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Chronic disease poses a major burden to patients and health care systems. This review considers how patient self-testing can contribute to the management of chronic disease. Self-testing can only confer benefit if it occurs in the context of an empowered patient who has the skills and training to translate test results into meaningful actions. The benefits may include improved clinical outcomes, greater patient convenience and improved psychological well-being; separately and together these may contribute to reduced costs of care. As self-testing may be expensive and burdensome to patients, it is important that its use in chronic disease is supported by a robust evidence base confirming its utility and efficacy. The design of studies to assess the impact of self-testing poses challenges for the researcher and the quality of evidence presented is often variable. Randomised controlled trials (RCTs) provide more robust evidence than observational studies; the intervention under study is not just self-testing but includes the educational support to allow patients to use results effectively. This review discusses the evidence base relating to patient self-testing in diabetes, anticoagulant monitoring and in renal transplant patients and in particular highlights the impact of new technology developments such as flash glucose monitoring in diabetes. [ABSTRACT FROM AUTHOR]

Multiple myeloma is a malignant plasma cell dyscrasia that is becoming more prevalent in an increasingly ageing population. It is a complex disease with clinical phases ranging from the premalignant monoclonal gammopathy of undetermined significance to asymptomatic (smouldering) myeloma and then symptomatic myeloma; the latter occasionally terminating in the clonal proliferation of plasma cells outside the bone marrow. We present a patient whose clonally evolved disease from monoclonal gammopathy of undetermined significance to multiple myeloma demonstrated the presence of an unusual combination of monoclonal immunoproteins. Capillary electrophoresis demonstrated the presence of three paraproteins in the gamma region (γ-region), two of which were additional to the IgGk paraprotein which migrated in the slow γ-region at initial diagnosis. Subsequent isotypic identification of the new paraproteins was not possible by immunotyping and initial immunofixation studies failed to definitively characterize the monoclonal proteins. After reduction with beta-mercaptoethanol, two paraproteins were detected by both capillary and gel electrophoresis. However, only immunofixation was able to resolve three distinct monoclonal bands, confirming the presence of free monoclonal kappa light chains in the mid-gamma region and free monoclonal heavy chains in the fast gamma region. Triple gammopathies in themselves are uncommon; this case presents a very unusual combination of paraproteins which required various electrophoretical and immunochemical techniques to identify and characterize them. The change of electrophoretic signature from the monoclonal gammopathy of undetermined significance phase to the diagnosis of multiple myeloma suggested that a number of genetically distinct subclones were present in the pretreatment clonal evolution of the disease. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To investigate the relationship between area‐level deprivation and risk of cognitive dysfunction. DESIGN: Cross‐sectional analysis. SETTING: The Trinity, Ulster, and Department of Agriculture (TUDA) study from 2008 to 2012. PARTICIPANTS: Community‐dwelling adults aged 74.0 ± 8.3 without dementia (N = 5,186; 67% female). MEASUREMENTS: Adopting a cross‐jurisdictional approach, geo‐referenced address‐based information was used to map and link participants to official socioeconomic indicators of deprivation within the United Kingdom and the Republic of Ireland. Participants were assigned an individual deprivation score related to the smallest administrative area in which they lived. These scores were categorized into comparable quintiles, that were then used to integrate the datasets from both countries. Cognitive health was assessed using the Mini‐Mental State Examination (MMSE); cognitive dysfunction was defined as a MMSE score of 24 or less. RESULTS: Approximately one‐quarter of the cohort resided within the most‐deprived districts in both countries. Greater area‐level deprivation was associated with significantly lower MMSE scores; fewer years of formal education; greater anxiety, depression, smoking and alcohol use, and obesity; and more adverse outcomes, including higher blood pressure and diabetes risk. After adjustment for relevant covariates, area deprivation was associated with significantly higher risk of cognitive dysfunction (odds ratio = 1.40, 95% confidence interval = 1.05–1.87, P = .02, for most vs least deprived). CONCLUSION: This analysis combining data from two health systems shows that area deprivation is an independent risk factor for cognitive dysfunction in older adults. Adults living in areas of greatest socioeconomic deprivation may benefit from targeted strategies aimed at improving modifiable risk factors for dementia. Further cross‐national analysis investigating the impact of area‐ level deprivation is needed to address socioeconomic disparities and shape future policy to improve health outcomes in older adults.© 2018 American Geriatrics Society and Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This article reports on a study which explored the potential of structural equation model to deal with measurement error using as an exemplar the estimation of an estimated average glucose regression equation. Researchers used data from a 12-month randomised controlled trial aimed at assessing the effect of self monitoring of blood glucose on glycaemic control in patients with newly diagnosed type 2 diabetes. It is suggested that the approach have wider applications in laboratory medicine.

Heterozygous familial hypercholesterolemia (HeFH) is an autosomal dominant condition with a population prevalence of 1 in 500, and is associated with significant cardiovascular morbidity and mortality. It may be caused by mutations in the low-density lipoprotein (LDL) receptor, apolipoprotein B100 (Apo B100), or proprotein convertase subtilisin/kexin type 9 (PCSK9) genes, with over 1,000 causative mutations described. Statin therapy in HeFH is considered effective and safe. Audit data suggest that approximately 80% of the putative HeFH population remains unidentified and, therefore, there is a need to develop a strategy for the identification of affected individuals so that early lipid-lowering treatment may be offered. There is good evidence showing the effectiveness and acceptability of HeFH screening programs in Europe. The authors describe a protocol for an all island approach to HeFH detection in the Republic of Ireland/Northern Ireland. Index cases will be identified by opportunistic screening using the Simon Broome, or Make Early Diagnosis to Prevent Early Death (MedPed) and World Health Organization (WHO) criteria. Patients identified as 'definite,' 'probable,' or 'possible' HeFH criteria will be offered genetic testing. The authors expect causative mutations to be identified in approximately 80% of patients with 'definite' HeFH but in only approximately 20% of patients with 'possible' HeFH. Cascade screening will be undertaken in first-degree relatives of the index case using genetic testing (where a causative mutation has been identified), or otherwise using LDL cholesterol concentration. The establishment of a HeFH screening program on an all-island basis will require: expansion of the existing molecular genetics diagnostic services, the establishment of a cohort of nurses/genetic counselors, a HeFH database to support cascade testing, the development of a network of lipid clinics (in a primary or secondary care setting), and an educational initiative to raise awareness of HeFH among healthcare professionals and the general population. [ABSTRACT FROM AUTHOR]

Aim: To describe differences in biochemistry test request rates (adjusted for practice size) between general practices and to investigate whether differences in HbA1C and thyroid function test request rates are related either to the practice prevalence of hypothyroidism and diabetes or to Quality and Outcome Framework (QOF) scores. Methods: Information on test request rates, prevalence of diabetes and hypothyroidism, and QOF data over a one-year period were obtained from 58 practices covering a population of 284,609 patients. Spearman's rank correlation tests were used to investigate relationships between adjusted test request rates. Results: There was wide variability in adjusted test request rates (lowest for HbA1C and highest for immunoglobulins). The ranking of practices for different tests was highly correlated. There was no relationship between adjusted test request rates for HbA1C and thyroid function and the reported prevalence of diabetes and hypothyroidism, respectively, nor was there any relationship with QOF scores in diabetes and hypothyroidism. Conclusions: There is wide variability in test request rates in general practice that do not appear to be related to disease prevalence or crude clinical outcome measures. [ABSTRACT FROM AUTHOR]

Self-monitoring of blood glucose (SMBG) is advocated as a valuable aid in the management of diabetes. The volume and cost of monitoring continues to increase. SMBG has a number of theoretical advantages/disadvantages which might impact on treatment, outcome and wellbeing. Investigating and quantifying the effect of self-monitoring in a condition where self-management plays a central role poses major methodological difficulties because of the need to minimize confounding factors. Despite the absence of definitive evidence, some situations where monitoring is generally accepted to be beneficial include patients on insulin, during pregnancy, in patients with hypoglycaemia unawareness and while driving. An area of controversy is the role of monitoring in non-insulin-requiring type-2 diabetes where observational and controlled studies give conflicting results. The available evidence does not support the general use of monitoring by all patients with type-2 diabetes, although further research is needed to identify specific subgroups of patients or specific situations where monitoring might be useful. The best use of SMBG in patients with type-2 diabetes might be for those receiving insulin and those on sulphonylurea drugs. The impact of monitoring on patient wellbeing must also be considered, with some studies suggesting adverse psychological effects. Given the large increase in the prevalence of type-2 diabetes, it will be important to define the role of SMBG so that resources can be used appropriately. Presently, the widespread use of SMBG (particularly in type-2 diabetes patients) is a good example of self-monitoring that was adopted in advance of robust evidence of its clinical efficacy. [ABSTRACT FROM AUTHOR]

Objectives To assess the effect of self monitoring of blood glucose concentrations on glycaemic control and psychological indices in patients with newly diagnosed type 2 diabetes mellitus. Design Prospective randomised controlled trial of self monitoring versus no monitoring (control). Setting Hospital diabetes clinics. Participants 184 (111 men) people aged <70 with newly diagnosed type 2 diabetes referred to the participating diabetes clinics. Major exclusion criteria were secondary diabetes, insulin treatment, previous self monitoring of blood glucose. Interventions Participants were randomised to self ¦ monitoring or no monitoring (control) groups for one year with follow-up at three monthly intervals. Both groups underwent an identical structured core education programme.The self monitoringgroup received additional education on monitoring. Main outcome measures Between group differences in HbAlc, psychological indices, use of oral hypoglycaemic drugs, body mass index (BMI), and reported hypoglycaemia rates. Results 96 patients (55 men) were randomised to monitoring and 88 (56 men) to control. There were no baseline differences in mean (SD) age (57.7 (11.0) in monitoringgroup v60.9 (11.5) in control group) orHbAlc (8.8 (2.1)% 1/8.6 (2.3)%, respectively). Those in the monitoring group had a higher baseline BMI (34 (7) v 32 (6.2)). There were no significant differences between groups at any time point (12 months values given) in HbAlc (6.9 (0.8)% v 6.9 (1.2)%, P=0.69; 95% confidence interval for difference-0.2 5% to 0.38%), BMI (33.1 (6.4) v 31.8 (6.0); adjusted for baseline BMI, P=0.32), use of oral hypoglycaemic drugs, or reported incidence of hypoglycaemia. Monitoring was associated with a 6% higher score on the depression subscale of the well-being questionnaire (P=0.01). Conclusions In patients with newly diagnosed type 2 diabetes self monitoring of blood glucose concentration has no effect on glycaemic control but is associated with higher scores on a depression subscale. Trial registration ISRCTN 49814766. [ABSTRACT FROM AUTHOR]

Background: There is no agreed system for the reporting, classification and grading of the severity of quality failures in the clinical biochemistry laboratory. Methods: A 'Quality Query' reporting system was set up to log all quality failures identified by staff and service users. Quality failures were classified into three major groups of the preanalytical, analytical and postanalytical phases with appropriate subcategories in each group. The severity of each quality failure was graded using a five-point scoring system incorporating both actual ('A') and potential ('P') score elements. The 'A' score measured the actual adverse impact of the quality failure on patient care, while the 'P' score measured the 'worst case' potential outcome that might have resulted. The system was assessed over a 19-month period. Results: Three hundred and ninety-seven Quality Query reports were completed (0.085% of all requests). Breakdown by cause: pre-analytical phase – 88.9%, analytical phase – 9.6%, post-analytical phase – 1.5%. The quality failure severity 'A' scores were skewed towards a low adverse impact on patient care: 72.7% allocated an 'A' score of 1 (least severe grade). The 'P' scores were skewed towards a high potential impact on patient care: 65.9% allocated a 'P' score of 5 (most severe grade). Conclusions: The Quality Query reporting system proved easy to integrate into routine laboratory practice. Although the great majority of quality failures had minimal adverse impact on patient care, the potential for adverse outcomes was much higher. This system generates important information on laboratory performance and helps inform risk management priorities. [ABSTRACT FROM AUTHOR]

• Obtaining valid inferences from observational research using electronic health records is challenging due to selection bias, confounding and missing data. • Use of target trial emulation may increase the value of results from observational research by reducing the risk of selection bias, immortal time bias and confounding. • Target trial emulation can be a means to reduce the risk of bias by comparing the observational study performed to the perfect target trial. • When using EHR data to emulate a target trial, samples containing sufficient information on outcome measures and variables to adjust for confounding and selection bias are essential given the risk of missing data. Electronic health records (EHRs) are increasingly used in effectiveness and safety research. However, these studies are often at risk of bias. This study demonstrates the relevance, and discusses challenges, of using target trial emulation to avoid bias, such as selection bias, immortal time bias and confounding when performing observational research with EHRs. Target trial emulation can be used to identify and address some of the drawbacks of observational research in a systematic way. Potential sources of bias are identified by describing key components of an ideal randomized controlled trial and comparing this to the observational study actually performed. The methods were applied to assess treatment response to antidiabetic treatment using EHRs from patients with diabetes treated in secondary care. Using target trial emulation ensured prevalent users were excluded and patients were not included based on information generally not available when initiating a clinical trial. Furthermore, applying these methods demonstrated how the number of records eligible for use can rapidly decrease. Hereafter, adjustments were performed to address potential sources of bias and it was shown that missing variables essential for adjustment can be an important issue. Using target trial emulation, sources of selection bias and confounding were identified and adjusted for accordingly when analysing treatment response in patients with type 2 diabetes. However, when using EHR data to emulate a target trial, samples containing sufficient information on outcome measures and variables to adjust for confounding and selection bias are essential given the risk of missing data. [ABSTRACT FROM AUTHOR]

The article focuses on the evidence base for laboratory medicine. It states that laboratory medicine aims to provide information that will help people either to maintain their health or in the event of illness to regain their health. It further discusses various ways to use laboratory tests which includes screening of asymptomatic subjects, diagnosis of disease and monitoring disease progression.

The article discusses a study which compared hemolysis rates in blood gas samples taken in an intensive care unit (ICU) with those taken in and emergency department (ED) in Altnagelvin Hospital. Topics include categories of samples, hemolysis rates in 100 whole blood samples from each of ED and ICU, and the need of instrument manufacturers to consider the introduction of hemolysis checks in whole blood analyzers.

The article presents the author's views on the implication of patient's direct access to test results on clinical and laboratory practice. Topics discussed includes cancer diagnosis, laws enforced by the U.S. Department of Health and Human Services regarding the availability of test results and online portal Renal Patient View.

An introduction to the journal is presented in which the editors discuss the importance of cerebrospinal fluid (CSF) spectrophotometry in the accurate diagnosis of subarachnoid haemorrhage (SAH).

The article discusses the evolution of point-of-care testing (POCT) as documented by a journal on clinical biochemistry. It mentions an article in 1981 which described the acquisition of comprehensive metabolic information by patients who undertook self-sampling. It notes a series of papers in the late 1980s and early 1990s which explained analytical assessment of POCT.

The article examines the effectiveness of accuracy of point-of-care (POC) devices in measuring glucose. It states that POC measuring device of glucose is an important component of tight glycemic control (TGC) regimens in maintaining timely insulin dose adjustment. It notes that POC glucose measurement can operate to a total allowable error of 15%, which was unlikely to produce large insulin dosing errors.