder dislocation was coded correctly for 89% of cases in the CPRD [95% confidence interval (CI) 83% to 95%], with a ‘primary’ dislocation confirmed for 76% of cases (95% CI 67% to 85%). Far fewer patients than expected received stabilisation surgery within 6 months of a first TASD, leading to an underpowered study. Around 20% of re-dislocation rates were observed for both surgical and non-surgical patients. The sensitivity analysis at 12 months also showed little difference in re-dislocation rates. Missing data on risk factors limited the value of the prediction modelling; however, younger age, epilepsy and sex (male) were identified as statistically significant predictors of re-dislocation. Limitations Far fewer than the expected number of patients had surgery after a first-time TASD, resulting in an underpowered study. This and residual confounding from missing risk factors mean that it is not possible to draw valid conclusions. Conclusions This study provides, for the first time, UK data on the age- and sex-specific incidence rates for TASD. Most TASD occurs in men, but an unexpected increased incidence was observed in women aged > 50 years. Surgery after a first-time TASD is uncommon in the NHS. Re-dislocation rates for patients receiving surgery after their first TASD are higher than previously expected; however, important residual confounding risk factors were not recorded in NHS primary and secondary care databases, thus preventing useful recommendations. Future work The high incidence of TASD justifies investigation into preventative measures for young men participating in contact sports, as well as investigating the risk factors in women aged > 50 years. A randomised controlled trial would account for key confounders missing from CPRD and HES data. A national TASD registry would allow for a more relevant data capture for this patient group. Study registration Independent Scientific Advisory Committee (ISAC) for the Medicines and Healthcare Products Regulatory Agency (ISAC protocol 15_0260). Funding The National Institute for Health Research Health Technology Assessment programme.

Background The ESTEEM trial was a cluster randomised controlled trial that compared two telephone triage management systems (general practitioner (GP) or a nurse supported by computer decision support software) with usual care, in response to a request for same-day consultation in general practice. Aim To investigate associations between trial patients’ demographic, health, and lifestyle characteristics, and their reported experiences of care. Setting Recruitment of 20 990 patients occurred between May 2011 and December 2012 in 42 GP practices in England (13 GP triage, 15 nurse triage, 14 usual care). Method Patients reported their experiences via a postal questionnaire issued 4 weeks after their initial request for a same-day consultation. Overall satisfaction, ease of accessing medical help/advice, and convenience of care were analysed using linear hierarchical modelling. Results Questionnaires were returned by 12 132 patients (58%). Older patients reported increased overall satisfaction compared with patients aged 25–59 years, but patients aged 16–24 years reported lower satisfaction. Compared with white patients, patients from ethnic minorities reported lower satisfaction in all three arms, although to a lesser degree in the GP triage arm. Patients from ethnic minorities reported higher satisfaction in the GP triage than in usual care, whereas white patients reported higher satisfaction with usual care. Patients unable to take time away from work or who could only do so with difficulty reported lower satisfaction across all three trial arms. Conclusions Patient characteristics, such as age, ethnicity and ability to attend their practice during work hours, were associated with their experiences of care following a same-day consultation request in general practice. Telephone triage did not increase satisfaction among patients who were unable to attend their practice during working hours. Trial registration number ISCRTN20687662.

ObjectivesConsultation duration has previously been shown to be associated with patient, practitioner and practice characteristics. However, previous studies were conducted outside the UK, considered only small numbers of general practitioner (GP) consultations or focused primarily on practitioner-level characteristics. We aimed to determine the patient-level and practice-level factors associated with duration of GP and nurse consultations in UK primary care.Design and settingCross-sectional data were obtained from English general practices contributing to the Clinical Practice Research Datalink (CPRD) linked to data on patient deprivation and practice staffing, rurality and Quality and Outcomes Framework (QOF) achievement.Participants218 304 patients, from 316 English general practices, consulting from 1 April 2013 to 31 March 2014.AnalysisMultilevel mixed-effects models described the association between consultation duration and patient-level and practice-level factors (patient age, gender, smoking status, ethnic group, deprivation and practice rurality, number of full-time equivalent GPs/nurses, list size, consultation rate, quintile of overall QOF achievement and training status).ResultsMean duration of face-to-face GP consultations was 9.24 min and 5.32 min for telephone consultations. Nurse face-to-face and telephone consultations lasted 9.70 and 5.73 min on average, respectively. Longer GP consultation duration was associated with female patient gender, practice training status and older patient age. Shorter duration was associated with higher deprivation and consultation rate. Longer nurse consultation duration was associated with male patient gender, older patient age and ever smoking; and shorter duration with higher consultation rate. Observed differences in duration were small (eg, GP consultations with female patients compared with male patients were 8 s longer on average).ConclusionsSmall observed differences in consultation duration indicate that patients are treated similarly regardless of background. Increased consultation duration may be beneficial for older or comorbid patients, but the benefits and costs of increased consultation duration require further study.

© 2017 Herrington et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Background It is uncertain whether being overweight, but not obese, is associated with advanced chronic kidney disease (CKD) and how the size and shape of associations between body-mass index (BMI) and advanced CKD differs among different types of people. Methods We used Clinical Practice Research Datalink records (2000-2014) with linkage to English secondary care and mortality data to identify a prospective cohort with at least one BMI measure. Cox models adjusted for age, sex, smoking and social deprivation and subgroup analyses by diabetes, hypertension and prior cardiovascular disease assessed relationships between BMI and CKD stages 4-5 and end-stage renal disease (ESRD). Findings 1,405,016 adults aged 20-79 with mean BMI 27.4kg/m2 (SD 5.6) were followed for 7.5 years. Compared to a BMI of 20 to

Stacey J Ackerman,1 David W Polly Jr,2 Tyler Knight,3 Karen Schneider,4 Tim Holt,5 John Cummings Jr6 1Covance Market Access Services Inc., San Diego, CA, USA; 2University of Minnesota, Orthopaedic Surgery, Minneapolis, MN, USA; 3Covance Market Access Services Inc., Gaithersburg, MD, USA; 4Covance Market Access Services Inc., Sydney, Australia; 5Montgomery Spine Center, Orthopedic Surgery, Montgomery, AL, USA; 6Community Health Network, Neurosurgery, Indianapolis, IN, USA Introduction: Low back pain is common and treatment costly with substantial lost productivity and lost wages in the working-age population. Chronic low back pain originating in the sacroiliac (SI) joint (15%–30% of cases) is commonly treated with nonoperative care, but new minimally invasive surgery (MIS) options are also effective in treating SI joint disruption. We assessed whether the higher initial MIS SI joint fusion procedure costs were offset by decreased nonoperative care costs from a US commercial payer perspective. Methods: An economic model compared the costs of treating SI joint disruption with either MIS SI joint fusion or continued nonoperative care. Nonoperative care costs (diagnostic testing, treatment, follow-up, and retail pharmacy pain medication) were from a retrospective study of Truven Health MarketScan® data. MIS fusion costs were based on the Premier's Perspective™ Comparative Database and professional fees on 2012 Medicare payment for Current Procedural Terminology code 27280. Results: The cumulative 3-year (base-case analysis) and 5-year (sensitivity analysis) differentials in commercial insurance payments (cost of nonoperative care minus cost of MIS) were $14,545 and $6,137 per patient, respectively (2012 US dollars). Cost neutrality was achieved at 6 years; MIS costs accrued largely in year 1 whereas nonoperative care costs accrued over time with 92% of up front MIS procedure costs offset by year 5. For patients with lumbar spinal fusion, cost neutrality was achieved in year 1. Conclusion: Cost offsets from new interventions for chronic conditions such as MIS SI joint fusion accrue over time. Higher initial procedure costs for MIS were largely offset by decreased nonoperative care costs over a 5-year time horizon. Optimizing effective resource use in both nonoperative and operative patients will facilitate cost-effective health care delivery. The impact of SI joint disruption on direct and indirect costs to commercial insurers, health plan beneficiaries, and employers warrants further consideration. Keywords: epidural injection, iFuse, economic model, sacroiliac joint fusion, sacroiliac joint pain, insurance

BACKGROUND: Electronic diabetes registers promote structured care and enable identification of undiagnosed diabetes, but they require consistent coding of the diagnosis in electronic medical records. We investigated the potential of electronic medical records to identify undiagnosed diabetes and to support diabetes management in a large primary care population in the United States. METHODS: We conducted a cross-sectional study and retrospective observational cohort analysis of primary care electronic medical records from a nationally representative US database (GE Centricity). We tested the feasibility of identifying patients with undiagnosed diabetes by applying simple algorithms to the electronic medical record data. We compared the quality of care provided to patients in the United States who had diabetes (coded and uncoded) for at least 15 months with the quality of care provided in England using a set of 16 indicators. RESULTS: We included 11 540 454 electronic medical records from more than 9000 primary care clinics across the United States. Of the 1 110 398 records indicating diagnosed diabetes, only 61.9% contained a diagnostic code. Of the 10 430 056 records for nondiabetic patients, 0.4% (n = 40 359) had at least 2 abnormal fasting or random blood glucose values, and 0.2% (n = 23 261) of the remaining records had at least 1 documented glycated hemoglobin (HbA1c) value of 6.5% or higher. Among the 622 260 patients for whom information on quality-of-care indicators was available, those with a coded diagnosis of diabetes had a significantly higher level of quality of care than those with uncoded diabetes (p < 0.01); however, the quality of care was generally lower than that indicated in England. INTERPRETATION: We were able to identify a substantial number of patients with uncoded diabetes and probable undiagnosed diabetes using simple algorithms applied to the primary care electronic records. Electronic coding of the diagnosis was associated with improved quality of care. Electronic diabetes registers are underused in US primary care and provide opportunities to facilitate the systematic, structured approach that is established in England.

BACKGROUND: Oral anticoagulants substantially reduce the risk of stroke in atrial fibrillation but are underutilised in current practice. AIM: To measure the distribution of stroke risk in patients with atrial fibrillation (using the CHADS(2) and CHA(2)DS(2)-VASc scores) and changes in oral anticoagulant use during 2007-2010. DESIGN AND SETTING: Longitudinal series of cross-sectional survey in 583 UK practices linked to the QResearch(®) database providing 99 351 anonymised electronic records from people with atrial fibrillation. METHOD: The proportion of patients in each CHADS(2) and CHA(2)DS(2)-VASc risk band in 2010 was calculated; for each of the years 2007-2010, the proportions with risk scores ≥2 that were using anticoagulants or antiplatelet agents were estimated. The proportions identified at high risk were re-estimated using alternative definitions of hypertension based on coded data. Finally, the prevalence of comorbid conditions in treated and untreated high-risk (CHADS(2) ≥2) groups was derived. RESULTS: The proportion at high risk of stroke in 2010 was 56.9% according to the CHADS(2) ≥2 threshold, and 84.5% according to CHA(2)DS(2)-VASc ≥2 threshold. The proportions of these groups receiving anticoagulants were 53.0% and 50.7% respectively and increased during 2007-2010. The means of identifying the population of individuals with hypertension significantly influenced the estimated proportion at high risk. Comorbid conditions associated with avoidance of anticoagulants included history of falls, use of nonsteroidal anti-inflammatory drugs, and dementia. CONCLUSION: Oral anticoagulant use in atrial fibrillation has increased in UK practice since 2007, but remains suboptimal. Improved coding of hypertension is required to support systematic identification of individuals at high risk of stroke and could be assisted by practice-based software.

John Paley’s article is good teaching material because it illustrates some classic rhetorical moves used in the ancient sport of argumentation. These include the ‘post hoc ergo propter hoc’ fallacy (assuming that if B occurred after A then A must have caused B); the ‘slippery slope’ fallacy (suggesting that the opponent is guilty of A, then taking the audience through a series of small steps in which A becomes B, B becomes C etc, and concluding that the opponent is guilty of Z); the ‘ad hominem’ fallacy (depicting the opponent as ignorant or foolish, and then concluding that everything s/he says is weak and superficial); and the ‘ad populum’ fallacy (appealing to some positive but ill-defined quality to which the audience is assumed to aspire – such as ‘rigour’ or ‘depth of understanding’). It is ironic, for example, that in the very first sentence of a paper which purports to explain complexity theory, Paley draws a direct and linear link between a series of introductory articles which we published back in 2001 and alleged misunderstandings and misapplications of complexity theory by others in the health care field. Paley claims that in our 2001 series, we ‘partially understood’ what he chose to define as the second principle of complexity – that ‘successive states of the system, globally defined, are determined by previous states, locally defined’. We apparently ‘failed to recognize’ what Paley decided was complexity theory’s first principle – that complexity is an explanatory concept. It is presumably coincidental, then, that Paley chose to use the same example (a termite colony) to illustrate this principle as we ourselves used to illustrate it in the first article in our series. Paley’s third principle of complexity is expressed thus: ‘Complexity explanations account for global order by specifying the local behaviour of units which have no awareness of the order thereby being produced, and which have no intention to produce it’. If, as he claims, we ‘failed to recognize’ this, why did we say in our first article ‘Order, innovation, and progress can emerge naturally from the interactions within a complex system; they do not need to be imposed centrally or from outside. For example, termite colonies construct the highest structures on the planet relative to the size of the builders. Yet there is no chief executive termite, no architect termite, and no blueprint. Each individual termite acts locally, seemingly following only a few simple shared rules of behaviour, within a context of other termites also acting locally. The termite mound emerges from a process of self organization’? Paley suggests that in our article on complexity, leadership and management, we misinterpreted the notion of the self-organizing system to mean that bottom-up approaches to organizational strategy and development should replace top-down ones. Had this been true, it would have been a grievous fault. What Plsek and Wilson actually said was ‘Complexity based organizational thinking suggests that goals and resources are established with a view towards the whole system, rather than artificially allocating them to parts of the system’. The article, written at a time when National Service Frameworks and other rigid, nationally imposed performance targets were stifling local initiative and flexibility, was arguing that tight central control can be counterproductive, not that organizations work better with nobody in charge. The analysis of an argument is incomplete without a consideration of the audience for which it was Trisha Greenhalgh MD, Professor of Primary Health Care, University College London, 206 Holborn Union Building, Highgate Hill, London N19 5LW, UK; Paul Plsek MSc, Independent consultant, Paul E. Plsek & Associates, Inc., Atlanta, USA; Tim Wilson FRCGP, Partner, PricewaterhouseCoopers, London, UK; Sarah Fraser DProf, Director, Sarah Fraser & Associates Ltd, Aylesbury, UK; Tim Holt FRCGP, Clinical Lecturer, University of Warwick, Coventry, UK.

BACKGROUND: Patients with atrial fibrillation (AF) are at significantly increased risk of stroke. Oral anticoagulants (OACs) substantially reduce this risk, with gains seen across the spectrum of baseline risk. Despite the benefit to patients, OAC prescribing remains suboptimal in the United Kingdom (UK). We will investigate whether an automated software system, operating within primary care electronic medical records, can improve the management of AF by identifying patients eligible for OAC therapy and increasing uptake of this treatment. METHODS/DESIGN: We will conduct a cluster randomised controlled trial, involving general practices using the Egton Medical Information Systems (EMIS) Web clinical system. We will randomise practices to use an electronic software tool or to continue with usual care. The tool will a) produce (and continually refresh) a list of patients with AF who are eligible for OAC therapy--practices will invite these patients to discuss therapy at the start of the trial--and b) generate electronic screen reminders in the medical records of those eligible, appearing throughout the trial. The software will run for 6 months in 23 intervention practices. A total of 23 control practices will manage their AF register in line with the usual care offered. The primary outcome is change in proportion of eligible patients with AF who have been prescribed OAC therapy after six months. Secondary outcomes are incidence of stroke, transient ischaemic attack, other major thromboembolism, major haemorrhage and reports of inappropriate OAC prescribing in the data collection sample--those deemed eligible for OACs. We will conduct a process evaluation in parallel with the randomised trial. We will use qualitative methods to examine patient and practitioner views of the intervention and its impact on primary care practice, including its time implications. DISCUSSION: AURAS-AF will investigate whether a simple intervention, using electronic primary care records, can improve OAC uptake in a high risk group for stroke. Given previous concerns about safety, especially surrounding inappropriate prescribing, we will also examine whether electronic reminders safely impact care in this clinical area. TRIAL REGISTRATION: http://ISRCTN 55722437.

BackgroundTelephone triage is proposed as a method of managing increasing demand for primary care. Previous studies have involved small samples in limited settings, and focused on nurse roles. Evidence is limited regarding the impact on primary care workload, costs, and patient safety and experience when triage is used to manage patients requesting same-day consultations in general practice.ObjectivesIn comparison with usual care (UC), to assess the impact of GP-led telephone triage (GPT) and nurse-led computer-supported telephone triage (NT) on primary care workload and cost, patient experience of care, and patient safety and health status for patients requesting same-day consultations in general practice.DesignPragmatic cluster randomised controlled trial, incorporating economic evaluation and qualitative process evaluation.SettingGeneral practices (n = 42) in four regions of England, UK (Devon, Bristol/Somerset, Warwickshire/Coventry, Norfolk/Suffolk).ParticipantsPatients requesting same-day consultations.InterventionsPractices were randomised to GPT, NT or UC. Data collection was not blinded; however, analysis was conducted by a statistician blinded to practice allocation.Main outcome measuresPrimary – primary care contacts [general practice, out-of-hours primary care, accident and emergency (A&E) and walk-in centre attendances] in the 28 days following the index consultation request. Secondary – resource use and costs, patient safety (deaths and emergency hospital admissions within 7 days of index request, and A&E attendance within 28 days), health status and experience of care.ResultsOf 20,990 eligible randomised patients (UCn = 7283; GPTn = 6695; NTn = 7012), primary outcome data were analysed for 16,211 patients (UCn = 5572; GPTn = 5171; NTn = 5468). Compared with UC, GPT and NT increased primary outcome contacts (over 28-day follow-up) by 33% [rate ratio (RR) 1.33, 95% confidence interval (CI) 1.30 to 1.36] and 48% (RR 1.48, 95% CI 1.44 to 1.52), respectively. Compared with GPT, NT was associated with a marginal increase in primary outcome contacts by 4% (RR 1.04, 95% CI 1.01 to 1.08). Triage was associated with a redistribution of primary care contacts. Although GPT, compared with UC, increased the rate of overall GP contacts (face to face and telephone) over the 28 days by 38% (RR 1.38, 95% CI 1.28 to 1.50), GP face-to-face contacts were reduced by 39% (RR 0.61, 95% CI 0.54 to 0.69). NT reduced the rate of overall GP contacts by 16% (RR 0.84, 95% CI 0.78 to 0.91) and GP face-to-face contacts by 20% (RR 0.80, 95% CI 0.71 to 0.90), whereas nurse contacts increased. The increased rate of primary care contacts in triage arms is largely attributable to increased telephone contacts. Estimated overall patient–clinician contact time on the index day increased in triage (GPT = 10.3 minutes; NT = 14.8 minutes; UC = 9.6 minutes), although patterns of clinician use varied between arms. Taking account of both the pattern and duration of primary outcome contacts, overall costs over the 28-day follow-up were similar in all three arms (approximately £75 per patient). Triage appeared safe, and no differences in patient health status were observed. NT was somewhat less acceptable to patients than GPT or UC. The process evaluation identified the complexity associated with introducing triage but found no consistency across practices about what works and what does not work when implementing it.ConclusionsIntroducing GPT or NT was associated with a redistribution of primary care workload for patients requesting same-day consultations, and at similar cost to UC. Although triage seemed to be safe, investigation of the circumstances of a larger number of deaths or admissions after triage might be warranted, and monitoring of these events is necessary as triage is implemented.Trial registrationCurrent Controlled Trials ISRCTN20687662.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 13. See the NIHR Journals Library website for further project information.

Background: Telephone triage is increasingly used to manage workload in primary care; however, supporting evidence for this approach is scarce. We aimed to assess the effectiveness and cost consequences of general practitioner-(GP)-led and nurse-led telephone triage compared with usual care for patients seeking same-day consultations in primary care. Methods: We did a pragmatic, cluster-randomised controlled trial and economic evaluation between March 1, 2011, and March 31, 2013, at 42 practices in four centres in the UK. Practices were randomly assigned (1:1:1), via a computer-generated randomisation sequence minimised for geographical location, practice deprivation, and practice list size, to either GP-led triage, nurse-led computer-supported triage, or usual care. We included patients who telephoned the practice seeking a same-day face-to-face consultation with a GP. Allocations were concealed from practices until after they had agreed to participate and a stochastic element was included within the minimisation algorithm to maintain concealment. Patients, clinicians, and researchers were not masked to allocation, but practice assignment was concealed from the trial statistician. The primary outcome was primary care workload (patient contacts, including those attending accident and emergency departments) in the 28 days after the first same-day request. Analyses were by intention to treat and per protocol. This trial was registered with the ISRCTN register, number ISRCTN20687662. Findings: We randomly assigned 42 practices to GP triage (n=13), nurse triage (n=15), or usual care (n=14), and 20 990 patients (n=6695 vs 7012 vs 7283) were randomly assigned, of whom 16 211 (77%) patients provided primary outcome data (n=5171 vs 5468 vs 5572). GP triage was associated with a 33% increase in the mean number of contacts per person over 28 days compared with usual care (2·65 [SD 1·74] vs 1·91 [1·43]; rate ratio [RR] 1·33, 95% CI 1·30-1·36), and nurse triage with a 48% increase (2·81 [SD 1·68]; RR 1·48, 95% CI 1·44-1·52). Eight patients died within 7 days of the index request: five in the GP-triage group, two in the nurse-triage group, and one in the usual-care group; however, these deaths were not associated with the trial group or procedures. Although triage interventions were associated with increased contacts, estimated costs over 28 days were similar between all three groups (roughly £75 per patient). Interpretation: Introduction of telephone triage delivered by a GP or nurse was associated with an increase in the number of primary care contacts in the 28 days after a patient's request for a same-day GP consultation, with similar costs to those of usual care. Telephone triage might be useful in aiding the delivery of primary care. The whole-system implications should be assessed when introduction of such a system is considered. Funding: Health Technology Assessment Programme UK National Institute for Health Research. © 2014 Campbell et al. Open Access article distributed under the terms of CC BY-NC-ND.

Continuous glucose monitoring is increasingly used in the management of diabetes. Subcutaneous glucose profiles are characterised by a strong non-stationarity, which limits the application of correlation-spectral analysis. We derived an index of linear predictability by calculating the autocorrelation function of time series increments and applied detrended fluctuation analysis to assess the non-stationarity of the profiles. Time series from volunteers with both type 1 and type 2 diabetes and from control subjects were analysed. The results suggest that in control subjects, blood glucose variation is relatively uncorrelated, and this variation could be modelled as a random walk with no retention of 'memory' of previous values. In diabetes, variation is both greater and smoother, with retention of inter-dependence between neighbouring values. Essential components for adequate longer term prediction were identified via a decomposition of time series into a slow trend and responses to external stimuli. Implications for diabetes management are discussed. © 2012 Elsevier Ireland Ltd.

Objectives: To synthesise current evidence for the effects of exenatide and liraglutide on heart rate, blood pressure and body weight.\ud \ud Design: Meta-analysis of available data from randomised controlled trials comparing Glucagon-like peptide-1 (GLP-1) analogues with placebo, active antidiabetic drug therapy or lifestyle intervention.\ud \ud Participants: Patients with type 2 diabetes.\ud \ud Outcome measures: Weighted mean differences between trial arms for changes in heart rate, blood pressure and body weight, after a minimum of 12-week follow-up.\ud \ud Results: 32 trials were included. Overall, GLP-1 agonists increased the heart rate by 1.86 beats/min (bpm) (95% CI 0.85 to 2.87) versus placebo and 1.90 bpm (1.30 to 2.50) versus active control. This effect was more evident for liraglutide and exenatide long-acting release than for exenatide twice daily. GLP-1 agonists decreased systolic blood pressure by −1.79 mm Hg (−2.94 to −0.64) and −2.39 mm Hg (−3.35 to −1.42) compared to placebo and active control, respectively. Reduction in diastolic blood pressure failed to reach statistical significance (−0.54 mm Hg (−1.15 to 0.07) vs placebo and −0.50 mm Hg (−1.24 to 0.24) vs active control). Body weight decreased by −3.31 kg (−4.05 to −2.57) compared to active control, but by only −1.22 kg (−1.51 to −0.93) compared to placebo.\ud \ud Conclusions: GLP-1 analogues are associated with a small increase in heart rate and modest reductions in body weight and blood pressure. Mechanisms underlying the rise in heart rate require further investigation.

BACKGROUND: Shoulder pain is a very common presentation in primary care. Evidence of benefit for subacromial corticosteroid injection is inconclusive and confined largely to studies with short follow-up. We plan a large, definitive, primary-care-based trial to determine efficacy and safety in patients with rotator cuff tendinopathy, and conducted a pilot trial to explore feasibility. METHODS: Six general practitioners (GPs) from Oxfordshire, UK underwent update training in assessing painful shoulders and injecting the subacromial space. Each then recruited patients aged 35 to 74 years from primary care complaining of shoulder pain lasting no more than 6 months. Eligible participants were randomized to receive either methylprednisolone acetate 40 mg with lidocaine 1% (total volume 1 ml), or lidocaine 1% alone (total volume 1 ml), injected into the subacromial space. The participants were blinded to treatment allocation. Feasibility outcomes were rates of recruitment, withdrawal, adherence to the protocol, completeness of follow-up, and success of patient masking. Clinical outcomes were the Oxford Shoulder Score (OSS) at baseline and at 4 and 12 weeks, and responses to three satisfaction questions at 2, 4 and 12 weeks. Outcome data were collected by postal questionnaires. RESULTS: A total of 40 participants were randomized (80% of the target 50 participants) over 26 weeks giving an overall recruitment rate of 1.5 participants per week. Rates of follow-up were maintained to a high level for the full 12 weeks. Four participants requested a 'rescue' corticosteroid injection but no patients withdrew. The trial GPs gave high scores for their confidence that the patient had remained blinded to treatment allocation during the procedure. The OSS at 4 and 12 weeks and the responses to the satisfaction questions are reported. CONCLUSIONS: It is feasible to recruit participants with shoulder pain in the primary care setting for a blinded, randomized trial of corticosteroid injection. Online randomization of participants from the practice is also feasible, and postal questionnaires provide an effective means of gathering outcome data in this area of study. The lessons learned from this pilot will usefully inform the design of a large, definitive efficacy trial in primary care. TRIAL REGISTRATION: Current Clinical Trials ISRCTN82357435.

Background Recent years have seen an increase in primary care workload, especially following the introduction of a new General Medical Services contract in 2004. Telephone triage and telephone consultation with patients seeking health care represent initiatives aimed at improving access to care. Some evidence suggests that such approaches may be feasible but conclusions regarding GP workload, cost, and patients’ experience of care, safety, and health status are equivocal. The ESTEEM trial aims to assess the clinical- and cost-effectiveness of nurse-led computer-supported telephone triage and GP-led telephone triage, compared to usual care, for patients requesting same-day consultations in general practice. Methods/design ESTEEM is a pragmatic, multi-centre cluster randomised clinical trial with patients randomised at practice level to usual care, computer decision-supported nurse triage, or GP-led triage. Following triage of 350–550 patients per practice we anticipate estimating and comparing total primary care workload (volume and time), the economic cost to the NHS, and patient experience of care, safety, and health status in the 4-week period following the index same-day consultation request across the three trial conditions. We will recruit all patients seeking a non-emergency same-day appointment in primary care. Patients aged 12.0–15.9 years and temporary residents will be excluded from the study. The primary outcome is the number of healthcare contacts taking place in the 4-week period following (and including) the index same-day consultation request. A range of secondary outcomes will be examined including patient flow, primary care NHS resource use, patients’ experience of care, safety, and health status. The estimated sample size required is 3,751 patients (11,253 total) in each of the three trial conditions, to detect a mean difference of 0.36 consultations per patient in the four week follow-up period between either intervention group and usual care 90% power, 5% alpha, and an estimated intracluster correlation coefficient ICC of 0.05. The primary analysis will be based on the intention-to-treat principle and take the form of a random effects regression analysis taking account of the hierarchical nature of the study design. Statistical models will allow for adjustment for practice level minimisation variables and patient-level baseline covariates shown to differ at baseline. Trial registration Current Controlled Trials ISCRTN20687662

OBJECTIVE: To synthesise current evidence for the influence on clinical behaviour of patient-specific electronically generated reminders available at the time of the clinical encounter. DATA SOURCES: PubMed, Cochrane library of systematic reviews; Science Citation Index Expanded; Social Sciences Citation Index; ASSIA; EMBASE; CINAHL; DARE; HMIC were searched for relevant articles. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS: We included controlled trials of reminder interventions if the intervention was: directed at clinician behaviour; available during the clinical encounter; computer generated (including computer generated paper-based reminders); and generated by patient-specific (rather than condition specific or drug specific) data. STUDY APPRAISAL AND SYNTHESIS METHODS: Systematic review and meta-analysis of controlled trials published since 1970. A random effects model was used to derive a pooled odds ratio for adherence to recommended care or achievement of target outcome. Subgroups were examined based on area of care and study design. Odds ratios were derived for each sub-group. We examined the designs, settings and other features of reminders looking for factors associated with a consistent effect. RESULTS: Altogether, 42 papers met the inclusion criteria. The studies were of variable quality and some were affected by unit of analysis errors due to a failure to account for clustering. An overall odds ratio of 1.79 [95% confidence interval 1.56, 2.05] in favour of reminders was derived. Heterogeneity was high and factors predicting effect size were difficult to identify. LIMITATIONS: Methodological diversity added to statistical heterogeneity as an obstacle to meta-analysis. The quality of included studies was variable and in some reports procedural details were lacking. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: The analysis suggests a moderate effect of electronically generated, individually tailored reminders on clinician behaviour during the clinical encounter. Future research should concentrate on identifying the features of reminder interventions most likely to result in the target behaviour. © Society of General Internal Medicine 2012.

An estimated 750,000 people in the UK have diabetes that is either undiagnosed or unrecorded on diabetes registers. Opportunities are missed to prevent or delay complications and reduce cardiovascular risk. This 'missing population' problem has been addressed at various levels raising awareness among the public; targeted case finding in at-risk groups; and lowering the threshold for investigation of suggestive symptoms among clinicians. Cardiovascular risk assessments are recommended in the UK for the over 40-year-old population and include blood glucose measurements. To further support these measures, this article discusses a recently reported technique for identifying possible cases of undiagnosed diabetes using simple searches on primary care databases, and its implications for practice and future research. © SAGE Publications 2008 Los Angeles, London, New Delhi and Singapore.

The NHS Care Records Service (CRS) is a major goal of the National Health Service (NHS) Modernisation Programme. It will provide for 24-hour access by clinicians to electronic patient records and the integration of information from previously separate databases, reducing the 'seams' between primary and secondary care, between out-of-hours and ordinary working hours, and ultimately between health and social care. Such integration is likely to affect not only individual patient care, but also public health including disease surveillance, and the monitoring of clinical activities including the achievement of clinical governance targets. The potential benefits for patients, practitioners and managers are numerous. However, the process raises issues over confidentiality, data protection and data quality. During 2003 a project was undertaken in South Warwickshire to develop an NHS CRS widely available to primary care clinicians in the region. This was part of a wider initiative funded by the NHS Connecting for Health (NHS CfH). Twenty-six out of 36 local practices took part, providing a combined database of 181 961 clinical records. All but one of the original objectives was achieved. Lessons were learned which could usefully inform the development of the CRS more generally in the NHS.

BACKGROUND: Interventions promoting physical activity by General Practitioners (GPs) lack a strong evidence base. Recruiting participants to trials in primary care is challenging. We investigated the feasibility of (i) delivering three interventions to promote physical activity in inactive participants and (ii) different methods of participant recruitment and randomised allocation. METHODS: We recruited general practices from Devon, Bristol and Coventry. We used a 2-by-2 factorial design for participant recruitment and randomisation. Recruitment strategies were either opportunistic (approaching patients attending their GP surgery) or systematic (selecting patients from practice lists and approaching them by letter). Randomisation strategies were either individual or by practice cluster. Feasibility outcomes included time taken to recruit the target number of participants within each practice. Participants were randomly allocated to one of three interventions: (i) written advice (control); (ii) brief GP advice (written advice plus GP advice on physical activity), and (iii) brief GP advice plus a pedometer to self-monitor physical activity during the trial. Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity, and were instructed not to unseal the pedometer before the scheduled day of data collection. Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period, and European Quality of Life (EuroQoL)-5 dimensions (EQ-5D) scores, recorded at 12 weeks' follow-up. RESULTS: We recruited 24 practices (12 using each recruitment method; 18 randomising by cluster, 6 randomising by individual participant), encompassing 131 participants. Opportunistic recruitment was associated with less time to target recruitment compared with systematic (mean difference (days) -54.9, 95% confidence interval (CI) -103.6; -6.2) but with greater loss to follow up (28.8% versus. 6.9%; mean difference 21.9% (95% CI 9.6%; 34.1%)). There were differences in the socio-demographic characteristics of participants according to recruitment method. There was no clear pattern of change in participant level outcomes from baseline to 12 weeks across the three arms. CONCLUSIONS: Delivering and trialling GP-led interventions to promote physical activity is feasible, but trial design influences time to participant recruitment, participant withdrawal, and possibly, the socio-demographic characteristics of participants. TRIAL REGISTRATION NUMBER: ISRCTN73725618.

BACKGROUND: Primary care is the main source of health care in many health systems, including the UK National Health Service (NHS), but few objective data exist for the volume and nature of primary care activity. With rising concerns that NHS primary care workload has increased substantially, we aimed to assess the direct clinical workload of general practitioners (GPs) and practice nurses in primary care in the UK.METHODS: We did a retrospective analysis of GP and nurse consultations of non-temporary patients registered at 398 English general practices between April, 2007, and March, 2014. We used data from electronic health records routinely entered in the Clinical Practice Research Datalink, and linked CPRD data to national datasets. Trends in age-standardised and sex-standardised consultation rates were modelled with joinpoint regression analysis.FINDINGS: The dataset comprised 101 818 352 consultations and 20 626 297 person-years of observation. The crude annual consultation rate per person increased by 10·51%, from 4·67 in 2007-08, to 5·16 in 2013-14. Consultation rates were highest in infants (age 0-4 years) and elderly people (≥85 years), and were higher for female patients than for male patients of all ages. The greatest increases in age-standardised and sex-standardised rates were in GPs, with a rise of 12·36% per 10 000 person-years, compared with 0·9% for practice nurses. GP telephone consultation rates doubled, compared with a 5·20% rise in surgery consultations, which accounted for 90% of all consultations. The mean duration of GP surgery consultations increased by 6·7%, from 8·65 min (95% CI 8·64-8·65) to 9·22 min (9·22-9·23), and overall workload increased by 16%.INTERPRETATION: Our findings show a substantial increase in practice consultation rates, average consultation duration, and total patient-facing clinical workload in English general practice. These results suggest that English primary care as currently delivered could be reaching saturation point. Notably, our data only explore direct clinical workload and not indirect activities and professional duties, which have probably also increased. This and additional research questions, including the outcomes of workload changes on other sectors of health care, need urgent answers for primary care provision internationally.FUNDING: Department of Health Policy Research Programme.