Core Standards of the EUBIROD Project. Defining a European Diabetes Data Dictionary for Clinical Audit and Healthcare Delivery.

BACKGROUND: A set of core diabetes indicators were identified in a clinical review of current evidence for the EUBIROD project. In order to allow accurate comparisons of diabetes indicators, a standardised currency for data storage and aggregation was required. We aimed to define a robust European data dictionary with appropriate clinical definitions that can be used to analyse diabetes outcomes and provide the foundation for data collection from existing electronic health records for diabetes. METHODS: Existing clinical datasets used by 15 partner institutions across Europe were collated and common data items analysed for consistency in terms of recording, data definition and units of measurement. Where necessary, data mappings and algorithms were specified in order to allow partners to meet the standard definitions. A series of descriptive elements were created to document metadata for each data item, including recording, consistency, completeness and quality. RESULTS: While datasets varied in terms of consistency, it was possible to create a common standard that could be used by all. The minimum dataset defined 53 data items that were classified according to their feasibility and validity. Mappings and standardised definitions were used to create an electronic directory for diabetes care, providing the foundation for the EUBIROD data analysis repository, also used to implement the diabetes registry and model of care for Cyprus. CONCLUSIONS: The development of data dictionaries and standards can be used to improve the quality and comparability of health information. A data dictionary has been developed to be compatible with other existing data sources for diabetes, within and beyond Europe.

Quality and safety issues in procedural rural practice: a prospective evaluation of current quality and safety guidelines in 3000 colonoscopies.

INTRODUCTION: Colonoscopy remains the gold standard for the investigation and management of bowel pathology. A 2009 National Bowel Cancer Screening Program Quality Working Group report revealed that small rural towns in inner regional Victoria, Australia, for example Echuca (Rural and Remote Metropolitan Areas [RRMA] 4), registered 10.5 colonoscopies per 1000 population versus 18.5 per 1000 in the state capital Melbourne. Reasons for this discrepancy include lack of skilled practitioners in rural communities and travel time for patients to attend larger centres when the required bowel preparation or mobility issues limit access. Ideally, services are high quality, safe and local. This study assessed the quality and safety of a rural GP colonoscopy service. METHODS: The indications, findings, caecal intubation rates, complications and completion time were recorded for 3000 serial colonoscopies performed by one rural procedural GP from 1995 to 2011 in Victorian Echuca. Quality was assessed using caecal intubation rate, polyp and colorectal carcinoma detection rates, and completion time. Safety was determined by complication rates. RESULTS: The caecal intubation rate was 97% (excluding stenosing lesions), polypectomy detection rate was 39%, carcinoma detection rate was 2%, and the average time to completion was 17 min. Re-admission rates were 1.6/1000 for haemorrhage and 1.2/1000 for perforation. There were no deaths. CONCLUSIONS: The results from this study compare favourably with published international standards, validate Australian general practice procedural training standards, and validate the additional quality measure of 'colonoscopy completion time'. Rural GPs can provide a safe and high quality service. Extending this service model to similar settings could improve reduced access to colonoscopy for rural Australians.

Privacy impact assessment in the design of transnational public health information systems: the BIRO project.

OBJECTIVES: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. MATERIALS AND METHODS: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and conduction of a Delphi procedure. RESULTS: The literature search identified a core set of relevant papers on privacy (n = 11). Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an "aggregation by group of patients" was finally chosen, based upon the exchange of finely tuned summary tables. CONCLUSIONS: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO (Best Information Through Regional Outcomes) project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe.

Breast tumor resembling the tall cell variant of papillary thyroid carcinoma: report of 5 cases.

Five cases of a hitherto undescribed breast tumor having histologic features similar to those of the tall cell variant papillary thyroid carcinoma are described. They were composed of columnar mitochondrion-rich to oxyphilic cells arranged in nests, papillae, and follicle-like structures. In addition, the neoplastic cells showed numerous nuclear grooves and, in two cases, nuclear pseudo-inclusions. None of the patients had previous concomitant or subsequent evidence of a thyroid tumor. Immunohistochemistry further excluded a metastasis from the thyroid in the four cases tested, as they were consistently thyroglobulin and thyroid transcription factor 1 negative.

ACE gene polymorphism as a prognostic indicator in patients with type 2 diabetes and established renal disease.

OBJECTIVE: To investigate whether the DD genotype is a predictor of mortality and of the decline in renal function in patients with type 2 diabetes and established nephropathy. RESEARCH DESIGN AND METHODS: A total of 56 such patients of Maltese Caucasian descent were recruited, and their ACE genotype was determined. Serum creatinine was estimated approximately every 4 months. The glomerular filtration rate (GFR) was calculated according to the Cockroft-Gault formula, and rate of change was determined by regression analysis. RESULTS: The rate of change in calculated GFR was -7.76 ml.min(-1).year(-1) in those with the DD genotype (n = 31) and -1.17 ml. min(-1). h(-1) in those with the ID or II genotype (n = 25) (P < 0.01). The 3-year mortality was 45.2% in the DD group compared with 20.0% in the ID/II group (P < 0.05). CONCLUSIONS: The DD genotype of the ACE gene polymorphism is associated with a more rapid decline in renal function and higher mortality in type 2 diabetic patients with established nephropathy.

Adult height and proteinuria in type 2 diabetes.

BACKGROUND: Short stature has been shown to be associated with proteinuria in type 1 diabetes, but no data exist with respect to type 2 diabetes. The objective of the study was to investigate the relationship between final adult height and macroproteinuria in type 2 diabetic patients. METHODS: One hundred and forty-four consecutive type 2 diabetic patients (84 males, 60 females) with macroproteinuria were recruited into the study. For every patient, three diabetic controls matched for age, gender, and duration of diabetes were randomly selected. Height was measured in patients and controls to the nearest 0.5 cm. RESULTS: The mean height in men with macroproteinuria (n = 84) was 164.4 cm (SD 6.74) compared to 166.6 cm (SD 6.64) in controls (n = 252) (P < 0.01). The mean height in women with macroproteinuria (n = 60) was 150.6 cm (SD 5.20) compared to 152.5 cm (SD 5.78) in controls (n = 180) (P < 0.02). CONCLUSION: Short stature is associated with an increased risk of macroproteinuria in type 2 diabetic patients. We postulate that common genetic or environmental factors that affect final adult height might also predispose to the development of nephropathy.

Increased prevalence of proteinuria in diabetic sibs of proteinuric type 2 diabetic subjects.

There is strong evidence for clustering of renal disease in type 1 diabetes, but few data exist with respect to type 2 diabetes. The objective of this case-control study is to determine whether there is a familial predisposition to the development of proteinuria in patients with type 2 diabetes. Fifty patients with type 2 diabetes with macroproteinuria (protein > or = 500 mg/24 h) with no evidence of causes other than diabetic nephropathy on investigation were identified through routine screening. These patients had 25 living sibs with diabetes, of whom 24 sibs agreed to participate on the study. For each of these sibs, two controls with non-insulin-dependent diabetes were randomly selected, individually matched for age, sex, and duration of diabetes. Twelve of 24 sibs (50%) and 9 of 48 controls (18.8%) had proteinuria (P < 0.01). Systolic and diastolic blood pressure and the proportion on antihypertensive treatment were similar in the two groups. Our data suggest there is increased prevalence of macroproteinuria in diabetic sibs of macroproteinuric patients with type 2 diabetes in a population of white, Caucasian, European descent.

Circadian variation in the onset of acute pulmonary edema and associated acute myocardial infarction in diabetic and nondiabetic patients.

It is known that most acute cardiovascular events exhibit a circadian rhythm in their onset. The authors describe differences in the circadian rhythm of onset of acute pulmonary edema and associated acute myocardial infarction in diabetic and nondiabetic patients.

Outcome of unstable angina in patients with diabetes mellitus.

This prospective hospital-based, case-control study compares the outcome of unstable angina in non-insulin dependent diabetic patients and non-diabetic control subjects. One hundred and sixty-two diabetic patients and 162 non-diabetic control patients with unstable angina were entered into the study. The 3-month mortality was 8.6% (95% confidence interval, CI = 4.4-12.9%) in diabetic patients and 2.5% (CI = 0.1-4.9%) in control patients (p = 0.014). The 1-year mortality was 16.7% (CI = 10.9%-22.4%) in diabetic patients and 8.6% (CI = 4.4%-12.9%) in non-diabetic patients (p = 0.029). Diabetic patients received beta-blockade and underwent coronary angiography and angioplasty less frequently than controls; the frequency of unstable angina, of acute myocardial infarction, and coronary artery bypass grafting was similar in both groups at 1 year of follow-up. It is concluded that diabetic patients with unstable angina have a higher mortality than non-diabetic patients and that this difference is largely accounted for by early (first 3 months) mortality.

The prognostic value of blood glucose in diabetic patients with acute myocardial infarction.

The aim of the study was to investigate prospectively the prognostic value of blood glucose on admission in diabetic and non-diabetic patients with an acute myocardial infarction. Three hundred and thirty-three diabetic and 565 non-diabetic patients were admitted with acute myocardial infarction during the study period of 3.5 years. There was a significant association between mortality and blood glucose on admission in diabetic patients (regression coefficient, r = 0.92, 0.5 < p < 0.02) but not in non-diabetic individuals (r = 0.69, 0.2 < p < 0.5). Age- and sex-standardized mortality was higher in the diabetic group (12.2% vs 7.4%, p < 0.03), but was identical if standardized also for blood glucose on admission. We conclude that a high blood glucose on admission is a bad prognostic indicator in a diabetic patient with an acute myocardial infarction. The excess mortality in diabetic patients with acute myocardial infarction can be attributed to the higher proportion with hyperglycaemia.

Absence of circadian variation in the onset of acute myocardial infarction in diabetic subjects.

OBJECTIVES: To investigate the circadian pattern of acute myocardial infarction in non-insulin-dependent diabetic patients and to compare it with that of controls. BACKGROUND: Previous studies have shown that there is a circadian variation in the incidence of acute myocardial infarction, but there are few data on diabetic subjects. METHODS: A hospital based prospective case-control study. RESULTS: 196 diabetic patients and 196 age and sex matched controls were admitted with a diagnosis of acute myocardial infarction during the study period. IN 32 diabetic patients and 38 controls, the time of onset of myocardial infarction was unknown; in 34, 44, 42, and 44 diabetic patients the onset was in the first to fourth quarters respectively (chi 2 = 1.66, NS). The corresponding figures for the controls were 30, 56, 45, and 27 (chi 2 = 13.9, P < 0.005). The difference between the two groups was highly significant (chi 2 = 10.3, P < 0.025). CONCLUSIONS: Diabetic subjects do not show a significant circadian variation in the onset of acute myocardial infarction.

A computerized health screening and follow-up system in diabetes mellitus.

A computerized population health problem targeting program for diabetes mellitus and other common non-communicable disease was tested at St Luke's Hospital, Malta. The program utilizes a patient questionnaire by dialogue with a computer lasting about 20 min. The system evaluates and targets health problems that are followed up through the database. During a period of 10 months, two groups of people were screened using the system, consisting of 128 recently diagnosed diabetic patients presenting consecutively and 320 people from the general population. The age distributions of the two groups were similar. The system indicated 27% of the control group as being within the Diabetes Risk Group; 5% of this control group were confirmed to have diabetes. Eighty-two percent of newly referred diabetic patients were detected, giving false positive results in 23% and a false negative result in 18% of cases. The classification rules in the system were tuned to the population of Moscow, Russia. We have since adjusted these to better suit the Maltese population. The adjusted rules now indicate 20% of the general population as being within the risk group and have correctly detected 84% of the diabetic people, giving a false positive result in 15% and a false negative result in 16% of cases.

Factors that influence outcome in diabetic subjects with myocardial infarction.

OBJECTIVE: To compare the outcome of acute myocardial infarction in NIDDM patients and nondiabetic control subjects. The relation of glycemic control, duration of diabetes, and major diabetic complications to the outcome of acute myocardial infarction in diabetic subjects was investigated. RESEARCH DESIGN AND METHODS: This was a prospective, hospital-based, case-control study. RESULTS: One hundred and ninety-six NIDDM patients and 196 nondiabetic control subjects with acute myocardial infarction were entered into the study. 23.5% of diabetic subjects and 34.2% of control subjects received thrombolytic therapy (P < 0.05). Diabetic subjects showed signs of reperfusion less often than control subjects (P < 0.05). Mortality was higher in the diabetic group (17.3 vs. 10.2%, P < 0.05). Pump failure (38.3 vs. 16.8%, P < 0.01) and cardiogenic shock (9.7 vs. 3.6%, P < 0.05) also occurred more frequently in diabetic subjects. Loss of heart rate variability was correlated with both pump failure and mortality; proliferative retinopathy was correlated with pump failure. Glycemic control and other diabetic complications did not correlate with outcome. CONCLUSIONS: Our findings confirm the higher mortality and incidence of pump failure in acute myocardial infarction with co-morbid diabetes. They suggest that the less frequent use of thrombolytic therapy, lower reperfusion rates, and more advanced coronary artery disease might be contributory. The presence of autonomic neuropathy and microvascular disease probably also contribute to poor outcome; other major diabetic complications and diabetic control did not influence outcome.

Ossifying fibromyxoid tumour of soft parts: immunohistochemical and ultrastructural analysis.

Ossifying fibromyxoid tumour of soft parts is a recently described benign neoplasm which usually presents in soft tissue. The histogenesis or pattern of differentiation is a source of controversy. Thirteen cases are reported herein. All arose in adults, principally on the upper trunk or head and neck region. None recurred. All but one tumour showed a shell of lamellar bone, laid down by reactive osteoblasts, at the tumour-host interface. The characteristic laciform, glomoid and fascicular patterns, usually in combination, necessitate differential diagnosis from chondroid, smooth muscle and neural tumours especially. Immunohistochemistry revealed positivity for S-100 protein in 10/12, desmin in 7/10 and smooth muscle actin in 4/8. Ultrastructural examination of four cases revealed prominent intermediate filaments, without myofilamentous organization, and a discontinuous external lamina. Immunoelectronmicroscopy localized desmin positivity to the filamentous meshwork. Differentiation therefore appears to take the form of an incomplete neural and smooth muscle phenotype, without evidence of complete maturation.

Microglandular adenosis, apocrine adenosis, and tubular carcinoma of the breast. An immunohistochemical comparison.

Four cases of microglandular adenosis (MA), together with four cases of apocrine adenosis (AA) and 10 cases of tubular carcinoma (TC) of the breast were studied at the light and immunohistochemical level. One case of MA was studied with electron microscopy. MA is characterized by an absence of myoepithelial cells (ME), epithelial membrane antigen (EMA), and gross cystic disease fluid protein (GCDFP-15). The absence of EMA in MA makes it unique among benign glandular hyperplasias of the breast. AA contains myoepithelial cells and a distinct basal lamina. It is characterized by the presence of GCDFP-15, the specific apocrine marker, which is not present in MA. TC lacks both myoepithelial cells and a basal lamina. It is negative for GCDFP-15. Periductal and vascular elastosis are common and usually prominent, whereas they are not found in either MA and AA. Other stromal changes further distinguish the three lesions. These three distinct entities can be separated objectively and unequivocally and it is essential that this be done so as to prevent confusion.

Pleomorphic lobular carcinoma of the breast: an aggressive tumor showing apocrine differentiation.

Pleomorphic lobular carcinoma of the breast is a recently recognized subtype of invasive lobular carcinoma (ILC). Cytologic features are pleomorphic to a degree that contrasts with the cytologic uniformity of classic ILC. It is this feature that simultaneously gives its name to the tumor and highlights the difficulty of identifying it correctly and distinguishing it from ductal carcinoma. In our series of 10 cases, six tumors also contained lobular carcinoma in situ. Nodal metastases were typically sinusoidal. All tumors showed the dissociated, linear, and single file pattern of classic ILC, together with a targetoid distribution. Intracytoplasmic lumina were present in 50% of the tumors. An eosinophilic, slightly granular cytoplasm suggests the possibility of apocrine differentiation, a suggestion derived also from the frequent presence of foamy cells, a cell type previously identified in histiocytoid lobular carcinoma and shown to have apocrine features. The GCDFP-15 apocrine marker was positive in all 10 tumors, while all control ILCs were negative, confirming the presence of apocrine differentiation in pleomorphic lobular carcinoma. Six of 10 patients died within 42 months of diagnosis. Three other patients developed recurrence or distant metastases at short intervals. Pleomorphic lobular carcinoma is a very aggressive tumor. This behavior is perhaps predictable on the basis of tumor size at presentation and the frequency of nodal metastases. Since grading of lobular carcinoma is difficult, recognition of the pleomorphic subtype is useful in identifying a lethal variant.