Improved implementation of medical tests - barriers and opportunities.

Applying the concept of a value proposition to medical testing is just one of the many ways to identify and monitor the value of tests. A key part of this concept focusses on processes that should take place after a test is introduced into routine local practice, namely test implementation. This process requires identification of the clinical pathway, the stakeholders and the benefits or disbenefits that accrue to those stakeholders. There are various barriers and challenges to test implementation. Implementation requires the process of clinical audit which involves measurement of outcomes external to the laboratory but this is not widely performed in laboratory medicine. A second key challenge is that implementation requires liaison with stakeholders outside of the laboratory including clinicians and other healthcare professional such as finance managers. Many laboratories are remote from clinical care and other stakeholders making such liaison difficult. The implementation process is based on data which again will be primarily on processes outside of the laboratory. However the recent enthusiasm for so-called real world data and new data mining techniques may represent opportunities that will facilitate better test implementation. A final barrier is that a range of new tools not currently in the education curriculum of the laboratory professional is required for implementation such as those of preparing a business case to support the introduction of a test and health economic analysis. The professional bodies in laboratory medicine could assist with education in these areas.

Estimating and examining the costs of inpatient diabetes care in an Irish Public Hospital.

AIM: To estimate and examine hospitalisation costs of Type 1 and Type 2 diabetes in an Irish public hospital. METHODS: A retrospective audit of hospital inpatient admissions over a 5-year period was undertaken, and a wide range of admission-related data were collected for a sample of 7,548 admissions. Hospitalisations were costed using the diagnosis-related group methodology. A series of descriptive, univariate and multivariate regression analyses were undertaken. RESULTS: The mean hospitalisation cost for Type 1 diabetes was €4,027 and for Type 2 diabetes was €5,026 per admission. Sex, admission type and length of stay were significantly associated with hospitalisation costs for admissions with a primary diagnosis of Type 1 diabetes. Age, admission type, diagnosis status, complications status, discharge destination, length of stay and year were significantly associated with hospitalisation costs for admissions with a primary diagnosis of Type 2 diabetes. Length of stay was associated with higher mean costs, with each additional day increasing Type 1 diabetes costs by €260 (p = 0.001) and Type 2 diabetes by €216 (p < 0.001). Unscheduled admissions were associated with significantly lower costs than elective admissions; €1,578 (p = 0.035) lower for Type 1 diabetes and €2,108 (p < 0.001) lower for Type 2 diabetes. CONCLUSIONS: This study presents estimates of the costs of diabetes care in the Irish public hospital system and identifies the factors which influence costs for Type 1 and Type 2 diabetes. These findings may be of interest to patients, the public, researchers and those with influence over diabetes policy and practice in Ireland and internationally.

Reduced kidney function is associated with poorer domain-specific cognitive performance in community-dwelling older adults.

OBJECTIVES: Whilst chronic kidney disease has been associated with cognitive impairment, the association between reduced estimated Glomerular Filtration Rate (eGFR) and domain-specific cognitive performance is less clear and may represent an important target for the promotion of optimal brain health in older adults. METHODS: Participants aged >60 years from the Trinity-Ulster-Department of Agriculture study underwent detailed cognitive assessment using the Mini-Mental State Examination (Mini-Mental State Examination (MMSE)), Frontal Assessment Battery (FAB) and Repeatable Battery for Assessment of Neuropsychological Status (RBANS). Poisson and linear regression models assessed the relationship between eGFR strata and cognitive performance. RESULTS: In 4887 older adults (73.9 ± 8.3 years; 67.7% female), declining eGFR strata was associated with greater likelihood of error on the MMSE/FAB and poorer overall performance on the RBANS. Following robust covariate adjustment, findings were greatest for GFR <45 ml/ml/1.73 m2 (Incidence Rate Ratio: 1.17; 95% CI 1.08, 1.27; p < 0.001 for MMSE; IRR: 1.13; 95% CI 1.04, 1.13; p < 0.001 for FAB; ß: -3.66; 95% CI -5.64, -1.86; p < 0.001 for RBANS). Additionally, eGFR <45 ml/ml/1.73 m2 was associated with poorer performance on all five RBANS domains, with greatest effect sizes for immediate memory, delayed memory and attention. Associations were strongest in those aged 60-70, with no associations observed in those >80 years. CONCLUSIONS: Reduced kidney function was associated with poorer global and domain-specific neuropsychological performance. Associations were strongest with eGFR <45 ml/min/1.73 m2 and in those aged 60-70 years, suggesting that this population may potentially benefit from potential multi-domain interventions aimed at promoting optimal brain health in older adults.

Clinical and operational insights from data-driven care pathway mapping: a systematic review.

BACKGROUND: Accumulated electronic data from a wide variety of clinical settings has been processed using a range of informatics methods to determine the sequence of care activities experienced by patients. The "as is" or "de facto" care pathways derived can be analysed together with other data to yield clinical and operational information. It seems likely that the needs of both health systems and patients will lead to increasing application of such analyses. A comprehensive review of the literature is presented, with a focus on the study context, types of analysis undertaken, and the utility of the information gained. METHODS: A systematic review was conducted of literature abstracting sequential patient care activities ("de facto" care pathways) from care records. Broad coverage was achieved by initial screening of a Scopus search term, followed by screening of citations (forward snowball) and references (backwards snowball). Previous reviews of related topics were also considered. Studies were initially classified according to the perspective captured in the derived pathways. Concept matrices were then derived, classifying studies according to additional data used and subsequent analysis undertaken, with regard for the clinical domain examined and the knowledge gleaned. RESULTS: 254 publications were identified. The majority (n = 217) of these studies derived care pathways from data of an administrative/clinical type. 80% (n = 173) applied further analytical techniques, while 60% (n = 131) combined care pathways with enhancing data to gain insight into care processes. DISCUSSION: Classification of the objectives, analyses and complementary data used in data-driven care pathway mapping illustrates areas of greater and lesser focus in the literature. The increasing tendency for these methods to find practical application in service redesign is explored across the variety of contexts and research questions identified. A limitation of our approach is that the topic is broad, limiting discussion of methodological issues. CONCLUSION: This review indicates that methods utilising data-driven determination of de facto patient care pathways can provide empirical information relevant to healthcare planning, management, and practice. It is clear that despite the number of publications found the topic reviewed is still in its infancy.

Moderating the relationship between diabetes distress and mastery: the role of depression and empowerment.

Type 2 diabetes is a chronic condition primarily self-managed by the individual. Mastery is a protective factor linked to better control of chronic conditions, effective self-management and improved medication adherence. Mastery appears increasingly important as treatment regimens and self-management demands become more complex and burdensome. Diabetes distress negatively impacts self-management, glycaemic control and treatment adherence. Understanding the relationship between diabetes distress and mastery may provide opportunities to improve condition management and adherence . This relationship may be impacted by other factors affecting the individual's perceived sense of control over their condition. This study examined the role of diabetes empowerment and depression in the relationship between diabetes distress and mastery. Data were drawn from a randomised controlled trial of 131 adults with type 2 diabetes transitioning to injection therapy. Participants completed measures of diabetes distress , mastery , depression and empowerment . Diabetes distress and depression were negatively associated with mastery, whilst diabetes empowerment was positively associated . A significant interaction effect (b = .024, t(112) = 3.79, p = <.005) confirmed the relationship between diabetes distress and mastery was moderated by depression. Findings highlight the additive deleterious effects of depression. Interventions to improve mastery among those living with type 2 diabetes should address diabetes distress and depression to optimise outcomes.

Impact of the common MTHFR 677C→T polymorphism on blood pressure in adulthood and role of riboflavin in modifying the genetic risk of hypertension: evidence from the JINGO project.

BACKGROUND: Genome-wide and clinical studies have linked the 677C→T polymorphism in the gene encoding methylenetetrahydrofolate reductase (MTHFR) with hypertension, whilst limited evidence shows that intervention with riboflavin (i.e. the MTHFR co-factor) can lower blood pressure (BP) in hypertensive patients with the variant MTHFR 677TT genotype. We investigated the impact of this common polymorphism on BP throughout adulthood and hypothesised that riboflavin status would modulate the genetic risk of hypertension. METHODS: Observational data on 6076 adults of 18-102 years were drawn from the Joint Irish Nutrigenomics Organisation project, comprising the Trinity-Ulster Department of Agriculture (TUDA; volunteer sample) and the National Adult Nutrition Survey (NANS; population-based sample) cohorts. Participants were recruited from the Republic of Ireland and Northern Ireland (UK) in 2008-2012 using standardised methods. RESULTS: The variant MTHFR 677TT genotype was identified in 12% of adults. From 18 to 70 years, this genotype was associated with an increased risk of hypertension (i.e. systolic BP ≥ 140 and/or a diastolic BP ≥ 90 mmHg): odds ratio (OR) 1.42, 95% confidence interval (CI) 1.07 to 1.90; P = 0.016, after adjustment for antihypertensive drug use and other significant factors, namely, age, male sex, BMI, alcohol and total cholesterol. Low or deficient biomarker status of riboflavin (observed in 30.2% and 30.0% of participants, respectively) exacerbated the genetic risk of hypertension, with a 3-fold increased risk for the TT genotype in combination with deficient riboflavin status (OR 3.00, 95% CI, 1.34-6.68; P = 0.007) relative to the CC genotype combined with normal riboflavin status. Up to 65 years, we observed poorer BP control rates on antihypertensive treatment in participants with the TT genotype (30%) compared to those without this variant, CT (37%) and CC (45%) genotypes (P < 0.027). CONCLUSIONS: The MTHFR 677TT genotype is associated with higher BP independently of homocysteine and predisposes adults to an increased risk of hypertension and poorer BP control with antihypertensive treatment, whilst better riboflavin status is associated with a reduced genetic risk. Riboflavin intervention may thus offer a personalised approach to prevent the onset of hypertension in adults with the TT genotype; however, this requires confirmation in a randomised trial in non-hypertensive adults.

New models of atherosclerosis and multi-drug therapeutic interventions.

MOTIVATION: Atherosclerosis is amongst the leading causes of death globally. However, it is challenging to study in vivo or in vitro and no detailed, openly-available computational models exist. Clinical studies hint that pharmaceutical therapy may be possible. Here, we develop the first detailed, computational model of atherosclerosis and use it to develop multi-drug therapeutic hypotheses. RESULTS: We assembled a network describing atheroma development from the literature. Maps and mathematical models were produced using the Systems Biology Graphical Notation and Systems Biology Markup Language, respectively. The model was constrained against clinical and laboratory data. We identified five drugs that together potentially reverse advanced atheroma formation. AVAILABILITY AND IMPLEMENTATION: The map is available in the Supplementary Material in SBGN-ML format. The model is available in the Supplementary Material and from BioModels, a repository of SBML models, containing CellDesigner markup. SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

Computational modelling of atherosclerosis.

Atherosclerosis is one of the principle pathologies of cardiovascular disease with blood cholesterol a significant risk factor. The World Health Organization estimates that approximately 2.5 million deaths occur annually because of the risk from elevated cholesterol, with 39% of adults worldwide at future risk. Atherosclerosis emerges from the combination of many dynamical factors, including haemodynamics, endothelial damage, innate immunity and sterol biochemistry. Despite its significance to public health, the dynamics that drive atherosclerosis remain poorly understood. As a disease that depends on multiple factors operating on different length scales, the natural framework to apply to atherosclerosis is mathematical and computational modelling. A computational model provides an integrated description of the disease and serves as an in silico experimental system from which we can learn about the disease and develop therapeutic hypotheses. Although the work completed in this area to date has been limited, there are clear signs that interest is growing and that a nascent field is establishing itself. This article discusses the current state of modelling in this area, bringing together many recent results for the first time. We review the work that has been done, discuss its scope and highlight the gaps in our understanding that could yield future opportunities.

The genetics and screening of familial hypercholesterolaemia.

Familial Hypercholesterolaemia is an autosomal, dominant genetic disorder that leads to elevated blood cholesterol and a dramatically increased risk of atherosclerosis. It is perceived as a rare condition. However it affects 1 in 250 of the population globally, making it an important public health concern. In communities with founder effects, higher disease prevalences are observed.We discuss the genetic basis of familial hypercholesterolaemia, examining the distribution of variants known to be associated with the condition across the exons of the genes LDLR, ApoB, PCSK9 and LDLRAP1. We also discuss screening programmes for familial hypercholesterolaemia and their cost-effectiveness. Diagnosis typically occurs using one of the Dutch Lipid Clinic Network (DCLN), Simon Broome Register (SBR) or Make Early Diagnosis to Prevent Early Death (MEDPED) criteria, each of which requires a different set of patient data. New cases can be identified by screening the family members of an index case that has been identified as a result of referral to a lipid clinic in a process called cascade screening. Alternatively, universal screening may be used whereby a population is systematically screened.It is currently significantly more cost effective to identify familial hypercholesterolaemia cases through cascade screening than universal screening. However, the cost of sequencing patient DNA has fallen dramatically in recent years and if the rate of progress continues, this may change.

Clinical and diagnostic findings in patients with elevated cerebrospinal bilirubin.

INTRODUCTION: Cerebrospinal fluid (CSF) spectroscopy can identify subarachnoid haemorrhage (SAH) when CT is negative in patients presenting with acute severe headache. The primary objective of this study was to evaluate the clinical use and usefulness of CSF spectrophotometry. Secondary objectives were to identify other causes of elevated CSF bilirubin, to analyse headache descriptions and to compare clinical features in patients with an elevated CSF bilirubin among those with and without an intracranial vascular cause of SAH (avSAH). METHODS: Consecutive patients admitted to two hospitals in Enniskillen and Londonderry between 1 January 2004 and 30 September 2014 with CSF spectroscopy bilirubin results were identified from a clinical chemistry laboratory dataset. Patients with elevated CSF bilirubin were studied. Clinical demographics, delays to investigation and final diagnoses were recorded. Patients with avSAH were compared with patients without avSAH. RESULTS: Among 1813 patients with CSF spectrophotometry results, requests increased more than threefold during the study (p<0.001). Fifty-six patients had elevated CSF bilirubin. Ten (17.9%) had avSAH, of which 8 (14.3%) had aneurysmal SAH. Non-vascular causes of elevated CSF bilirubin included meningitis, spontaneous intracranial hypotension and carcinomatous meningitis. Headache descriptions varied. Time from headache onset to admission, CT scan and lumbar puncture did not differ significantly for patients with avSAH and non-avSAH. CSF red cell counts were higher among patients with avSAH than patients with non-avSAH (p=0.005). CONCLUSIONS: CSF bilirubin measurement has an important role in identifying avSAH in CT-negative patients presenting with a thunderclap headache. Better clinical selection of patients is required as CSF spectrophotometry, although sensitive, is not specific for SAH.

Low-Grade systemic inflammation is associated with domain-specific cognitive performance and cognitive decline in older adults: Data from the TUDA study.

Studies examining the relationships between chronic inflammation, cognitive function and cognitive decline in older adults have yielded conflicting results. In a large cohort of older adults free from established dementia (n = 3270; 73.1 ± 7.9 years; 68.4% female), we evaluated the cross-sectional and longitudinal relationships between serum cytokines (IL-6, IL-10, TNF-α) and both global and domain-specific cognitive performance (Repeatable Battery for Assessment of Neuropsychological Status [RBANS]). Higher IL-6 (OR: 1.33; 1.06, 1.66, p = 0.01), TNF-α (OR: 1.35; 1.09, 1.67, p = 0.01) and IL-6:IL-10 Ratio (OR: 1.43; 1.17, 1.74, p = 0.001) were cross-sectionally associated with impaired global RBANS performance. For specific cognitive domains, greatest effect sizes were observed between higher TNF-α levels and poorer visual-spatial and attention performance. In a subset of participants (n = 725; 69.8 ± 5.5 years; 67.0% female) with repeat assessment performed at a median of 5.4 years, only higher baseline IL-6:IL-10 ratio was associated with impaired incident overall, immediate memory and visual-spatial performance. Associations were stronger in females, but not modified by age or APOE genotype.

Identification of nutrition factors in the metabolic syndrome and its progression over time in older adults: analysis of the TUDA cohort.

BACKGROUND: Nutrition is recognized as playing an important role in the metabolic syndrome (MetS), but the dietary components involved are unclear. We aimed to investigate nutrition factors in relation to MetS and its progression in older adults over a follow-up period of 5.4 years. METHODS: Community-dwelling adults (≥ 60y) from the Trinity-Ulster-Department-of-Agriculture study, sampled at baseline (2008-12) and follow-up (2014-18; n 953), were classified as 'with MetS' by having three or more of: waist circumference (≥ 102 cm, males; ≥ 88 cm, females); HDL-cholesterol (< 1.0 mmol/L, males; < 1.3 mmol/L, females); triglycerides (≥ 1.7 mmol/L); blood pressure (systolic ≥ 130 and/or diastolic ≥ 85 mmHg); and hemoglobin A1c (≥ 39 mmol/mol). RESULTS: MetS was identified in 67% of participants, increasing to 74% at follow-up. Predictors at baseline for the development of metabolic syndrome (MetS) at follow-up were higher waist circumference (odds ratio [95%CI]; 1.06 [1.01-1.11]), but not BMI, and increased triglyceride concentrations (2.01 [1.29-3.16]). In dietary analysis (at follow-up), higher protein (g/kg bodyweight/day) and monounsaturated fatty acid (g/day) intakes were each associated with lower risk of MetS (0.06 [0.02-0.20] and 0.88 [0.78-1.00], respectively), whilst higher protein was also associated with lower abdominal obesity (0.10 [0.02-0.51]) and hypertension (0.22 [0.00-0.80]). Furthermore, participants with, compared to without, MetS consumed less high-quality protein foods (P = 0.006) and more low-quality protein foods (P < 0.001), as defined by the protein digestibility-corrected amino acid score. CONCLUSIONS: Dietary interventions targeting protein quantity and quality may have specific benefits in preventing or delaying the progression of MetS in at-risk older people, but this requires investigation in the form of randomized trials.

Analysis of SARS-CoV-2 antibody seroprevalence in Northern Ireland during 2020-2021.

Background: With the spread of SARS-CoV-2 impacting upon public health directly and socioeconomically, further information was required to inform policy decisions designed to limit virus spread during the pandemic. This study sought to contribute to serosurveillance work within Northern Ireland to track SARS-CoV-2 progression and guide health strategy. Methods: Sera/plasma samples from clinical biochemistry laboratories were analysed for anti-SARS-CoV-2 antibodies. Samples were assessed using an Elecsys anti-SARS-CoV-2 or anti-SARS-CoV-2 S ECLIA (Roche) on an automated cobas e 801 analyser. Samples were also assessed via an anti-SARS-CoV-2 ELISA (Euroimmun). A subset of samples assessed via the Elecsys anti-SARS-CoV-2 ECLIA were subsequently analysed in an ACE2 pseudoneutralisation assay using a V-PLEX SARS-CoV-2 Panel 7 for IgG and ACE2 (Meso Scale Diagnostics). Results: Across three testing rounds (June-July 2020, November-December 2020 and June-July 2021 (rounds 1-3 respectively)), 4844 residual sera/plasma specimens were assayed for anti-SARS-CoV-2 antibodies. Seropositivity rates increased across the study, peaking at 11.6 % (95 % CI 10.4 %-13.0 %) during round 3. Varying trends in SARS-CoV-2 seropositivity were noted based on demographic factors. For instance, highest rates of seropositivity shifted from older to younger demographics across the study period. In round 3, Alpha (B.1.1.7) variant neutralising antibodies were most frequently detected across age groups, with median concentration of anti-spike protein antibodies elevated in 50-69 year olds and anti-S1 RBD antibodies elevated in 70+ year olds, relative to other age groups. Conclusions: With seropositivity rates of <15 % across the assessment period, it can be concluded that the significant proportion of the Northern Ireland population had not yet naturally contracted the virus by mid-2021.

A comparison of the Netherlands, Norway and UK familial hypercholesterolemia screening programmes with implications for target setting and the UK's NHS long term plan.

We sought to determine the most efficacious and cost-effective strategy to follow when developing a national screening programme by comparing and contrasting the national screening programmes of Norway, the Netherlands and the UK. Comparing the detection rates and screening profiles between the Netherlands, Norway, the UK and constituent nations (England, Northern Ireland, Scotland and Wales) it is clear that maximising the number of relatives screened per index case leads to identification of the greatest proportion of an FH population. The UK has stated targets to detect 25% of the population of England with FH across the 5 years to 2024 with the NHS Long Term Plan. However, this is grossly unrealistic and, based on pre-pandemic rates, will only be reached in the year 2096. We also modelled the efficacy and cost-effectiveness of two screening strategies: 1) Universal screening of 1-2-year-olds, 2) electronic healthcare record screening, in both cases coupled to reverse cascade screening. We found that index case detection from electronic healthcare records was 56% more efficacious than universal screening and, depending on the cascade screening rate of success, 36%-43% more cost-effective per FH case detected. The UK is currently trialling universal screening of 1-2-year-olds to contribute to national FH detection targets. Our modelling suggests that this is not the most efficacious or cost-effective strategy to follow. For countries looking to develop national FH programmes, screening of electronic healthcare records, coupled to successful cascade screening to blood relatives is likely to be a preferable strategy to follow.

Can Clinical Outcomes Be Improved, and Inpatient Length of Stay Reduced for Adults With Diabetes? A Systematic Review.

Aim: To examine the efficacy of clinical practice strategies in improving clinical outcomes and reducing length of hospital stay for inpatients with Type 1 and Type 2 diabetes. Background: People living with diabetes are at increased risk of being admitted to hospital and to stay in hospital longer than those who do not have the condition. Diabetes and its complications cause substantial economic loss to those living with the condition, their families, to health systems and national economies through direct medical costs and loss of work and wages. Length of stay is a major factor driving up hospitalisation costs relating to those with Type 1 and Type 2 diabetes with suboptimal blood glucose management, hypoglycaemia, hyperglycaemia, and co-morbidities shown to considerably impact upon length of stay. The identification of attainable evidence-based clinical practice strategies is necessary to inform the knowledge base and identify service improvement opportunities that could lead to improved clinical outcomes for these patients. Study Design: A systematic review and narrative synthesis. Methods: A systematic search of CINAHL, Medline Ovid, and Web of Science databases was carried out to identify research papers reporting on interventions that have reduced length of hospital stay for inpatients living with diabetes for the period 2010-2021. Selected papers were reviewed, and relevant data extracted by three authors. Eighteen empirical studies were included. Results: Eighteen studies spanned the themes of clinical management innovations, clinical education programmes, multidisciplinary collaborative care and technology facilitated monitoring. The studies demonstrated improvements in healthcare outcomes such as glycaemic control, greater confidence with insulin administration and reduced occurrences of hypoglycaemia and hyperglycaemia and decreased length of hospital stay and healthcare costs. Conclusions: The clinical practice strategies identified in this review contribute to the evidence base for inpatient care and treatment outcomes. The implementation of evidence-based research can improve clinical practice and show that appropriate management can enhance clinical outcomes for the inpatient with diabetes, potentially leading to reductions in length of stay. Investment in and commissioning of practices that have the potential to afford clinical benefits and reduce length of hospital stay could influence the future of diabetes care. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=204825, identifier 204825.

Health economic evaluations of medical tests: Translating laboratory information into value - A case study example.

Health-care providers and funders are focused on identifying value in all their services and that includes laboratories. This means that in order to gain a share of scarce resources, laboratory professionals must also understand and assess the value of tests and that includes their economic impact. This can be assessed using health economic modelling tools which, when used in conjunction with a detailed value proposition for the test, can translate laboratory information into value. While a variety of health economic assessment tools are available, this review will focus on the use of decision analytic models which essentially compare the outcomes from pathways with and without the new test, the value of which is being assessed. A step-by-step framework is provided to guide laboratory professionals through the essential steps of conducting the evaluation. Initial steps include mapping the clinical pathway, understanding the goal of the evaluation, identifying the key stakeholders and their needs and determining a suitable analytical model. Following collection of the actual data, the validity of the model must be checked, and the robustness of the outcomes tested through sensitivity analysis. The last step is to translate the findings into measures of value which can then inform appropriate decisions by the stakeholders. This review of basic health economic modelling should enable laboratory professionals to have an understanding of how modelling can be applied to tests in their own environment and help deliver their potential value.

Simvastatin is associated with superior lipid and glycaemic control to atorvastatin and reduced levels of incident Type 2 diabetes, in men and women, in the UK Biobank.

INTRODUCTION: Cardiovascular disease (CVD) is the leading cause of mortality in people with Type 2 diabetes mellitus (T2DM). Statins reduce low-density lipoproteins and positively affect CVD outcomes. Statin type and dose have differential effects on glycaemia and risk of incident T2DM; however, the impact of gender, and of individual drugs within the statin class, remains unclear. AIM: To compare effects of simvastatin and atorvastatin on lipid and glycaemic control in men and women with and without T2DM, and their association with incident T2DM. METHODS: The effect of simvastatin and atorvastatin on lipid and glycaemic control was assessed in the T2DM DiaStrat cohort. Prescribed medications, gender, age, BMI, diabetes duration, blood lipid profile and HbA1c were extracted from Electronic Care Record, and compared in men and women prescribed simvastatin and atorvastatin. Analyses were replicated in the UKBiobank in those with and without T2DM. The association of simvastatin and atorvastatin with incident T2DM was also investigated in the UKBiobank. Cohorts where matched for age, BMI and diabetes duration in men and women, in the UKBioBank analysis, where possible. RESULTS: Simvastatin was associated with better LDL (1.6 ± 0.6 vs 2.1 ± 0.9 mmol/L, p < .01) and total cholesterol (3.6 ± 0.7 vs 4.2 ± 1.0 mmol/L, p < .05), and glycaemic control (62 ± 17 vs 67 ± 19 mmol/mol, p < .059) than atorvastatin specifically in women in the DiaStrat cohort. In the UKBiobank, both men and women prescribed simvastatin had better LDL (Women: 2.6 ± 0.6 vs 2.6 ± 0.7 mmol/L, p < .05; Men: 2.4 ± 0.6 vs 2.4 ± 0.6, p < .01) and glycaemic control (Women:54 ± 14 vs 56 ± 15mmol/mol, p < .05; Men, 54 ± 14 vs 55 ± 15 mmol/mol, p < .01) than those prescribed atorvastatin. Simvastatin was also associated with reduced risk of incident T2DM in both men and women (p < .0001) in the UKBiobank. CONCLUSIONS: Simvastatin is associated with superior lipid and glycaemic control to atorvastatin in those with and without T2DM, and with fewer incident T2DM cases. Given the importance of lipid and glycaemic control in preventing secondary complications of T2DM, these findings may help inform prescribing practices.

Quality error rates in point-of-care testing.

BACKGROUND: Although a theoretical consideration suggests that point-of-care testing (POCT) might be uniquely vulnerable to error, little information is available on the quality error rate associated with POCT. Such information would help inform risk/benefit analyses when one considers the introduction of POCT. METHODS: This study included 1 nonacute and 2 acute hospital sites. The 2 acute sites each had a 24-h central laboratory service. POCT was used for a range of tests, including blood gas/electrolytes, urine pregnancy testing, hemoglobin A(1c) (Hb A(1c)), blood glucose, blood ketones, screening for drugs of abuse, and urine dipstick testing. An established Quality Query reporting system was in place to log and investigate all quality errors associated with POCT. We reviewed reports logged over a 14-month period. RESULTS: Over the reporting period, 225 Quality Query reports were logged against a total of 407 704 POCT tests. Almost two-thirds of reports were logged by clinical users, and the remainder by laboratory staff. The quality error rate ranged from 0% for blood ketone testing to 0.65% for Hb A(1c) testing. Two-thirds of quality errors occurred in the analytical phase of the testing process. These errors were all assessed as having no or minimal adverse impact on patient outcomes; however, the potential adverse impact was graded higher. CONCLUSIONS: The quality error rate for POCT is variable and may be considerably higher than that reported previously for central laboratory testing.