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.

Computerized back postural assessment in physiotherapy practice: Intra-rater and inter-rater reliability of the MIDAS system.

BACKGROUND AND PURPOSE: Assessment of spinal posture during physiotherapy practice is routine, yet few objective measures exist to this end. The Middlesbrough Integrated Digital Assessment System (MIDAS) is a low cost portable system able to record 3D information on posture. The purpose of this study was to assess both the intra-rater and inter-rater reliability of the MIDAS system. METHODS: Twenty-five healthy subjects were recruited. A repeated measures design was used to record fifteen pre-palpated landmarks on the back of each subject. To limit the sources of variability, the principal researcher palpated the landmarks for each subject. Each of three raters took two measurements on each subject in a standardized upright posture. X (medio-lateral), Y (antero-posterior) and Z (height) landmark positions were recorded via a computer interface. RESULTS: Both intra-rater agreement (mean ICCs - rater 1 r=0.970, rater 2 r=0.965 and rater 3 r=0.965, p< 0.001) and inter-rater agreement (mean ICCs r=0.967, p< 0.001) was very high between repeated measures and between markers. Error values for the z-axis (height) were the lowest. CONCLUSIONS: The MIDAS demonstrated both high inter-rater and intra-rater reliability and provides an objective method for the assessment of posture in physiotherapy practice.

Fear of visual loss in patients with diabetes: results of the prevalence of diabetic eye disease in Tayside, Scotland (P-DETS) study.

AIMS: To describe the relationship between fear of visual loss and dependent variables (visual acuity, retinopathy treatment, severity of retinopathy) in community-based diabetic patients. METHODS: Subjects were identified from the Diabetes Audit and Research in Tayside, Scotland (DARTS) diabetes register. From a total of 4825 individuals known to have diabetes and who were resident in Dundee and Perth (population 216 204; diabetes prevalence 2.23%), 586 persons with diabetes were randomly selected. Participants completed a self-administered questionnaire in Likert grade format which incorporated two items addressing presence and intensity of fear of visual loss. RESULTS: Questionnaires were returned by 61.4% of the cohort. Fear of visual loss was 'often in mind' for 37% of respondents, and that fear was intense for 47.4%. Analysis by diabetes type revealed differences in reported fear of Type 1 and Type 2 patients in relation to disease and treatment variables. Linear regression highlighted the complexity of the issue with retinal status, acuity and treatment only partly explaining reported patient concern (r(2) range: 0.051-0.125 for presence of fear; 0.026-0.04 for intensity of fear, depending on diabetes type). CONCLUSIONS: Fear of visual loss is preoccupying and intense for a substantial proportion of the diabetic population. Reasons for this are multiple and complex. Objective measures of visual impairment and retinal status are inadequate predictors of fear. Carers and researchers need to be mindful of this when approaching patients with diabetes.

3D back shape in healthy young adults: an inter-rater and intra-rater reliability study.

UNLABELLED: Whilst postural evaluation of spinal dysfunction is routine in physiotherapy practice, objective measurements are rarely undertaken due to the scarcity of reliable low cost assessment tools. Warren et al [12] found high intrarater reliability but inter-rater reliability has not as yet been evaluated. The purpose of this study was to assess both the intra-rater and inter-rater reliability of the Middlesbrough Integrated Digital Assessment system (MIDAS). METHODS: A convenience sample of twenty-five healthy University of Teesside students was recruited for the study. One rater palpated fifteen key landmarks on each subjects back. Each of three raters took two measurements on each subject in a standardized upright posture. Rater order was randomized to minimize data recording bias. X (medio-lateral), Y (antero-posterior) and Z (height) landmark positions were recorded via a computer interface. DATA ANALYSIS: Intraclass Correlation Coefficients (ICC 2,1) were used to analyse data using SPSS v13. RESULTS: Both intra-rater agreement (mean ICCs - rater 1 r= 0.970, rater 2 r= 0.965 and rater 3 r= 0.965, p<0.001) and inter-rater agreement (mean ICCs r = 0.967, p<0.001 was very high between repeated measures and between markers. Error values for the z-axis (height) were lowest. CONCLUSIONS: The system demonstrated both high inter-rater and intra-rater reliability. Before the system is used on a clinical population, data output needs to be converted from raw format to a clinically applicable format. Work is currently being undertaken to develop an interactive visual display and control for postural sway.

Stratification of foot ulcer risk in patients with diabetes: a population-based study.

This trial assessed whether a simple clinical tool can be used to stratify patients with diabetes, according to risk of developing foot ulceration. This was a prospective, observational follow-up study of 3526 patients with diabetes (91% type 2 diabetes) attending for routine diabetes care. Mean age was 64.7 (range 15-101) years and duration of diabetes was 8.8 (+/-1.5 SD) years. Patients were categorised into 'low' (64%), 'moderate' (23%) or 'high' (13%) risk of developing foot ulcers by trained staff using five clinical criteria during routine patient care. During follow-up (1.7 years), 166 (4.7%) patients developed an ulcer. Foot ulceration was 83 times more common in high risk and six times more in moderate risk, compared with low-risk patients. The negative predictive value of a 'low-risk score' was 99.6% (99.5-99.7%; 95% confidence interval). This clinical tool accurately predicted foot ulceration in routine practice and could be used direct scarce podiatry resources towards those at greatest need.

The annual incidence of diabetic complications in a population of patients with Type 1 and Type 2 diabetes.

AIM: The DARTS diabetes register was used to determine incidence rates of diabetes and related complications in 1997. METHODS: The diabetes register records detailed clinical information for all patients diagnosed with diabetes in Tayside, Scotland. The study population included patients who were alive and registered with a Tayside GP for the duration of 1997 or who died in Tayside during this time. Patients who had diabetes prior to 1997, those who developed diabetes in 1997, and those who developed diabetic complications in 1997, were identified. RESULTS: In the Tayside population of 385 774 at the start of 1997, there were 942 and 6632 patients with Type 1 and Type 2 diabetes, with a further 29 and 744 patients diagnosed in 1997. The incidence rates (with 95% confidence intervals) of diabetic complications per 1000 patients with Type 1 and Type 2 diabetes, respectively, were: angina 8.8 (4.5-17.3) and 38.4 (33.4-44.2); myocardial infarction 8.6 (4.4-16.9) and 21.9 (18.4-25.9); cerebrovascular accident 1.1 (0.3-6.0) and 14.2 (11.6-17.5); lower extremity amputation 3.2 (1.2-9.4) and 3.1 (2.1-4.8); peripheral vascular disease 5.5 (2.4-12.8) and 13.6 (11.0-16.8); registered blindness 1.1 (0.3-5.9) and 1.6 (0.9-2.9); end-stage renal failure 6.4 (3.0-13.8) and 5.0 (3.6-7.0). Mortality was 14.6 per 1000 (9.6-25.7) in Type 1 diabetes and 50.0 per 1000 (45.1-55.3) in Type 2 diabetes. CONCLUSION: This study provides baseline figures for rates of diabetic complications for Type 1 and Type 2 diabetes, and confirms the increased burden of macrovascular disease in Type 2 diabetes.

Prevalence of diabetic eye disease in Tayside, Scotland (P-DETS) study: methodology.

AIMS: To describe the use of a validated diabetes register for sampling frame generation and assessment of the representative nature of participants in a fieldwork study of diabetic eye disease. METHODS: We performed an observational, cross-sectional fieldwork study of diabetic retinal disease using reference standard eye examination. We sampled the entire diabetic population using the Diabetes Audit and Research in Tayside Study (DARTS) diabetes register. RESULTS: The study population comprised 4825 diabetic patients aged over 16 years registered with one of 166 general practitioners (GPs) in 41 practices in Tayside in October 1999. This represented 61.1% of the Tayside diabetic population (7903). A total of 586 (66%; 95% confidence interval 63, 70) patients were examined from a sampling frame of 882 living patients registered with a Tayside GP. Demographic and disease parameters recorded on the DARTS patient register allowed comparison between participants and non-participants. CONCLUSIONS: This study shows the clear benefit of using a complete diabetic population as a sampling frame. This allows potential selection bias and external validity to be evaluated using routine data sources. Studies performed and reported in this way will aid the critical appraisal process.

Venous pH can safely replace arterial pH in the initial evaluation of patients in the emergency department.

OBJECTIVE: This study aims to determine the extent of correlation of arterial and venous pH with a view to identifying whether venous samples can be used as an alternative to arterial values in the clinical management of selected patients in the emergency department. METHODS: This prospective study of patients who were deemed by their treating doctor to require an arterial blood gas analysis to determine their ventilatory or acid-base status, compared pH on an arterial and a venous sample taken as close to simultaneously as possible. Data were analysed using Pearson correlation and bias (Bland-Altman) methods. RESULTS: Two hundred and forty six patients were entered into the study; 196 with acute respiratory disease and 50 with suspected metabolic derangement. The values of pH on arterial and venous samples were highly correlated (r=0.92) with an average difference between the samples of -0.4 units. There was also a high level of agreement between the methods with the 95% limits of agreement being -0.11 to +0.04 units. CONCLUSION: Venous pH estimation shows a high degree of correlation and agreement with the arterial value, with acceptably narrow 95% limits of agreement. Venous pH estimation is an acceptable substitute for arterial measurement and may reduce risks of complications both for patients and health care workers.

How accurate are pulse oximeters in patients with acute exacerbations of chronic obstructive airways disease?

The aim of this study was to determine the extent of correlation and agreement between arterial oxygen saturation and oxygen saturation as recorded by transcutaneous pulse oximetry, with a view to identifying whether pulse oximetry can be used as an alternative to arterial values in the clinical management of patients with acute exacerbations of chronic obstructive airways disease (COAD) in the emergency department. It also aims to determine whether there is a cut-off level of oxygen saturation by pulse oximetry that can screen for significant systemic hypoxia in this group. This prospective study of patients with acute exacerbations of COAD who were deemed by their treating doctor to require an arterial blood gas analysis to determine their ventilatory status, compared arterial oxygen saturation with simultaneously recorded oxygen saturation measured by transcutaneous pulse oximetry. Data were analysed using Pearson correlation, bias plot (Bland-Altman) methods for agreement and the receiver operator characteristic (ROC) curve method for determination of a screening cut-off. Sixty-four sample-pairs were analysed for this study. Nine (14%) had significant hypoxia (arterial PO2 less than 60 mmHg). The correlation coefficient was 0.91. The bias (Bland-Altman) plot shows a constant bias of -0.758% and only fair agreement, with 95% limits for agreement of -8.2 to + 6.7%. With respect to the ROC curve analysis, the 'best' cut-off for detection of hypoxia was at oxygen saturation by pulse oximetry of 92% (sensitivity 100%, specificity 86%). In conclusion, there is not sufficient agreement for oxygen saturation measured by pulse oximetry to replace analysis of an arterial blood gas sample in the clinical evaluation of oxygenation in emergency patients with COAD. However, oxygen saturation by pulse oximetry may be an effective screening test for systemic hypoxia, with the screening cut-off of 92% having sensitivity for the detection of systemic hypoxia of 100% with specificity of 86%.

Diabetes and lower-limb amputations in the community. A retrospective cohort study. DARTS/MEMO Collaboration. Diabetes Audit and Research in Tayside Scotland/Medicines Monitoring Unit.

OBJECTIVE: There are few U.K. data on the incidence rates of amputation in diabetic subjects compared with the nondiabetic population. RESEARCH DESIGN AND METHODS: We performed a historical cohort study of first lower-extremity amputations based in Tayside, Scotland (population 364,880) from 1 January 1993 to 31 December 1994. The Diabetes Audit and Research in Tayside Scotland (DARTS) database was used to identify a prevalence cohort of 7,079 diabetic patients on 1 January 1993. We estimated age-specific and standardized incidence rates of lower-limb amputations in the diabetic and nondiabetic cohorts. Results were compared with a previous study that evaluated lower-extremity amputations in diabetic patients in Tayside in 1980-1982. RESULTS: There were 221 subjects who underwent a total of 258 nontraumatic amputations. Of the 221 subjects, 60 (27%) patients were diabetic (93% NIDDM), and 63% were first amputations. The median duration of diabetes was 6 years (range: newly diagnosed to 41 years). Nonhealing ulceration (31%) and gangrene (29%) were the two main indications for amputation in the diabetic subjects. Of the 161 nondiabetic subjects, 140 (80%) underwent first amputations. The adjusted incidences in the diabetic and nondiabetic groups were 248 and 20 per 100,000 person-years, respectively. Tayside patients with diabetes thus had a 12.3-fold risk of an amputation compared with nondiabetic residents (95% CI 8.6-17.5). The estimated proportion of diabetic patients in the population rose from 0.81% in 1980-1982 to 1.94% in 1993-1994, whereas the absolute rate of amputation in diabetic subjects was unchanged from that in 1980-1982. CONCLUSIONS: These population-based U.K. amputation data are similar to amputation rates in the U.S. Amputation rates appear to have decreased significantly since 1980-1982. The impact of diabetes education and prevention programs that target the processes leading to amputation can now be evaluated.

Do H2-receptor antagonists cause acute pancreatitis?

The aim of this study was to investigate the association between H(2)-receptor antagonists and acute pancreatitis. The automated database of the Medicines Monitoring Unit (MEMO) was used to carry out a case-control study, supplemented with information on possible confounding factors from hospital and GP medical records. Cases were patients hospitalized with a computerized diagnosis of acute pancreatitis, and two sets of controls were drawn from (1) the study population and from (2) the same GP practice as the case. Current or 60-day exposure to cimetidine and ranitidine was analysed. In adjusted analyses, cimetidine exposure and ranitidine exposure were associated with an increased risk of hospitalization for acute pancreatitis, as were alcohol abuse and cholelithiasis. The risks were lower in unadjusted analyses, suggesting that the association is confounded, although they did not disappear completely. A possible explanation is that data on confounding were incomplete. This study cannot discount the existence of an association between H(2)-antagonists and acute pancreatitis, and highlights the difficulties involved in obtaining complete and accurate data on confounding factors that are not collected routinely.

A study to determine the sensitivity and specificity of hospital discharge diagnosis data used in the MICA study.

AIMS: To determine the sensitivity and specificity of each ICD9 code for a diagnosis of definite or possible myocardial infarction (MI) from the perspective of the Myocardial Infarction Causality Study (MICA) and to use these data to estimate the likely number of MICA cases in Scotland that would be undetected were these codes omitted from the study. SETTING: Women resident and registered with general practitioners in the Tayside region of Scotland between October 1993 and October 1995. METHOD: All SMR1 records of Tayside hospitalizations containing ICD9 (International Classification of Diseases, ninth revision) codes for myocardial infarction (410) or possible myocardial infarction (411, 412, 413, 414, 427.4, 427.5, 786.5) were identified for women aged between 16 and 44 years between 1 October 1993 and 15 October 1995. Original case records were sought and each episode abstracted using a predefined form. Records were independently scrutinized by two consultant cardiologists blinded to the SMR1 code. Cases were categorized as definite MI, possible MI or unlikely MI. Where there was disagreement between the two cardiologists, the profiles for such events were examined by a third cardiologist who acted as the final adjudicator. The adjudicator's verdict was, in this study, considered dominant. The sensitivity, specificity and positive predictive value of each ICD9 code was determined. RESULTS: Two hundred and fifty-three women fulfilled the SMR1 search criteria. Case records of 204 (81%) were retrieved but four case records contained no data on the admission of interest and were classified as invalid. Forty-six of the 200 remaining patients were ineligible for the MICA study leaving 154 records for evaluation. There were 12 patients who had a discharge code for MI (ICD9 410). Of these, 11 were judged as a definite MI by both cardiologists. One event (discharge code ICD9 410) was judged as 'possible' by one cardiologist and 'unlikely' by the other. The adjudicator subsequently judged this event as 'definite'. Another six events were subsequently judged as 'possible'. Thus, after adjudication, 12 cases of definite MI and six cases of 'possible' MI were identified. The sensitivity and specificity of ICD9 code 410 was 67% and 100% respectively. The positive predictive value was 100%. The sensitivity of code 411 was 5.6%. The specificity was 99% and the positive predictive value was 50%. Code 413 had a sensitivity of 5.6% with a specificity of 94% and a positive predictive value of 9.1%. Code 414 also had a sensitivity of 5.6%. The specificity was 86% and the positive predictive value was 4.5%. Code 786.5 had a sensitivity of 17%, a specificity of 23% and a positive predictive value of 2.5%. Code 427.5 failed to identify any definite or possible cases. CONCLUSIONS: In the MICA Study, ICD9 code 410 was found to be the most robust. All 12 patients judged to have had a definite MI had the appropriate discharge code (ICD9 410). The six patients judged to have had a possible MI all had discharge codes other than that for MI (410). However, identifying these six patients required the validation of a further 160 events-giving a combined sensitivity of 33%, a specificity of 0% and a positive predictive value of only 3.8%. The use of ICD9 codes 411, 413, 414, 427.5 and 786.5 must, therefore, only be employed when circumstances fully justify the additional workload.

Possible modification of metastasis from adenocarcinoma of the prostate by colchicine: a case report.

Laboratory data indicate that colchicine has an antimetastatic effect in tissue culture and in tumor-transplantation experiments in animals. The present case report reveals a lack of perineural and capsular invasion as well as distant metastases from a large adenocarcinoma of the prostate in a 63-year-old patient who had taken colchicine daily for 25 years prior to lesion discovery. Failure to demonstrate metastasis was unexpected both because of lesion size (estimated volume 4.4 ml) as well as its histopathology (Gleason pattern 3S, grade 6). Colchicine may have inhibited metastasis of activated Ki-ras oncogenes during oncogenesis along neural microtubules in the area because of the known inhibitory effect of this drug on particle transport along the microtubule component of the cytoskeleton. Colchicine at therapeutic doses for gout may simultaneously inhibit metastasis of other types of malignancies in man.

Simultaneous nonlinear absorption and index effects in the propagation of intense TEA CO2 laser pulses through CDF3.

Changes in the beam profile of the CO2 laser 10R(26) line, caused by transmission through, and absorption by, CDF3 were studied using an array of pyroelectric detectors. During the propagation of the laser beam through CDF3, nonlinear absorption and self-defocusing of the beam have both been determined from measurements of the effect on the exit beam of fluence, radiant energy, CDF3 pressure, transmission cell length, and distance from the exit of the cell to the detector array.

Avidin-biotin technique is more sensitive than lectin assay for detecting the Thomsen-Friedenreich antigen (T-antigen) in transitional cell carcinoma of the bladder.

Avidin biotin technique and lectin assay has been compared in a double-blind study for detection of the T-antigen in transitional carcinoma of the bladder. Utilizing the tumor registry from the U.S. Naval Hospital in Bethesda, Maryland, patients with transitional cell carcinoma of the bladder were identified. Thirty-three patients were selected with a total of 43 specimens. Tissues from 26 patients with a total of 43 specimens that showed no lesions and had no known history of genitourinary diseases were used as controls. These tissues were studied for the presence of T-antigen utilizing avidin biotin or lectin techniques. T-antigen was detected in 60% of the specimens with lectin technique, while 95% was detected with avidin biotin methods. The T-antigen was not detected by either method even after the treatment with neuraminidase in six patients. These patients had high grade and high stage tumors. This study demonstrated that normal urothelium has concealed T-antigen that can be exposed by treating the tissue with neuraminidase. However, the T-antigen is unconcealed in low grade tumor but disappears in high grade invasive tumor. Avidin biotin technique appears to be a more sensitive method for detecting the presence or absence of the T-antigen.

Immunoperoxidase versus specific red cell adherence in detection of ABO(H) antigens on normal urothelium. Double-blind study.

In this study we compared the sensitivity of SRCA for detecting A, B, O(H) blood group antigens on the urothelial surface of normal renal pelvis, ureter, and bladder to that of immunoperoxidase staining via the avidin-biotin complex (ABC) method. In all, forty-three mucosal specimens from 23 patients were compared. There was little difference between SRCA and immunoperoxidase for the detection of A and of B antigens. H(O) antigen was detected in 94 per cent of the blood group O patients using immunoperoxidase while only 46 per cent were detected using the SRCA method. We therefore concluded that immunoperoxidase was superior to SRCA in detecting the H(O) antigen not only in normal ureter but also in normal renal pelvis and normal bladder.