Sodium-glucose co-transporter-2 inhibitor cardiovascular outcome trials and generalizability to English primary care.

AIM: To identify people in English primary care with equivalent cardiovascular risk to participants in the sodium-glucose co-transporter-2 inhibitor (SGLT-2i) cardiovascular outcome trials (CVOTs). A secondary objective was to report the usage of SGLT-2is. METHODS: Cross-sectional analysis of people registered with participating practices in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network on the 31 December 2016. We derived: (1) proportions of the primary care population eligible for inclusion in each SGLT-2i CVOT (CANVAS, DECLARE, EMPA-REG and VERTIS); (2) characteristics of the eligible population compared with trial participants (demographics, disease duration and vascular risk); and (3) differences within the eligible population prescribed SGLT-2is. RESULTS: The proportions of people with type 2 diabetes (N = 84 394) meeting the inclusion criteria for each CVOT were: DECLARE 27% [95% confidence interval (CI) 26.5-27.1]; CANVAS 17% (16.6-17.1); VERTIS 7% (7.1-7.4); and EMPA-REG 7% (6.5-6.8). Primary care populations fulfilling inclusion criteria were 5-8 years older than trial cohorts, and <10% with inclusion criteria of each trial were prescribed an SGLT-2i; a greater proportion were men, and of white ethnicity. CONCLUSIONS: There was variation in proportions of the primary care type 2 diabetes population fulfilling inclusion criteria of SGLT-2i CVOTs. The more stringent the inclusion criteria, the lower the proportion identified in a primary care setting. Prescription rates for SGLT-2is were low in this national database, and there were demographic disparities in prescribing.

Obstructive sleep apnoea in Type 2 diabetes mellitus: increased risk for overweight as well as obese people included in a national primary care database analysis.

AIMS: To determine obstructive sleep apnoea prevalence in people with Type 2 or Type 1 diabetes in a national primary care setting, stratified by BMI category, and to explore the relationship between patient characteristics and obstructive sleep apnoea. METHODS: Using the Royal College of General Practitioners Research and Surveillance Centre database, a cross-sectional analysis was conducted. Diabetes type was identified using a seven-step algorithm and was grouped by Type 2 diabetes, Type 1 diabetes and no diabetes. The clinical characteristics of these groups were analysed, BMI-stratified obstructive sleep apnoea prevalence rates were calculated, and a multilevel logistic regression analysis was completed on the Type 2 diabetes group. RESULTS: Analysis of 1 275 461 adult records in the Royal College of General Practitioners Research and Surveillance Centre network showed that obstructive sleep apnoea was prevalent in 0.7%. In people with Type 2 diabetes, obstructive sleep apnoea prevalence increased with each increasing BMI category, from 0.5% in those of normal weight to 9.6% in those in the highest obesity class. By comparison, obstructive sleep apnoea prevalence rates for these BMI categories in Type 1 diabetes were 0.3% and 4.3%, and in those without diabetes 1.2% and 3.9%, respectively. Obstructive sleep apnoea was more prevalent in men than women in both diabetes types. When known risk factors were adjusted for, there were increased odds ratios for obstructive sleep apnoea in people with Type 2 diabetes in the overweight and higher BMI categories. CONCLUSIONS: Obstructive sleep apnoea was reported in people with both types of diabetes across the range of overweight categories and not simply in the highest obesity class.

Measuring Quality of Healthcare Outcomes in Type 2 Diabetes from Routine Data: a Seven-nation Survey Conducted by the IMIA Primary Health Care Working Group.

Background: The Institute of Medicine framework defines six dimensions of quality for healthcare systems: (1) safety, (2) effectiveness, (3) patient centeredness, (4) timeliness of care, (5) efficiency, and (6) equity. Large health datasets provide an opportunity to assess quality in these areas. Objective: To perform an international comparison of the measurability of the delivery of these aims, in people with type 2 diabetes mellitus (T2DM) from large datasets. Method: We conducted a survey to assess healthcare outcomes data quality of existing databases and disseminated this through professional networks. We examined the data sources used to collect the data, frequency of data uploads, and data types used for identifying people with T2DM. We compared data completeness across the six areas of healthcare quality, using selected measures pertinent to T2DM management. Results: We received 14 responses from seven countries (Australia, Canada, Italy, the Netherlands, Norway, Portugal, Turkey and the UK). Most databases reported frequent data uploads and would be capable of near real time analysis of healthcare quality.The majority of recorded data related to safety (particularly medication adverse events) and treatment efficacy (glycaemic control and microvascular disease). Data potentially measuring equity was less well recorded. Recording levels were lowest for patient-centred care, timeliness of care, and system efficiency, with the majority of databases containing no data in these areas. Databases using primary care sources had higher data quality across all areas measured. Conclusion: Data quality could be improved particularly in the areas of patient-centred care, timeliness, and efficiency. Primary care derived datasets may be most suited to healthcare quality assessment.

Glucose test provenance recording in UK primary care: was that fasted or random?

AIMS: To describe the proportion of glucose tests with unrecorded provenance in routine primary care data and identify the impact on clinical practice. METHODS: A cross-sectional analysis was conducted of blood glucose measurements from the Royal College of General Practitioner Research and Surveillance Centre database, which includes primary care records from >100 practices across England and Wales. All blood glucose results recorded during 2013 were identified. Tests were grouped by provenance (fasting, oral glucose tolerance test, random, none specified and other). A clinical audit in a single primary care practice was also performed to identify the impact of failing to record glucose provenance on diabetes diagnosis. RESULTS: A total of 2 137 098 people were included in the cross-sectional analysis. Of 203 350 recorded glucose measurements the majority (117 893; 58%) did not have any provenance information. The most commonly reported provenance was fasting glucose (75 044; 37%). The distribution of glucose values where provenance was not recorded was most similar to that of fasting samples. The glucose measurements of 256 people with diabetes in the audit practice (size 11 514 people) were analysed. The initial glucose measurement had no provenance information in 164 cases (64.1%). A clinician questioned the provenance of a result in 41 cases (16.0%); of these, 14 (34.1%) required repeating. Lack of provenance led to delays in the diagnosis of diabetes [median (range) 30 (3-614) days]. CONCLUSIONS: The recording of glucose provenance in UK primary care could be improved. Failure to record provenance causes unnecessary repeated testing, delayed diagnosis and wasted clinician time.

Association between glycaemic control and common infections in people with Type 2 diabetes: a cohort study.

AIM: To investigate the impact of glycaemic control on infection incidence in people with Type 2 diabetes. METHODS: We compared infection rates during 2014 in people with Type 2 diabetes and people without diabetes in a large primary care cohort in the UK (the Royal College of General Practitioners Research and Surveillance Centre database). We performed multilevel logistic regression to investigate the impact of Type 2 diabetes on presentation with infection, and the effect of glycaemic control on presentation with upper respiratory tract infections, bronchitis, influenza-like illness, pneumonia, intestinal infectious diseases, herpes simplex, skin and soft tissue infections, urinary tract infections, and genital and perineal infections. People with Type 2 diabetes were stratified by good [HbA1c < 53 mmol/mol (< 7%)], moderate [HbA1c 53-69 mmol/mol (7-8.5%)] and poor [HbA1c > 69 mmol/mol (> 8.5%)] glycaemic control using their most recent HbA1c concentration. Infection incidence was adjusted for important sociodemographic factors and patient comorbidities. RESULTS: We identified 34 278 people with Type 2 diabetes and 613 052 people without diabetes for comparison. The incidence of infections was higher in people with Type 2 diabetes for all infections except herpes simplex. Worsening glycaemic control was associated with increased incidence of bronchitis, pneumonia, skin and soft tissue infections, urinary tract infections, and genital and perineal infections, but not with upper respiratory tract infections, influenza-like illness, intestinal infectious diseases or herpes simplex. CONCLUSIONS: Almost all infections analysed were more common in people with Type 2 diabetes. Infections that are most commonly of bacterial, fungal or yeast origin were more frequent in people with worse glycaemic control.

Correlates of psychological care strategies for people with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study.

AIMS: To assess the ways in which healthcare professionals address psychological problems of adults with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study. METHODS: Approximately 120 primary care physicians, 80 diabetes specialists and 80 nurses and dietitians providing diabetes care participated in each of 17 countries (N=4785). Multiple regression analyses were used to evaluate independent statistically significant associations of respondent attributes concerning psychological care strategies, including assessment of diabetes impact on the patient's life, assessment of depression, provision of psychological assessment and support, and coordination with mental health professionals. RESULTS: Psychological care strategies were positively associated with each other but differed by healthcare practice site and discipline; nurses and dietitians were less likely to assess depression than other healthcare professionals, while primary care physicians were less likely to coordinate with mental health specialists or ask patients how diabetes affects their lives. Psychological care was positively associated with healthcare professionals' beliefs that patients need help dealing with emotional issues and that clinical success depends on doing so, and also with level of psychological care training, multidisciplinary team membership and availability of resources for psychological care. There were significant between-country variations in psychological care strategies, before and after adjustment for individual-level factors, and significant country-by-covariate interactions for almost all individual-level factors investigated. CONCLUSIONS: Improvements in training and resources, recognition and assessment of psychological problems, and increased belief in the efficacy of psychological support may enhance healthcare professionals' efforts to address psychological problems in adults with diabetes.

Incidence, worry and discussion about dosing irregularities and self-treated hypoglycaemia amongst HCPs and patients with type 2 diabetes: results from the UK cohort of the Global Attitudes of Patient and Physicians (GAPP2) survey.

AIMS: The Global Attitude of Patients and Physicians 2 (GAPP2) survey sought to address gaps in understanding about real-world basal insulin-taking behaviour and self-treated hypoglycaemia in patients with type 2 diabetes mellitus. MATERIALS AND METHODS: The Global Attitude of Patients and Physicians 2 was an international, online, cross-sectional study of patients aged at least 40 years with type 2 diabetes taking analogue insulins, and healthcare professionals (HCPs). Patients were recruited from general consumer online research panels, comprising a representative sample of the population to minimise bias. HCPs were recruited from online specialist research panels. The results of the UK cohort are presented here. RESULTS: The UK cohort constituted 12% of the total GAPP2 population. In this cohort, 15-25% of patients reported that they had reduced, missed or mistimed at least one dose of insulin in the previous month. On the last occasion that patients had reduced a dose, 82% had done so intentionally - most frequently because of concerns about hypoglycaemia. HCP estimates of the numbers of patients with dosing irregularities were nearly fourfold higher than patient reports. More than one-third of HCPs believe their patients under-report the frequency of self-treated hypoglycaemia. Nevertheless, a proportion did not regularly discuss these concerns with their patients. CONCLUSIONS: Healthcare professionals are in the best position to support patients in making appropriate insulin dose adjustments to help regularise blood glucose levels and reduce treatment-induced hypoglycaemic events. This can be achieved by initiating frequent discussions with all patients and providing education and training when appropriate.

Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national comparisons on barriers and resources for optimal care--healthcare professional perspective.

AIMS: The second Diabetes Attitudes, Wishes and Needs (DAWN2) study sought cross-national comparisons of perceptions on healthcare provision for benchmarking and sharing of clinical practices to improve diabetes care. METHODS: In total, 4785 healthcare professionals caring for people with diabetes across 17 countries participated in an online survey designed to assess diabetes healthcare provision, self-management and training. RESULTS: Between 61.4 and 92.9% of healthcare professionals felt that people with diabetes needed to improve various self-management activities; glucose monitoring (range, 29.3-92.1%) had the biggest country difference, with a between-country variance of 20%. The need for a major improvement in diabetes self-management education was reported by 60% (26.4-81.4%) of healthcare professionals, with a 12% between-country variance. Provision of diabetes services differed among countries, with many healthcare professionals indicating that major improvements were needed across a range of areas, including healthcare organization [30.6% (7.4-67.1%)], resources for diabetes prevention [78.8% (60.4-90.5%)], earlier diagnosis and treatment [67.9% (45.0-85.5%)], communication between team members and people with diabetes [56.1% (22.3-85.4%)], specialist nurse availability [63.8% (27.9-90.7%)] and psychological support [62.7% (40.6-79.6%)]. In some countries, up to one third of healthcare professionals reported not having received any formal diabetes training. Societal discrimination against people with diabetes was reported by 32.8% (11.4-79.6%) of participants. CONCLUSIONS: This survey has highlighted concerns of healthcare professionals relating to diabetes healthcare provision, self-management and training. Identifying between-country differences in several areas will allow benchmarking and sharing of clinical practices.

Scalp EEG-based discrimination of cognitive deficits after traumatic brain injury using event-related Tsallis entropy analysis.

Traumatic brain injury (TBI) is the leading cause of death and disability in children and adolescents in the U.S. This is a pilot study, which explores the discrimination of chronic TBI from normal controls using scalp EEG during a memory task. Tsallis entropies are computed for responses during an old-new memory recognition task. A support vector machine model is constructed to discriminate between normal and moderate/severe TBI individuals using Tsallis entropies as features. Numerical analyses of 30 records (15 normal and 15 TBI) show a maximum discrimination accuracy of 93% (p-value = 7.8557E-5) using four features. These results suggest the potential of scalp EEG as an efficacious method for noninvasive diagnosis of TBI.

Practical steps to improving the management of type 1 diabetes: recommendations from the Global Partnership for Effective Diabetes Management.

The Diabetes Control and Complications Trial (DCCT) led to considerable improvements in the management of type 1 diabetes, with the wider adoption of intensive insulin therapy to reduce the risk of complications. However, a large gap between evidence and practice remains, as recently shown by the Pittsburgh Epidemiology of Diabetes Complications (EDC) study, in which 30-year rates of microvascular complications in the 'real world' EDC patients were twice that of DCCT patients who received intensive insulin therapy. This gap may be attributed to the many challenges that patients and practitioners face in the day-to-day management of the disease. These barriers include reaching glycaemic goals, overcoming the reality and fear of hypoglycaemia, and appropriate insulin therapy and dose adjustment. As practitioners, the question remains: how do we help patients with type 1 diabetes manage glycaemia while overcoming barriers? In this article, the Global Partnership for Effective Diabetes Management provides practical recommendations to help improve the care of patients with type 1 diabetes.

A systematic review of the clinical effectiveness and cost-effectiveness and economic modelling of minimal incision total hip replacement approaches in the management of arthritic disease of the hip.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of minimal incision approaches to total hip replacement (THR) for arthritis of the hip. DATA SOURCES: Major electronic databases were searched from 1966 to 2007. Relevant websites were also examined and experts in the field were consulted. REVIEW METHODS: Studies of minimal (one or two) incision THR compared with standard THR were assessed for inclusion in the review of clinical effectiveness. A systematic review of economic evaluations comparing a minimal incision approach to standard THR was also performed and the estimates from the systematic review of clinical effectiveness were incorporated into an economic model. Utilities data were sourced to estimate quality-adjusted life-years (QALYs). Due to lack of data, no economic analysis was conducted for the two mini-incision surgical method. RESULTS: Nine randomised controlled trials (RCTs), 17 non-randomised comparative studies, six case series and one registry were found to be useful for the comparison of single mini-incision THR with standard THR. One RCT compared two mini-incision THR with standard THR, and two RCTs, five non-randomised comparative studies and two case series compared two mini-incision with single mini-incision THR. The RCTs were of moderate quality. Most had fewer than 200 patients and had a follow-up period of less than 1 year. The single mini-incision THR may have some perioperative advantages, e.g. blood loss [weighted mean difference (WMD) -57.71 ml, p<0.01] and shorter operative time, of uncertain practical significance. It may also offer a shorter recovery period and greater patient satisfaction. Evidence on long-term outcomes (especially revision) is too limited to be useful. Lack of data prevented subgroup analysis. With respect to the two-incision approach, data were suggestive of shorter recovery compared with single-incision THR, but conclusions must be treated with caution. The costs to the health service, per patient, of single mini-incision THR depend upon assumptions made, but are similar at one year (7060 pounds sterling vs 7350 pounds sterling for standard THR). For a 40-year time horizon the costs were 11,618 pounds sterling for mini-incision and 11,899 pounds sterling for standard THR. Two existing economic evaluations were identified, but they added little, if any, value to the current evidence base owing to their limited quality. In the economic model, mini-incision THR was less costly and provided slightly more QALYs in both the 1- and 40-year analyses. The mean QALYs at 1 year were 0.677 for standard THR and 0.695 for mini-incision THR. At 40 years, the mean QALYs were 8.463 for standard THR and 8.480 for mini-incision. At 1 year the probabilistic sensitivity analyses indicate that mini-incision THR has a 95% probability of being cost-effective if society's willingness to pay for a QALY were up to 50,000 pounds sterling. This is reduced to approximately 55% for the 40-year analysis. The results were driven by the assumption of a 1-month earlier return to usual activities and a decreased hospital length of stay and operation duration following mini-incision THR. If mini-incision THR actually required more intensive use of resources it would become approximately 200 pounds sterling more expensive and would only be cost-effective (cost per QALY>30,000 pounds sterling) if recovery was 1.5 weeks faster. A threshold analysis around risk of revision showed, using the same cost per QALY threshold, mini-incision THR would have to have no more than a 7.5% increase in revisions compared with standard THR for it to be no longer considered cost-effective (one more revision for every 200 procedures performed). Further sensitivity analysis involved relaxing assumptions of equal long-term outcomes where possible. and broadly similar results to the base-case analysis were found in this and further sensitivity analyses. CONCLUSIONS: Compared with standard THR, minimal incision THR has small perioperative advantages in terms of blood loss and operation time. It may offer a shorter hospital stay and quicker recovery. It appears to have a similar procedure cost to standard THR, but evidence on its longer term performance is very limited. Further long-term follow-up data on costs and outcomes including analysis of subgroups of interest to the NHS would strengthen the current economic evaluation.

Insulin for type 2 diabetes: choosing a second-line insulin regimen.

UNLABELLED: Guidance has been published on the choice of initial insulin regimen for patients with type 2 diabetes [NPH (isophane) insulin or a long-acting insulin analogue] but not on how to choose a second regimen when glycaemic control becomes unsatisfactory. AIMS: To develop pragmatic clinical guidance for choosing a second-line insulin regimen tailored to the individual needs of patients with type 2 diabetes after failure of first-line insulin therapy. METHODS: Formulation of a consensus by expert panel based on published evidence and best clinical practice, taking into account patient preferences, lifestyle and functional capacity. RESULTS: Six patient-dependent factors relevant to the choice of second-line insulin regimen and three alternative insulin regimens (twice-daily premixed, basal-plus and basal-bolus) were identified. The panel recommended one or more insulin regimens compatible with each factor, emphasising the fundamental importance of a healthy lifestyle that includes exercise and weight reduction. These recommendations were incorporated into an algorithm to provide pragmatic guidance for clinicians. CONCLUSION: The three alternative insulin regimens offer different benefits and drawbacks and it is important to make the right choice to optimise outcomes for patients.

Raising diabetes awareness in the public domain.

Type 2 diabetes mellitus (T2DM) is a chronic, debilitating and costly disease associated with severe complications, and has been recognised as such by the United Nations (UN). But despite being a leading cause of death and serious disability worldwide, the public often perceive T2DM as a relatively mild condition. Furthermore, many people do not know that T2DM is preventable and that steps can be taken to minimise the risk of developing the disease. Improved public awareness of T2DM and its link with obesity and physical inactivity is critical, not only to prevention but also management of diabetes. Recognising this need, the UN has issued a resolution calling on member states to observe World Diabetes Day and implement education and mass media initiatives to raise public awareness of diabetes and its complications. This article reviews selected local, national and international public awareness campaigns to illustrate the range of initiatives that together can work towards the goals of the UN Resolution. By building understanding of diabetes, changing beliefs and attitudes and promoting positive behaviours, such initiatives can help combat the global diabetes epidemic and improve the health and wellbeing of people.

Improving glucose management: ten steps to get more patients with type 2 diabetes to glycaemic goal. Recommendations from the Global Partnership for Effective Diabetes Management.

Despite increasingly stringent clinical practice guidelines for glycaemic control, the implementation of recommendations has been disappointing, with over 60% of patients not reaching recommended glycaemic goals. As a result, current management of glycaemia falls significantly short of accepted treatment goals. The Global Partnership for Effective Diabetes Management has identified a number of major barriers that can prevent individuals from achieving their glycaemic targets. This article proposes 10 key practical recommendations to aid healthcare providers in overcoming these barriers and to enable a greater proportion of patients to achieve glycaemic goals. These include advice on targeting the underlying pathophysiology of type 2 diabetes, treating early and effectively with combination therapies, adopting a holistic, multidisciplinary approach and improving patient understanding of type 2 diabetes. Implementation of these recommendations should reduce the risk of diabetes-related complications, improve patient quality of life and impact more effectively on the increasing healthcare cost related to diabetes.

Cystostomy button for bladder drainage in children.

PURPOSE: The "button" enteral feeding systems are widely used as a gastrostomy. We describe our use of this device to facilitate bladder drainage in children. MATERIALS AND METHODS: We prospectively reviewed all patients who underwent insertion of a cystostomy button between 2002 and 2005. Indications and complications were analyzed. RESULTS: A total of 17 children (8 female, 9 male) with a mean age of 7.1 years underwent insertion of a cystostomy button during the 4-year period. Mean followup was 16 months (range 2 to 40). Cases selected included those with a neuropathic bladder, prune belly syndrome, previous major bladder neck surgery and those unsuitable for Mitrofanoff stoma formation. Complications included 1 wound infection treated with antibiotics. Four children had leakage from the cystostomy site that was successfully treated with a change in button size, and 14 buttons remain in situ. CONCLUSIONS: Button cystostomy is a safe and effective form of bladder drainage in children. It is a good alternative to standard suprapubic drainage and it gives children an improved quality of life.